23 Regional Cancer Centre jobs in Thiruvananthapuram
Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹700000 Annually
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Posted 3 days ago
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Job Description
Our client is looking for an experienced Clinical Research Associate to be based in Thiruvananthapuram, Kerala, IN . This critical role involves overseeing clinical trials from initiation to close-out, ensuring compliance with protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. The Clinical Research Associate will be instrumental in the successful execution of pharmaceutical research studies, contributing to the development of life-saving treatments. The position requires a meticulous attention to detail, strong organizational skills, and the ability to build effective relationships with study sites and internal stakeholders.
Key Responsibilities:
Key Responsibilities:
- Site selection, initiation, monitoring, and close-out visits.
- Ensuring compliance with study protocols, standard operating procedures (SOPs), and regulatory guidelines (e.g., FDA, ICH GCP).
- Verifying the accuracy and completeness of source documents and case report forms (CRFs).
- Managing study supplies and investigational product at clinical sites.
- Serving as the primary point of contact for investigators and site staff.
- Resolving data discrepancies and ensuring timely query resolution.
- Preparing and submitting regulatory documentation as required.
- Identifying and reporting adverse events and serious adverse events (SAEs) in a timely manner.
- Conducting data reviews and audits to ensure data integrity.
- Maintaining accurate and up-to-date trial documentation in electronic trial master files (eTMF).
- Building and maintaining strong working relationships with study personnel, ethics committees, and regulatory authorities.
- Troubleshooting and resolving site-specific issues to ensure smooth trial conduct.
- Contributing to the development and review of study-related documents, such as protocols and informed consent forms.
- Participating in team meetings and providing regular updates on site progress and challenges.
- Bachelor's degree in a life science, nursing, or a related field. A Master's degree is preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry.
- In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of medical terminology and data management principles.
- Strong organizational and time-management skills, with the ability to manage multiple projects simultaneously.
- Exceptional interpersonal and communication skills, both written and verbal.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites as required.
- A proactive and problem-solving attitude.
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0
Remote Clinical Research Scientist
695001 Thiruvananthapuram, Kerala
₹900000 Annually
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Posted 1 day ago
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Job Description
Our client, a pioneering pharmaceutical company, is seeking an exceptional Remote Clinical Research Scientist to contribute to groundbreaking drug development initiatives. This fully remote position offers the flexibility to work from anywhere within India while collaborating with a world-class team of researchers and clinicians. You will play a pivotal role in the design, execution, and analysis of clinical trials, ensuring adherence to the highest scientific and ethical standards. The ideal candidate will possess a deep understanding of pharmaceutical research, clinical trial methodologies, and regulatory requirements. Your expertise will be instrumental in advancing novel therapies from preclinical stages through to regulatory submission.
Responsibilities:
Responsibilities:
- Design and develop clinical trial protocols, considering scientific rationale, patient populations, and endpoints.
- Oversee the implementation and monitoring of clinical trials, ensuring data integrity and patient safety.
- Analyze and interpret clinical trial data, collaborating with biostatisticians and data management teams.
- Prepare scientific reports, manuscripts for publication, and presentations for internal and external audiences.
- Ensure compliance with Good Clinical Practice (GCP), regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs.
- Provide scientific and technical expertise to cross-functional teams, including regulatory affairs, medical affairs, and marketing.
- Evaluate new drug candidates and therapeutic strategies.
- Stay updated on the latest scientific advancements and emerging trends in relevant therapeutic areas.
- Manage relationships with external investigators, academic institutions, and key opinion leaders.
- Contribute to the strategic planning and pipeline development of the company.
- Ph.D. or M.D. in a relevant life science discipline (e.g., Pharmacology, Biology, Medicine).
- A minimum of 4 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- Proven experience in designing, executing, and analyzing Phase I-IV clinical trials.
- Strong knowledge of drug development processes and regulatory affairs.
- Excellent understanding of biostatistics and data analysis principles.
- Demonstrated ability to publish scientific findings in peer-reviewed journals.
- Exceptional analytical, problem-solving, and critical thinking skills.
