2,662 Clinical Research jobs in India

• Design and implement clinical trial protocols.
• Oversee data collection, management, and analysis for clinical studies.
• Ensure compliance with GCP, FDA, and other regulatory requirements.
• Collaborate with internal teams and external partners, including investigators and CROs.
• Interpret clinical data and prepare study reports and manuscripts.
• Contribute to the development of regulatory submissions (e.g., IND, NDA).
• Provide scientific and technical expertise to project teams.
• Monitor trial progress and identify/mitigate risks.

• Ph.D. or Master's degree in Life Sciences, Pharmacology, Pharmacy, or a related field.
• Minimum of 5 years of experience in clinical research within the pharmaceutical or biotech industry.
• Proven track record in designing and managing clinical trials.
• Strong knowledge of regulatory guidelines (ICH, GCP).
• Expertise in statistical analysis software (e.g., SAS, R) and data visualization tools.
• Excellent written and verbal communication skills, with the ability to present complex data clearly.
• Ability to work independently and manage projects effectively in a remote setting.

• Lead the design and development of clinical trial protocols for oncology indications, ensuring scientific rigor and alignment with regulatory requirements.
• Provide scientific and medical expertise throughout the clinical trial lifecycle, from protocol concept to final study report.
• Collaborate with investigators, study coordinators, and other clinical personnel to ensure proper trial conduct and data integrity.
• Analyze and interpret complex clinical data, including efficacy and safety endpoints, to inform decision-making.
• Develop scientific publications, abstracts, and presentations based on clinical trial data for peer-reviewed journals and scientific congresses.
• Provide input on the selection of biomarkers and endpoints for clinical studies.
• Stay current with the latest scientific advancements, clinical data, and regulatory guidelines in oncology drug development.
• Contribute to the strategic planning of the oncology pipeline and therapeutic area development.
• Mentor and guide junior scientists and research associates.

• Ph.D. or M.D. in a relevant life science or medical discipline (e.g., Oncology, Pharmacology, Medicine).
• Minimum of 7 years of progressive experience in clinical research, with a significant focus on oncology clinical trials.
• Extensive knowledge of clinical trial design, execution, and data analysis principles.
• Demonstrated experience in developing clinical protocols and managing the operational aspects of trials.
• Strong understanding of cancer biology, therapeutic mechanisms, and current treatment landscapes.
• Excellent scientific writing and communication skills, with a proven ability to publish research findings.
• Familiarity with regulatory guidelines (e.g., ICH-GCP, FDA, EMA) related to clinical trials.
• Ability to critically evaluate scientific literature and data.
• Proven ability to collaborate effectively in a remote, cross-functional team environment.

Job Role : Clinical Research Associate - Study Personnel (Toxicology & Efficacy)

Location: Dholka, Gujarat

Job Responsibilities :

1. Request for required no. of animals

2. Observe the study animals for clinical signs, functional observation battery and

mortality

3. Receipt, storage and handling of chemicals, reagents and solutions

4. Dose preparation and dosing of animals via different routs

5. Weighing of animals, feed consumption, body temperature, dermal observations

6. Randomization of study animals

7. Perform pharma-efficacy studies like batch release test i.e., Pyrogen test, Abnormal

toxicity test, Potency assays, nodule test etc.

8. Blood collection, separation and storage of samples

9. Preparation of study reports

10. Conduct of study, data collection, compilation and verification.

11. Collection of sample(s) / Specimen(s).

12. Preparation and verification of report.

13. To participate in Genotoxicity study

14. Data entry from raw data to computer application and further analysis

15. Co-operate during internal, RQA & sponsor audits of study plans, studies, data,

reports etc.

16. To participate in standardization of new toxicity study

17. Ensure proper labeling of containers (test item, samples etc.)

Documentation:

1. To document deviation from SOP or study plan and communicate directly with SD.

2. Recording raw data promptly and accurately and in compliance with Principles of

GLP.

3. Maintenance of internal records as per in-house SOPs and GLP

4. Update and maintain training records

5. Ensuring the availability of various monitoring certificates such as feed, water,

bedding material, health etc.

6. Request for the issuance of controlled / uncontrolled document and maintain the

documentation

7. Prepare / revise the SOPs as and when required in accordance with in-house SOP

8. Archive the documents as per in-house SOPs when applicable

9. Document the deviation from study plan or SOP and report the incident to SD or

HOS.

10. Record the raw data as and when activities are performed, verify the data and

calculation.

11. Results compilation and analysis

Instrument handling and maintenance:

1. Operate the instruments in accordance with respective instrument SOP, monitor

calibration & maintenance of instrumentation in lab

2. Perform the calibration / maintenance of instruments as per in-house SOP

• 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.

• 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.

• 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.

• 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.