7 Regional Cancer Centre jobs in Thiruvananthapuram
Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹700000 Annually
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Posted 4 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
Senior Clinical Research Scientist
695004 Thiruvananthapuram, Kerala
₹1100000 Annually
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Posted today
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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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1
Clinical Research Associate (Pharmaceutical)
695001 Thiruvananthapuram, Kerala
₹70000 month
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Posted 2 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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2
Senior Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹900000 Annually
WhatJobs
Posted 4 days ago
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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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3
Senior Clinical Research Associate
695001 Thiruvananthapuram, Kerala
₹780000 Annually
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Posted 4 days ago
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Job Description
Our client is looking for a dedicated and detail-oriented Senior Clinical Research Associate (CRA) to join their growing pharmaceutical team. This role is crucial in ensuring the successful execution of clinical trials in compliance with regulatory standards and protocols. The position offers a hybrid work arrangement, combining remote flexibility with essential on-site responsibilities in Thiruvananthapuram, Kerala, IN . The ideal candidate will have a strong background in clinical research, excellent organizational skills, and a commitment to ethical scientific practices.
Responsibilities:
Responsibilities:
- Conduct site selection visits to assess the suitability of potential clinical trial sites.
- Initiate, monitor, and close-out clinical trial sites according to Good Clinical Practice (GCP) guidelines and protocol requirements.
- Ensure accurate and timely collection of clinical data, verifying source documentation against case report forms (CRFs).
- Manage investigational product accountability at trial sites.
- Oversee patient recruitment and retention efforts at study sites.
- Train site personnel on study protocols, procedures, and regulatory requirements.
- Serve as the primary point of contact between the sponsor and study sites.
- Ensure compliance with all applicable regulatory requirements, including those of the Indian regulatory authorities.
- Identify and report adverse events and serious adverse events promptly.
- Prepare and submit monitoring visit reports in a timely manner.
- Participate in Investigator Meetings and other relevant site meetings.
- Build and maintain strong relationships with investigators and site staff.
- Contribute to the development of study protocols and clinical trial plans.
- Ensure all study-related documentation is maintained in compliance with GCP and company SOPs.
- Perform risk-based monitoring activities to identify and mitigate potential issues.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 5 years of experience as a Clinical Research Associate or in a similar clinical research role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials in India.
- Proven experience in monitoring multiple clinical trials across different therapeutic areas.
- Excellent understanding of pharmaceutical drug development process.
- Strong communication, interpersonal, and negotiation skills.
- Ability to manage time effectively and prioritize tasks in a dynamic environment.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel extensively to clinical trial sites as required by the hybrid model.
- Strong attention to detail and organizational skills.
- Familiarity with data analysis and interpretation for clinical studies is an advantage.
- Experience within the pharmaceutical sector, particularly in the development of novel therapeutics, is preferred for opportunities in Thiruvananthapuram, Kerala, IN .
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4
Clinical Research Associate (CRA)
695001 Thiruvananthapuram, Kerala
₹75000 Annually
WhatJobs
Posted 4 days ago
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Job Description
Our client is seeking a diligent and experienced Clinical Research Associate (CRA) to join their esteemed pharmaceutical research team in Thiruvananthapuram, Kerala . This role is integral to the successful execution of clinical trials, ensuring adherence to protocols, regulations, and ethical standards. The CRA will be responsible for site monitoring, data verification, and ensuring the safety and well-being of study participants.
The ideal candidate will have a strong understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements. Responsibilities include selecting, training, and supporting study sites, conducting site visits (both remote and on-site), monitoring trial progress, ensuring data accuracy, and managing essential study documents. You will act as a key liaison between the sponsor and the clinical trial sites, fostering positive relationships and facilitating effective communication. This role demands excellent organizational skills, attention to detail, and the ability to work both independently and as part of a collaborative team. A proactive approach to problem-solving and a commitment to maintaining the highest standards of research integrity are essential.
