588 Clinical Fellowship jobs in India
Clinical Research Associate
Mumbai, Maharashtra
Bristol Myers Squibb
Posted today
Job Viewed
Job Description
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Job Title/Role : Clinical Research Associate**
Position Summary: The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.
**Duties/Responsibilities:**
+ Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
+ Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
+ Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.
+ Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level.
+ Motivate and influence sites to meet study objectives, including enrollment and retention goals.
+ Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method
+ Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
+ Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.
+ Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
+ Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
+ Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
+ Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
+ Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.
+ Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
+ May support Ethics Committee submissions, ICF reviews, collection of documents to/from site
+ Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.
+ Support coordination of site activities related to database locks to ensure timelines are met as required locally.
+ Perform timely site closure activities when all required protocol visits and follow-up are completed.
**Qualifications:**
+ Bachelor's degree required, preferably within life sciences or equivalent
+ Valid driver's license (as locally required)
**Experience:**
+ Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role.
+ Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
+ Experience in the drug discovery/development process.
**Competencies:**
+ Knowledge and understanding of clinical research processes, regulations and methodology
+ Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
+ Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities ( Analytical thinking/critical thinking skills. Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions ( Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment
+ Organization and time management skills
+ Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders
+ Good verbal and written communication skills (both in English and local language)
+ Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc.)
+ Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning
+ Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
+ Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity
**Software that must be used independently and without assistance:**
+ Microsoft Suite
+ Clinical Trial Management Systems (CTMS)
+ Electronic Data Capture Systems (eDC)
+ Electronic Trial Master File (eTMF)
+ RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :00:59.538 UTC
**Location:** Mumbai-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Job Title/Role : Clinical Research Associate**
Position Summary: The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.
**Duties/Responsibilities:**
+ Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
+ Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
+ Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.
+ Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level.
+ Motivate and influence sites to meet study objectives, including enrollment and retention goals.
+ Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method
+ Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
+ Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.
+ Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
+ Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
+ Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
+ Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
+ Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.
+ Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
+ May support Ethics Committee submissions, ICF reviews, collection of documents to/from site
+ Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.
+ Support coordination of site activities related to database locks to ensure timelines are met as required locally.
+ Perform timely site closure activities when all required protocol visits and follow-up are completed.
**Qualifications:**
+ Bachelor's degree required, preferably within life sciences or equivalent
+ Valid driver's license (as locally required)
**Experience:**
+ Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role.
+ Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
+ Experience in the drug discovery/development process.
**Competencies:**
+ Knowledge and understanding of clinical research processes, regulations and methodology
+ Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
+ Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities ( Analytical thinking/critical thinking skills. Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions ( Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment
+ Organization and time management skills
+ Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders
+ Good verbal and written communication skills (both in English and local language)
+ Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc.)
+ Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning
+ Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
+ Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity
**Software that must be used independently and without assistance:**
+ Microsoft Suite
+ Clinical Trial Management Systems (CTMS)
+ Electronic Data Capture Systems (eDC)
+ Electronic Trial Master File (eTMF)
+ RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :00:59.538 UTC
**Location:** Mumbai-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
This advertiser has chosen not to accept applicants from your region.
0
Clinical Research Associate
Sun Pharmaceuticals, Inc
Posted 2 days ago
Job Viewed
Job Description
**Job location:** Chennai
**YOUR TASKS AND RESPONSIBILITIES:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**WHO YOU ARE:**
+ Minimum qualification requirement is to have a Bachelor's or Masters degree in a health(1)related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
+ Relevant experience of 1-5 years minimum in the field of Clinical Research
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
**YOUR TASKS AND RESPONSIBILITIES:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**WHO YOU ARE:**
+ Minimum qualification requirement is to have a Bachelor's or Masters degree in a health(1)related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
+ Relevant experience of 1-5 years minimum in the field of Clinical Research
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.
1
Clinical Research Coordinator
Bengaluru, Karnataka
ClinoGenesis Research Institute
Posted today
Job Viewed
Job Description
Clinical Research Coordinator (Freshers Only)
Location: Hybrid/work from home
Organization: Clinogenesis Research Organization
Department: Clinical Operations
Employment Type: Full-Time
About US
Clinogenesis Research Organization is a leading contract research organization committed to advancing clinical excellence and innovation. We partner with global clients to deliver high-quality, compliant, and ethically sound clinical research solutions. At Clinogenesis, we believe in nurturing new talent and providing a structured pathway for growth in the clinical research industry.
Position Overview
We are seeking motivated and detail-oriented Clinical Research Coordinators to join our Clinical Operations team. This entry-level position is designed for fresh graduates who wish to build a professional career in clinical research. The selected candidates will gain hands-on exposure to the execution and coordination of clinical trials in compliance with regulatory and ethical standards.
