Clinical Research Co-ordinator

Key Responsibilities:

• Study Planning & Preparation:
• Assist in the development of study protocols, informed consent documents, and other study-related documents.
• Collaborate with Principal Investigators (PIs) and other clinical staff to ensure the research study is ready for initiation.
• Ensure that all study materials (e.g., consent forms, case report forms) are organized and accessible.
• Participant Recruitment & Retention:
• Recruit, screen, and enroll study participants based on inclusion/exclusion criteria.
• Maintain clear communication with participants throughout the study.
• Provide participants with detailed study information and obtain informed consent.
• Address any participant concerns and ensure compliance with study procedures.
• Data Collection & Management:
• Collect, record, and maintain accurate clinical data as per study protocols.
• Monitor the progress of the study, ensuring accurate data collection and documentation.
• Handle study samples (e.g., blood, urine) and ensure proper storage and transport as required.
• Maintain study-related records in accordance with Good Clinical Practice (GCP) and regulatory standards.
• Regulatory Compliance:
• Ensure that the study complies with all regulatory requirements, including those set forth by the FDA, IRBs, and other governing bodies.
• Prepare and submit regulatory documents to IRBs (Institutional Review Boards) and other regulatory agencies.
• Monitor participant safety and report any adverse events to the PI and regulatory bodies.
• Keep up-to-date with changes in clinical research regulations and guidelines.
• Study Monitoring & Reporting:
• Perform regular monitoring of the clinical trial to ensure compliance with the protocol.
• Report study progress and findings to the Principal Investigator and other stakeholders.
• Ensure that all study milestones and deadlines are met.
• Organize and participate in study meetings and site visits.
• Budget & Resource Management:
• Assist with the management of study budgets, including coordinating the ordering of study supplies and ensuring costs stay within the allocated budget.
• Ensure proper equipment and resources are available for study procedures.
• Safety Monitoring:
• Ensure that participant safety is monitored throughout the trial.
• Report and document any adverse events or unanticipated problems to the appropriate authorities.
• Training & Support:
• Provide training and guidance to junior staff or new coordinators.
• Support clinical trial staff with any operational challenges or questions.

Qualifications:

• Education: Bachelor’s degree in a relevant field (e.g., Life Sciences, Nursing, Healthcare)
• Skills:
• Strong organizational and time-management skills.
• Excellent written and verbal communication.
• Ability to work independently as well as part of a team.
• Knowledge of clinical trial management software (e.g., EDC, CTMS).
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Working Conditions:

• Location: Clinical research sites, hospitals, academic medical centers, or offices.
• Hours: Typically full-time; may involve evening or weekend work depending on study needs.
• Travel: May require occasional travel to other study sites or regulatory meetings.

Key Attributes:

• Detail-oriented and thorough.
• Able to work under pressure and meet deadlines.
• Strong ethical standards and a commitment to participant welfare.

Job Types: Full-time, Permanent

Pay: ₹30,086.00 - ₹40,006.71 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person