- Proficiency in using clinical trial management systems and data analysis software.
- Outstanding written and verbal communication skills, with the ability to present complex scientific information clearly.
- Ability to work independently with minimal supervision in a remote setting and manage multiple projects concurrently.
- A passion for innovation and a commitment to improving patient outcomes.
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1
Senior Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹65000 Annually
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Posted 2 days ago
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Job Description
Our client, a dynamic pharmaceutical company dedicated to advancing healthcare, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their team in Thiruvananthapuram, Kerala, IN . This vital role involves the meticulous monitoring and management of clinical trials to ensure data integrity, patient safety, and adherence to regulatory requirements and protocols. The ideal candidate will possess a strong understanding of clinical trial phases, GCP (Good Clinical Practice) guidelines, and regulatory standards. You will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring that clinical trials are conducted ethically and efficiently. This position requires exceptional organizational skills, strong analytical abilities, and the capacity to build and maintain effective relationships with investigators, study staff, and regulatory agencies.
Key responsibilities include:
Key responsibilities include:
- Performing site selection visits, assessing the suitability of potential clinical trial sites.
- Conducting site initiation visits to train study staff on trial procedures and protocols.
- Monitoring clinical trial sites regularly to ensure compliance with GCP, protocols, and regulatory requirements.
- Verifying the accuracy, completeness, and integrity of clinical data through source data verification.
- Identifying and resolving site-level issues and deviations, implementing corrective and preventive actions.
- Managing investigational product accountability and ensuring proper storage and handling.
- Facilitating communication between study sites, the sponsor, and the ethics committee.
- Ensuring all essential trial documents are accurately maintained at the study site and with the sponsor.
- Participating in study team meetings and providing updates on site performance and status.
- Contributing to the development of clinical trial protocols and case report forms.
- Closing out study sites upon completion of the trial, ensuring all documentation is archived.
- Mentoring and supporting junior CRAs as needed.
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2
Senior Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹1100000 Annually
WhatJobs
Posted 3 days ago
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Job Description
Our client is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their pharmaceutical research team. This role offers a hybrid work arrangement, blending remote flexibility with essential on-site visits for clinical trial monitoring. As a Senior CRA, you will play a pivotal role in ensuring the successful execution of clinical trials by overseeing study sites, monitoring data integrity, and ensuring compliance with regulatory requirements and protocol guidelines. You will be responsible for initiating, monitoring, and closing out clinical trial sites, conducting site visits (both routine and close-out), and verifying source data against case report forms (CRFs). A critical aspect of your role will be to identify, evaluate, and recruit potential investigators and ensure the ethical and scientific integrity of the research conducted. You will also be responsible for training and mentoring site staff, managing study supplies, and addressing protocol deviations and safety issues in a timely manner. The ideal candidate possesses strong analytical, organizational, and communication skills, with a meticulous attention to detail. A bachelor's degree in a life science or health-related field, along with a proven track record as a CRA with extensive experience in clinical trial monitoring, is essential. Experience across multiple therapeutic areas is highly desirable. You must have a thorough understanding of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is required. Your ability to build strong relationships with investigators and site personnel, combined with effective problem-solving skills, will be key to your success. This role is crucial for advancing our drug development pipeline and bringing innovative treatments to patients.
Responsibilities:
Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with protocol and GCP guidelines.
- Ensure the quality and integrity of data collected at clinical trial sites.
- Verify source documentation against case report forms (CRFs).
- Train and mentor investigators and site staff on study protocols and procedures.
- Monitor site compliance with regulatory requirements, ICH guidelines, and study protocols.
- Identify and report adverse events and protocol deviations promptly.
- Manage study supplies and investigational product accountability.
- Build and maintain strong working relationships with investigators, site staff, and study sponsors.
- Prepare monitoring visit reports and follow up on action items.
- Contribute to the development of clinical trial protocols and study documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 4-6 years of experience as a Clinical Research Associate (CRA).
- In-depth knowledge of GCP, ICH guidelines, and FDA regulations.
- Proven experience in monitoring clinical trial sites and ensuring data accuracy.