Key Responsibilities
- Assist in the coordination and conduct of clinical trials under supervision.
- Support investigators and site teams in maintaining protocol compliance and accurate data capture.
- Maintain essential trial documentation, logs, and case report forms in accordance with GCP and SOP requirements.
- Ensure adherence to ICH-GCP guidelines, applicable regulations, and ethical standards.
- Participate in organizational training, meetings, and performance reviews to enhance professional competence.
Eligibility Criteria
- Education: B.Pharm, M.Pharm, B.Sc / M.Sc in Life Sciences, Pharmacy, Nursing, or related healthcare disciplines.
- Experience: Freshers only (candidates with prior industry experience will not be considered).
- Strong communication, documentation, and organizational skills.
- High level of integrity, attention to detail, and eagerness to learn.
What We Offer
- Structured onboarding and mentorship under industry experts.
- Exposure to global clinical operations and regulatory practices.
- Continuous professional training and growth opportunities.
Apply now or send your resume to
This advertiser has chosen not to accept applicants from your region.
2
Clinical Research Coordinator
Delhi, Delhi
MS CLINICAL RESEARCH
Posted 5 days ago
Job Viewed
Job Description
About the Job
We are looking for passionate Clinical Research Coordinators (CRC) to join our growing team. This is an exciting opportunity for fresh graduates with a clinical research course or background in life sciences/pharmacy who want to build a career in clinical trials and research.
Position Details
Role: Clinical Research Coordinator
Location: Delhi
Employment Type : Full-time
Experience: Freshers with clinical research training or related background encouraged to apply!
Key Responsibilities
- Conduct clinical trials in compliance with ICH GCP and protocol guidelines.
- Support study start-up activities and assist with site initiation.
- Participate in recruitment and retention of study subjects.
- Complete and maintain source documents, CRFs, and logs accurately.
- Compile and update the Site Master File.
- Manage Investigational Products (IP), including accountability and shipping.
- Coordinate submissions and communication with the Ethics Committee.
- Update sponsors on study progress and prepare for monitoring visits.
- Perform other responsibilities assigned by management.
Who Can Apply
- Freshers with a completed Clinical Research course.
- Graduates/postgraduates in Life Sciences, Pharmacy, Biotechnology, or related fields.
- Strong interest in clinical trials and regulatory compliance.
- Excellent organisational, communication, and documentation skills.
Why Join Us?
Gain hands-on experience in clinical trials.
Learn directly from experienced professionals.
Be part of innovative projects that shape the future of healthcare.
A great opportunity to grow your career in clinical research.
This advertiser has chosen not to accept applicants from your region.
3
Clinical Research Associate
122001 Gurgaon, Haryana
₹650000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate to join their team in **Gurugram, Haryana, IN**. This critical role involves overseeing and managing clinical trials to ensure data accuracy, patient safety, and adherence to regulatory guidelines. You will be responsible for site selection and initiation, monitoring study progress, and ensuring compliance with protocols and Good Clinical Practice (GCP) standards. The ideal candidate will possess a strong understanding of clinical trial processes, regulatory requirements, and medical terminology. Excellent organizational, communication, and interpersonal skills are essential for effective site management and data collection. Responsibilities include conducting routine site visits, resolving issues at study sites, verifying source documentation against case report forms, and ensuring timely data entry. You will also be responsible for managing study supplies and ensuring the ethical conduct of research. This is an on-site position requiring regular travel to clinical trial sites. We are looking for a proactive individual with a keen eye for detail and a commitment to scientific integrity. The ability to manage multiple studies simultaneously and maintain strong relationships with investigators and site staff is crucial. This is an exciting opportunity to contribute to the development of life-saving therapies and advance your career in pharmaceutical research within a reputable organization. You will play a vital role in bringing innovative treatments from development to market, ensuring the highest standards of safety and efficacy are met throughout the clinical trial process.
This advertiser has chosen not to accept applicants from your region.
4
Clinical Research Associate
201301 Ghaziabad, Uttar Pradesh
₹70000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client, a leading pharmaceutical organization, is seeking an experienced and dedicated Clinical Research Associate (CRA) to join their globally distributed team. This is a fully remote position, offering the flexibility to work from anywhere. As a CRA, you will play a vital role in ensuring the successful execution of clinical trials by monitoring study sites, verifying data accuracy, and ensuring compliance with regulatory standards and protocols. You will be responsible for managing multiple sites, building strong relationships with investigators and site staff, and contributing to the advancement of life-saving therapies. This role demands a high level of professionalism, meticulous attention to detail, and a strong understanding of clinical research principles.
