1,108 Clinical Study jobs in India
Clinical Study Report (Csr) Writer
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**Job Summary**:
Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and regulatory requirements.
**Responsibilities**:
- Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
- Entry of the study data in the required formats / data base for report table preparation and CDISC datasets preparation.
- Performs the collection, recording, retrieval of information, verify the accuracy of the information, manage data storage and retrieval systems.
- Review of report tables.
- Performs the activities related to requisition, receiving and accountability of the forms for the study.
- Ensure readiness of the department to face regulatory audit by following good documentation practices, GCP & relevant SOPs.
- Organizing files and collecting clinical data to be entered into the databases or in required formats.
- Assists in reconciliation of the study data.
- Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
- Perform study activities as per the study specific protocol requirements and other duties as assigned by the Clinical Operations Management/delegate as training and experience allow.
- Responsible for handling (receiving, Issuing, Storage etc.,) of Clinical Study Materials in stores.
- Performs work in accordance with all established regulatory, compliance and safety requirements.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
**Job Requirements**:
- Education
- B.Pharm / Pharm D / B.Sc. in Life Science related filed.
- Knowledge, Skills and Abilities
- Good skills in MS Office.
- Good in Communication skills.
- Flexible to work
- Experience
- 0-2 years in Clinical Reasearch
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Clinical Research Associate
Posted today
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Key Responsibilities:
- Conduct site selection, initiation, interim monitoring, and close-out visits.
- Ensure adherence to protocols, SOPs, GCP, and regulatory requirements at study sites.
- Verify the accuracy, completeness, and integrity of clinical data.
- Manage communication and relationships with investigators and site staff.
- Train site personnel on study procedures and protocols.
- Review essential documents and regulatory binders.
- Prepare monitoring reports and track action items.
- Identify and escalate site-level issues and risks.
- Participate in investigator meetings and provide feedback.
- Ensure timely submission of study-related documentation.
- Proven experience as a Clinical Research Associate (CRA) or similar role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with clinical trial monitoring and site management.
- Strong understanding of medical terminology and clinical research processes.
- Excellent attention to detail and organizational skills.
- Proficiency in data management and electronic data capture (EDC) systems.
- Strong written and verbal communication skills.
- Ability to travel to sites as required.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Working knowledge of study documentation and regulatory submissions.
Clinical Research Associate
Posted today
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Key Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory guidelines (e.g., GCP, ICH).
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Perform source data verification (SDV) and review source documents.
- Manage communication between investigators, site staff, and the sponsor.
- Ensure timely submission of required study documents and reports.
- Oversee the recruitment and enrollment of study participants.
- Train site staff on study protocols and procedures.
- Identify and report adverse events and deviations from protocol.
- Conduct site initiation, monitoring, and close-out visits.
- Maintain organized and up-to-date trial documentation and site files.
- Collaborate with clinical operations teams and data management.
- Ensure the safety and rights of study participants are protected.
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. Advanced degree is a plus.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role.
- In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
- Excellent monitoring, data collection, and documentation skills.
- Strong understanding of medical terminology and disease states.
- Effective communication, interpersonal, and organizational abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required for monitoring.
- Strong analytical and problem-solving skills.
- Commitment to ethical research practices.
Clinical Research Associate
Posted today
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Key Responsibilities:
- Monitor clinical trial sites to ensure adherence to Good Clinical Practice (GCP), protocols, and regulatory requirements.
- Verify the accuracy, completeness, and validity of clinical data collected at study sites.
- Conduct site initiation visits, routine monitoring visits, and close-out visits.
- Manage communication between investigative sites and the study team.
- Train site staff on study protocols, procedures, and data collection requirements.
- Ensure the proper handling and storage of investigational products and study-related materials.
- Identify, document, and resolve site-specific issues and deviations.
- Prepare monitoring reports and follow up on action items with site personnel.
- Facilitate drug accountability and maintain study documentation at investigator sites.
- Collaborate with study statisticians, data managers, and medical monitors.
- Ensure timely submission of all required study documents to regulatory authorities and ethics committees.
- Contribute to the development and review of study protocols and case report forms (CRFs).
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. A Master's degree is preferred.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotech industry.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong understanding of medical terminology and clinical trial processes.
- Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
- Proficient in Microsoft Office Suite, particularly Word, Excel, and PowerPoint.
- Effective communication and interpersonal skills, with the ability to build strong relationships with site staff.
- Ability to travel frequently to clinical sites and work effectively in a hybrid environment.
- Problem-solving skills and the ability to work independently with minimal supervision.
- Experience in oncology or cardiovascular clinical trials is a significant advantage.
Clinical Research Associate
Posted today
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Key Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience with clinical trial monitoring, site management, and data verification.
- Strong understanding of medical terminology and clinical research processes.
- Excellent communication, organizational, and time management skills.
- Ability to travel to sites as required.
- Proficiency in clinical trial management software and EDC systems is a plus.