- Excellent understanding of clinical trial processes and terminology.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional organizational and time management abilities.
- Excellent written and verbal communication skills.
- Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel as required for site visits.
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3
Clinical Research Associate II
695004 Thiruvananthapuram, Kerala
₹70000 Annually
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Posted 3 days ago
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Job Description
Our client is seeking a diligent and detail-oriented Clinical Research Associate II (CRA II) to join their pharmaceutical team in Thiruvananthapuram, Kerala, IN . This role is integral to the successful execution of clinical trials, ensuring adherence to study protocols, regulatory requirements, and ethical standards. The CRA II will be responsible for monitoring clinical trial sites, verifying the accuracy and completeness of data, and ensuring the safety of study participants. This position involves significant travel to clinical sites, requiring strong organizational and time management skills. You will play a critical role in managing relationships with investigators and site staff, providing training on study procedures, and resolving any site-level issues that may arise. A thorough understanding of Good Clinical Practice (GCP) guidelines and regulatory affairs is essential.
Key Responsibilities:
The ideal candidate will hold a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. A Master's degree is a plus. A minimum of 2-4 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring clinical trials, is required. Thorough knowledge of GCP, ICH guidelines, and FDA regulations is essential. Excellent written and verbal communication skills, strong organizational abilities, and meticulous attention to detail are critical. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is highly desirable. The ability to work independently and travel extensively (up to 60-70%) is a requirement for this role.
Key Responsibilities:
- Conduct on-site and remote monitoring visits to clinical trial sites according to the Clinical Monitoring Plan.
- Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure compliance with study protocols, SOPs, GCP, and applicable regulatory requirements.
- Assess the eligibility of potential participants and monitor their progress throughout the trial.
- Provide training and ongoing support to site staff on study-specific procedures and regulatory compliance.
- Manage site relationships, foster open communication, and address any issues or concerns promptly.
- Prepare monitoring visit reports and follow up on action items to ensure resolution.
- Oversee drug accountability and investigational product management at study sites.
- Facilitate site audits and regulatory inspections.
- Contribute to the development of study-related documents, such as protocols and informed consent forms.
- Ensure timely reporting of adverse events and serious adverse events.
- Maintain organized and up-to-date trial master files (TMF).
The ideal candidate will hold a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. A Master's degree is a plus. A minimum of 2-4 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring clinical trials, is required. Thorough knowledge of GCP, ICH guidelines, and FDA regulations is essential. Excellent written and verbal communication skills, strong organizational abilities, and meticulous attention to detail are critical. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is highly desirable. The ability to work independently and travel extensively (up to 60-70%) is a requirement for this role.
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4
Senior Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹90000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced Senior Clinical Research Associate (CRA) to oversee and manage clinical trials within the pharmaceutical sector. This role requires a meticulous and dedicated professional with a strong understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements. The Senior CRA will be responsible for ensuring the quality and integrity of data collected during clinical trials, maintaining accurate study documentation, and ensuring compliance with protocols and regulatory standards. You will play a critical role in site selection, initiation, monitoring, and close-out activities, working closely with investigators, site staff, and internal project teams. The position involves frequent site visits to assess protocol adherence, patient safety, and data accuracy. This is a hybrid role, offering a blend of on-site responsibilities at our facilities in Thiruvananthapuram, Kerala , and remote work flexibility. You will be expected to manage multiple trial sites simultaneously, ensuring that all activities are conducted according to plan and that any issues are promptly identified and resolved. Building strong relationships with site personnel is paramount to the success of the trials. The ideal candidate will possess excellent communication, organizational, and problem-solving skills. A proactive approach to identifying and mitigating risks is essential. This role offers a challenging and rewarding opportunity to contribute to the development of life-saving pharmaceuticals.
Responsibilities:
Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits.
- Ensure compliance with study protocols, GCP, and regulatory requirements.
- Verify the accuracy and completeness of clinical trial data.
- Manage investigational product accountability and drug dispensing.
- Train and educate site staff on study procedures.
- Resolve site-specific issues and ensure timely resolution of queries.