Key Responsibilities:
Qualifications:
The ideal candidate will have a strong understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements. Responsibilities include selecting, training, and supporting study sites, conducting site visits (both remote and on-site), monitoring trial progress, ensuring data accuracy, and managing essential study documents. You will act as a key liaison between the sponsor and the clinical trial sites, fostering positive relationships and facilitating effective communication. This role demands excellent organizational skills, attention to detail, and the ability to work both independently and as part of a collaborative team. A proactive approach to problem-solving and a commitment to maintaining the highest standards of research integrity are essential.
Key Responsibilities:
- Select, initiate, monitor, and close-out investigational sites participating in clinical trials.
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
- Monitor study conduct through regular site visits (remote and on-site) to verify data accuracy and completeness.
- Verify source documentation against case report forms (CRFs).
- Oversee drug accountability and management at study sites.
- Ensure timely reporting of adverse events and safety information.
- Act as the primary point of contact for study sites and communicate effectively with investigators and site staff.
- Manage essential regulatory documents and ensure their completeness and accuracy.
- Identify and report potential risks and issues to the Clinical Trial Manager.
- Contribute to study-related documentation and reporting.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or related field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience in site monitoring and data verification.
- Excellent organizational, time management, and problem-solving skills.
- Strong interpersonal and communication skills, with the ability to build rapport with site personnel.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel as required (up to 40-50% for on-site visits).
- Detail-oriented with a commitment to accuracy and integrity.
- Valid driver's license and clean driving record.
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5
Remote Clinical Research Associate - Pharmaceuticals
695001 Thiruvananthapuram, Kerala
₹90000 Annually
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Posted today
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Job Description
Our client, a leading pharmaceutical organization, is seeking a highly skilled and motivated Clinical Research Associate (CRA) to join their innovative team. This is a fully remote position, offering an excellent opportunity for experienced CRAs to manage their clinical trials from anywhere in India. The successful candidate will be responsible for monitoring and managing clinical trial sites, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will conduct site visits (remote or in-person as needed), train site personnel, resolve data discrepancies, and ensure the quality and integrity of clinical trial data. This role requires a strong understanding of drug development processes, clinical trial methodologies, and a keen eye for detail. You will serve as the primary point of contact between the sponsor and the investigative sites. The ability to build strong relationships with investigators and site staff is crucial for success. You will be involved in all phases of the clinical trial lifecycle, from site selection and initiation to close-out. Key responsibilities include reviewing source documents, monitoring patient safety, and ensuring timely completion of trial-related activities. This position demands excellent analytical and problem-solving skills, as well as superior written and verbal communication abilities. A commitment to ethical research conduct and patient well-being is paramount. The ideal candidate will be proactive, organized, and capable of working independently with minimal supervision. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is essential. This remote role requires robust self-discipline and effective virtual collaboration skills.
Responsibilities:
Qualifications:
Responsibilities:
- Monitor assigned clinical trial sites to ensure adherence to protocol, GCP, and regulatory requirements.
- Perform site initiation, monitoring, and close-out visits.
- Train and support site staff on study-specific procedures and regulatory compliance.
- Review and verify clinical data for accuracy, completeness, and consistency.
- Identify, document, and resolve site-related issues and deviations.
- Ensure patient safety and adherence to study protocols.
- Act as the main liaison between the sponsor and investigative sites.
- Manage essential documents and ensure regulatory compliance at the site level.
- Contribute to the development and review of study-related documents.
- Prepare and present monitoring reports.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP guidelines and regulatory requirements.
- Experience with various therapeutic areas is a plus.
- Proficiency in CTMS and EDC systems.
- Excellent written and verbal communication skills.
- Strong organizational and problem-solving abilities.
- Ability to travel as needed for monitoring visits (though the role is primarily remote).
- Demonstrated ability to work independently and manage time effectively.
- Proven experience in remote work environments.
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