Key Responsibilities:
Key Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits to assigned clinical sites.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
- Ensure adherence to the study protocol, Good Clinical Practice (GCP) guidelines, and applicable regulations.
- Identify, evaluate, and select potential clinical investigators and sites.
- Train and provide ongoing support to site staff regarding study procedures and requirements.
- Manage communication between study sites, the sponsor, and other relevant parties.
- Resolve site-level issues and escalate critical matters to the project manager as needed.
- Ensure timely submission of all required regulatory and ethical documentation from sites.
- Oversee subject recruitment and retention efforts at assigned sites.
- Prepare monitoring visit reports and follow up on action items.
- Maintain accurate and up-to-date site files and study documentation.
- Contribute to the development and review of study-related documents, such as protocols and case report forms.
- Ensure the safety and well-being of study participants.
- Manage study timelines and deliverables for assigned sites.
- Stay abreast of current trends and developments in clinical research and pharmaceutical development.
- Bachelor's degree in a life science, nursing, or related discipline. Advanced degree preferred.
- Minimum of 2-3 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Proven experience in site monitoring and data verification.
- Excellent understanding of clinical trial processes and drug development.
- Strong organizational and time management skills.
- Exceptional written and verbal communication abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and remotely, with a high degree of self-discipline and accountability.
- Willingness to travel to sites as required (if applicable, but this role is remote-first).
- Critical thinking and problem-solving skills.
- Detail-oriented with a commitment to quality and accuracy.
This advertiser has chosen not to accept applicants from your region.
5
Clinical Research Scientist
751006 Bhubaneswar, Orissa
₹75000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is seeking a highly motivated and accomplished Clinical Research Scientist to join their innovative, fully remote team. This role is critical to the advancement of new therapeutic compounds and requires a candidate with a strong scientific background and experience in clinical trial design and execution. You will be instrumental in overseeing all phases of clinical research, from protocol development to data analysis and reporting, ensuring the highest standards of scientific integrity and regulatory compliance.
Responsibilities:
Responsibilities:
- Design, develop, and implement clinical trial protocols in accordance with regulatory guidelines (e.g., ICH-GCP) and scientific objectives.
- Oversee the conduct of clinical trials, including site selection, initiation, monitoring, and close-out activities.
- Collaborate with cross-functional teams, including medical affairs, regulatory affairs, data management, and biostatistics.
- Analyze and interpret clinical trial data, preparing comprehensive reports for regulatory submissions and scientific publications.
- Ensure compliance with all applicable regulations, ethical standards, and company policies.
- Manage relationships with investigators, clinical research coordinators, and other external stakeholders.
- Contribute to the scientific strategy for drug development programs.
- Prepare and deliver scientific presentations and publications.
- Mentor junior researchers and contribute to a culture of continuous learning and improvement.
- Stay abreast of the latest scientific advancements and therapeutic area developments.
- Ph.D. or M.D. in a life science discipline (e.g., Pharmacology, Biology, Biochemistry, Medicine).
- Minimum of 7 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- Extensive knowledge of clinical trial design, execution, and data analysis.
- Proven experience in protocol development and regulatory submissions.
- Strong understanding of Good Clinical Practice (GCP) and other relevant regulatory requirements.
- Excellent scientific writing and communication skills.
- Demonstrated ability to work effectively in a remote, collaborative environment.
- Strong project management and organizational skills.
- Experience in (Specific therapeutic area, e.g., Oncology, Cardiology) is highly desirable.
- Proficiency in clinical trial management systems and statistical software.
This advertiser has chosen not to accept applicants from your region.
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6
Clinical Research Coordinator
682011 Kochi, Kerala
₹750000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client, a prominent healthcare research institution, is seeking a dedicated and meticulous Clinical Research Coordinator to join their innovative team in **Kochi, Kerala, IN**. This role plays a critical part in the successful execution of clinical trials, ensuring adherence to research protocols, regulatory requirements, and ethical standards. The position offers a hybrid work model, blending essential on-site responsibilities with the flexibility of remote administrative tasks. You will be responsible for managing all aspects of clinical trial coordination, from patient recruitment and screening to data collection and reporting.
Key Responsibilities:
Key Responsibilities:
- Recruit, screen, and enroll eligible participants for clinical trials according to protocol requirements.
- Conduct informed consent process and ensure participant understanding.
- Manage study documentation, including case report forms (CRFs), source documents, and regulatory binders.