- Maintain essential study documents and records.
- Prepare monitoring visit reports and action items.
- Communicate effectively with investigators, site staff, and the internal project team.
- Bachelor's degree in a life science, nursing, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent organizational, time management, and communication skills.
- Ability to travel to clinical trial sites.
- Proficiency in clinical trial management software.
This advertiser has chosen not to accept applicants from your region.
5
Remote Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹70000 Monthly
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking a dedicated and experienced Remote Clinical Research Associate (CRA) to join their pioneering pharmaceutical research team. This fully remote position offers the opportunity to contribute to groundbreaking drug development from the comfort of your own home, supporting studies across various therapeutic areas. As a remote CRA, you will be responsible for monitoring clinical trials to ensure adherence to protocols, good clinical practices (GCP), and regulatory requirements. Your primary focus will be on site management, data integrity, and patient safety. This role involves extensive communication with clinical sites, investigators, and internal stakeholders, all conducted virtually. You will conduct remote site initiation visits, monitoring visits (potentially with some on-site visits as required by specific protocols, but the role is predominantly remote), and close-out visits. Key responsibilities include reviewing and verifying source documents against case report forms (CRFs), tracking and resolving data queries, ensuring timely submission of study-related documents, and managing investigational product accountability. You will also be responsible for identifying and reporting adverse events and deviations. We are looking for individuals with meticulous attention to detail, strong organizational skills, and the ability to work autonomously. Excellent interpersonal and communication skills are paramount, given the remote nature of the role, as you will be building and maintaining relationships with research professionals across different locations. This position requires a deep understanding of clinical trial processes and pharmaceutical regulations. The ability to manage your time effectively and meet strict deadlines is critical for success. Join a forward-thinking company that values innovation and is committed to improving global health through cutting-edge pharmaceutical research.
Qualifications:
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in remote monitoring and site management.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently with minimal supervision and manage multiple priorities.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong analytical and problem-solving abilities.
- Detail-oriented with a commitment to accuracy and quality.
- Willingness to travel for essential on-site visits if required by specific study protocols (though the role is predominantly remote).
- A proactive approach to identifying and resolving study-related issues.
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Senior Clinical Research Scientist
695004 Thiruvananthapuram, Kerala
₹1100000 Annually
WhatJobs
Posted 3 days ago
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Job Description
Our client, a prominent pharmaceutical company, is seeking an experienced Senior Clinical Research Scientist to spearhead critical research initiatives. This role is instrumental in designing, implementing, and overseeing clinical trials that drive the development of innovative therapeutic solutions. The ideal candidate will possess a strong scientific background, extensive experience in clinical trial methodologies, and a deep understanding of regulatory requirements within the pharmaceutical industry. You will be responsible for developing clinical study protocols, managing trial execution, and interpreting complex scientific data to assess drug efficacy and safety. Collaboration with cross-functional teams, including medical affairs, regulatory affairs, biostatistics, and data management, is crucial. Key responsibilities include identifying research opportunities, designing study endpoints, selecting appropriate investigational sites, and ensuring adherence to Good Clinical Practice (GCP) guidelines. You will play a vital role in the scientific review of clinical data, authoring study reports, and contributing to regulatory submissions. This hybrid position balances the need for collaborative in-office engagement with the flexibility of remote work, allowing for focused research and effective team interaction. We are looking for a highly analytical, detail-oriented individual with exceptional scientific acumen and a passion for advancing patient care through groundbreaking pharmaceutical research. A strong publication record and experience presenting at scientific conferences are highly valued. A Ph.D. or Master's degree in a life science discipline, combined with substantial experience in clinical drug development, is required.
Responsibilities:
Responsibilities:
- Design and develop clinical trial protocols, including study objectives, endpoints, and statistical plans.
- Oversee the execution of clinical trials, ensuring compliance with GCP and regulatory guidelines.
- Manage relationships with investigational sites, Contract Research Organizations (CROs), and other external partners.
- Interpret and analyze complex clinical data, identifying trends and drawing scientifically sound conclusions.