If you are passionate about clinical research and possess the required expertise, we encourage you to apply.
Clinical Research Associate
Posted today
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Key responsibilities include developing and finalizing clinical trial protocols, managing study documentation, and providing training to study site staff. You will serve as the main point of contact for investigators and study sites, addressing any queries or issues that arise during the trial. The role involves extensive travel to clinical sites across various regions, although the core responsibilities and management are conducted remotely. You will review source documents, electronic data capture (EDC) systems, and investigational product accountability to ensure data quality and compliance. This position requires strong organizational skills, meticulous attention to detail, and the ability to work independently while collaborating effectively with cross-functional teams. We are looking for an individual passionate about advancing medical research and committed to upholding the highest standards of ethical conduct and scientific rigor. Join our client and contribute to bringing life-changing therapies to patients.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical industry.
- In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
- Experience with EDC systems and clinical trial management software.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to manage multiple priorities and meet strict deadlines in a remote work environment.
- Willingness to travel as required for site visits.
Clinical Research Associate
Posted today
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Key responsibilities include verifying data accuracy, managing investigational product, and ensuring compliance with Good Clinical Practice (GCP) guidelines. The CRA will build and maintain strong working relationships with clinical investigators and site staff, providing training and support as needed. Excellent written and verbal communication skills are essential for preparing monitoring reports, communicating with regulatory authorities, and collaborating with internal teams. The ideal candidate will possess a strong understanding of clinical trial processes, regulatory affairs, and medical terminology. A meticulous approach to documentation and a commitment to quality are paramount. This is an excellent opportunity for a dedicated professional to contribute to the development of life-saving medicines and advance their career in the dynamic pharmaceutical industry. We are looking for an individual who is proactive, detail-oriented, and capable of managing multiple priorities in a challenging yet rewarding environment.
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Clinical Research Associate
Posted 1 day ago
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Key responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits for assigned clinical trial sites.
- Verify the accuracy, completeness, and quality of clinical data by comparing source documents with case report forms (CRFs).
- Ensure compliance with the study protocol, investigational plan, FDA regulations, and Good Clinical Practice (GCP) guidelines.
- Manage and resolve data discrepancies and queries in a timely manner.
- Provide training and ongoing support to site personnel, including investigators and study coordinators.
- Monitor site progress, identify potential issues, and implement corrective actions as needed.
- Maintain essential trial documentation and regulatory files.
- Communicate effectively with study teams, investigators, and relevant stakeholders.
- Prepare visit reports and other necessary documentation.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- Thorough knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in monitoring clinical trials across various therapeutic areas.
- Strong understanding of clinical trial processes and documentation.
- Excellent communication, interpersonal, and problem-solving skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required for monitoring activities.
- Detail-oriented with strong organizational and time management skills.
Clinical Research Associate
Posted 1 day ago
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Job Description
Responsibilities:
- Monitor clinical trial sites to ensure adherence to protocol, GCP guidelines, and regulatory requirements.
- Verify accuracy and completeness of clinical data through source document verification.
- Manage site communications and resolve issues that may arise during the trial.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Ensure proper drug accountability and storage at investigative sites.
- Train study site staff on study procedures and regulatory requirements.
- Prepare monitoring reports and follow up on action items.
- Collaborate with study teams to ensure timely enrollment and data collection.
- Maintain updated knowledge of regulatory requirements and company policies.
- Ensure the safety and rights of study participants are protected.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
- Minimum of 2 years of experience as a Clinical Research Associate or in a similar role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Strong understanding of clinical trial processes and documentation.
- Excellent monitoring and auditing skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Exceptional attention to detail and accuracy.
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- Ability to travel to clinical sites as required.
This role offers a competitive compensation package and the opportunity to contribute to groundbreaking medical research.
Clinical Research Associate
Posted 1 day ago
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Job Description
The successful candidate will possess a strong understanding of clinical trial processes and regulatory requirements within the pharmaceutical industry. You will be adept at identifying and resolving issues that arise during trial conduct, ensuring the integrity of the study data. This position requires excellent organizational skills, attention to detail, and the ability to manage multiple projects simultaneously. The hybrid nature of this role means you will spend a significant portion of your time at clinical trial sites, with the remaining time working remotely. This offers a blend of hands-on site interaction and the flexibility of remote work. You will be expected to travel to sites as needed, typically within the region.
Key responsibilities include conducting pre-study visits, site initiation visits, routine monitoring visits, and close-out visits. You will also be responsible for preparing monitoring reports, maintaining study documentation, and ensuring compliance with all study-related procedures. The ideal candidate will have a Bachelor's degree in a life science, nursing, or related field, with a minimum of 3 years of experience as a CRA or in a similar clinical research role. Knowledge of ICH-GCP guidelines and experience with electronic data capture (EDC) systems are essential. Strong written and verbal communication skills are required, along with proficiency in Microsoft Office Suite. Join our client's dedicated team and contribute to the advancement of life-saving therapies.