- Administer study medications and conduct study procedures as per protocol.
- Monitor participants for adverse events and report them appropriately.
- Collect, manage, and ensure the accuracy and completeness of study data.
- Liaise with principal investigators, study sponsors, ethics committees, and regulatory agencies.
- Coordinate study visits and ensure timely completion of all protocol-related procedures.
- Maintain effective communication with participants and their families.
- Participate in study-related training and meetings.
- Adhere to Good Clinical Practice (GCP) guidelines and institutional policies.
- Manage study supplies and equipment.
- Bachelor's degree in a life science, nursing, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Coordinator or similar role.
- Strong understanding of clinical trial processes, GCP, and regulatory requirements (e.g., ICMR, FDA).
- Excellent organizational, time management, and multitasking skills.
- Proficiency in clinical data management systems and electronic data capture (EDC) tools.
- Exceptional interpersonal and communication skills, with the ability to build rapport with diverse patient populations.
- Attention to detail and commitment to maintaining data integrity.
- Ability to work effectively in a hybrid environment, balancing remote and on-site duties.
- Familiarity with the healthcare landscape in **Kochi, Kerala, IN** is an advantage.
This advertiser has chosen not to accept applicants from your region.
7
Clinical Research Associate
226001 Lucknow, Uttar Pradesh
₹800000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical research organization, is actively recruiting a meticulous and experienced Clinical Research Associate (CRA) to support their innovative drug development programs in Lucknow, Uttar Pradesh . This role is pivotal in ensuring the successful execution of clinical trials according to Good Clinical Practice (GCP) guidelines and regulatory requirements. You will be responsible for site selection, initiation, monitoring, and close-out activities for clinical trial sites. Key duties include verifying patient safety and rights, ensuring data accuracy and integrity, and managing trial-related documentation. The ideal candidate will possess a strong understanding of clinical trial protocols, informed consent processes, and ethical considerations in research. You will conduct regular site visits to assess protocol adherence, review source documents, and resolve any discrepancies or issues that arise. Excellent communication and interpersonal skills are essential for building strong relationships with investigators, site staff, and internal study teams. You will also be responsible for ensuring timely data entry and query resolution. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is required. The ability to manage multiple sites and prioritize tasks effectively in a dynamic environment is crucial. We are seeking a highly organized, detail-oriented professional with a passion for advancing medical treatments. A background in a relevant scientific or healthcare field is essential, along with a proven track record in clinical research. This position offers an exciting opportunity to contribute to the development of life-saving therapies and make a tangible impact on patient health.
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Clinical Research Associate
208002 Kanpur, Uttar Pradesh
₹1200000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking a diligent and motivated Clinical Research Associate (CRA) to join their esteemed pharmaceutical team in Kanpur, Uttar Pradesh, IN . This role is pivotal in ensuring the integrity and quality of clinical trials, from site initiation to study close-out. As a CRA, you will be responsible for monitoring clinical trial sites to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will conduct site visits, review essential documents, verify data accuracy, and ensure patient safety. This hybrid position allows for flexibility, combining remote work with essential on-site monitoring activities. The ideal candidate will possess strong analytical skills, excellent communication abilities, and a deep understanding of pharmaceutical research methodologies. You will work closely with investigators, site staff, and internal project teams to ensure successful trial execution. Building and maintaining positive relationships with clinical sites is crucial for this role. We are looking for an individual who is highly organized, detail-oriented, and committed to advancing medical research through rigorous scientific standards. Your role will involve extensive travel to various study sites within the assigned region. Responsibilities:
- Monitor assigned clinical trial sites to ensure compliance with study protocols, SOPs, and regulatory requirements (GCP, ICH).
- Conduct site visits, including pre-study, initiation, routine monitoring, and close-out visits.
- Verify accuracy and completeness of clinical trial data and essential documents.
- Ensure patient safety and rights are protected at all times.
- Identify and resolve site-level issues and deviations.
- Train and mentor site staff on study-specific procedures.
- Collaborate effectively with investigators, site staff, and internal study teams.
- Prepare accurate and timely monitoring visit reports.
- Maintain effective communication channels with all stakeholders.
- Contribute to the overall success and efficiency of clinical trial execution.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience in site monitoring and clinical trial management.
- Strong understanding of medical terminology and clinical trial processes.
- Excellent written and verbal communication skills.
- Proficiency in clinical trial management software and tools.
- Ability to travel extensively to clinical sites.
- Strong organizational and time management skills.
- High level of accuracy and attention to detail.
This advertiser has chosen not to accept applicants from your region.
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