- Author clinical study reports, manuscripts for publication, and regulatory submission documents.
- Collaborate with cross-functional teams, including medical monitors, statisticians, and regulatory experts.
- Contribute to the scientific strategy and pipeline development for new drug candidates.
- Present scientific findings at internal meetings and external conferences.
- Stay abreast of scientific advancements, therapeutic areas, and competitor activities.
- Ensure the safety and well-being of study participants throughout the trial process.
- Ph.D. or Master's degree in a Life Science discipline (e.g., Pharmacology, Biology, Biochemistry, Medicine).
- Minimum of 5-7 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- Proven experience in clinical trial design, execution, and data analysis.
- In-depth knowledge of Good Clinical Practice (GCP) and regulatory requirements (e.g., FDA, EMA).
- Strong scientific writing and communication skills, with a track record of publications and presentations.
- Experience with statistical analysis and interpretation of clinical data.
- Ability to work effectively in a hybrid work environment and collaborate with diverse teams.
- Excellent project management and organizational skills.
- Demonstrated ability to critically evaluate scientific literature and data.
- Experience in specific therapeutic areas relevant to the company's pipeline is a plus.
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7
Clinical Research Associate (Pharmaceutical)
695001 Thiruvananthapuram, Kerala
₹70000 Monthly
WhatJobs
Posted 3 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a diligent and experienced Clinical Research Associate (CRA) to contribute to vital drug development programs. This hybrid role offers a blend of remote work flexibility and necessary on-site responsibilities for site visits and essential team meetings. You will be instrumental in monitoring clinical trials, ensuring they are conducted, recorded, and reported in accordance with the study protocol, standard operating procedures (SOPs), and applicable regulatory requirements. Your responsibilities will include site initiation visits, routine monitoring, and close-out visits to investigational sites. You will verify the accuracy and completeness of clinical data, manage source documentation, and ensure the safety of study participants. Building and maintaining strong relationships with investigators and site staff is a key aspect of this role. The CRA will also be responsible for ensuring compliance with Good Clinical Practice (GCP) guidelines and all relevant regulatory guidelines. Travel to clinical trial sites across the region will be required. The ideal candidate will possess a Bachelor's or Master's degree in a life science, nursing, or related field, along with proven experience as a Clinical Research Associate. A thorough understanding of clinical trial processes, regulatory requirements, and data management is essential. Excellent communication, organizational, and problem-solving skills are required. The ability to manage multiple tasks and prioritize effectively is crucial. This is an exciting opportunity to join a dynamic pharmaceutical team and play a critical role in bringing life-changing medicines to patients. The role is based in Thiruvananthapuram, Kerala, IN , with a hybrid work arrangement.
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8
Senior Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹900000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is looking for a dedicated and experienced Senior Clinical Research Associate (CRA) to join their team based in Thiruvananthapuram, Kerala . This critical role involves overseeing and managing clinical trials to ensure data accuracy, patient safety, and adherence to regulatory guidelines and protocols. As a Senior CRA, you will be responsible for site selection, initiation, monitoring, and close-out visits. You will conduct regular site visits to assess protocol compliance, review case report forms (CRFs), query data discrepancies, and ensure the proper investigational product accountability. Building and maintaining strong relationships with investigators, site staff, and study participants is paramount. You will also be responsible for identifying and resolving site issues, providing training to site personnel, and ensuring that all trial-related documentation is maintained accurately and efficiently. The ideal candidate will have a solid understanding of Good Clinical Practice (GCP) guidelines, relevant regulatory requirements (e.g., FDA, EMA), and clinical trial processes. Excellent organizational, time-management, and problem-solving skills are essential, along with strong written and verbal communication abilities. Previous experience as a CRA, with a significant portion at a senior level, is required. Experience in specific therapeutic areas may be advantageous. This position requires frequent travel to clinical trial sites within the assigned region. The successful candidate will play a crucial role in advancing our client's drug development pipeline and contributing to the delivery of life-changing therapies. We are committed to fostering a supportive and growth-oriented work environment, offering opportunities for professional development and career advancement within the pharmaceutical industry.
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