Clinical Research Associate

Why This Role Matters
The Clinical Research Associate / Site Coordinator plays a vital role in supporting clinical trials by managing site feasibility, documentation, patient recruitment, and regulatory compliance. By ensuring timely submissions, accurate data collection, and proper site and patient management, this role contributes to the successful execution of clinical studies and the generation of high-quality data for research and regulatory submissions.

Job Description
The Clinical Research Associate / Site Coordinator will assist Principal Investigators (PI) and Co-Investigators (Co-I) in all aspects of clinical trial management, including site feasibility, pretrial documentation, IRB submissions, site initiation, patient recruitment, CRF completion, and drug accountability. The role also involves coordinating follow-up visits, maintaining site and patient files, supporting safety reporting, and managing financial responsibilities related to the study.

Key Features Of The Role
• Assist PI in completing site feasibility for newly proposed trials/studies
• Collect updated and signed resumes of all site team members
• Ensure timely completion of pretrial documentation including Financial Disclosure Forms, PI Undertakings, Confidentiality/Non-Disclosure Agreements, and Data Confidentiality Forms
• Actively follow up with IRB for trial approvals and timely submission of safety reports and amendments
• Prepare for and participate in site initiation visits
• Maintain site files, patient files, and screening logs
• Pre-screen, screen, enroll, and recruit subjects for studies/trials
• Create and prepare source documents and templates
• Complete Case Report Forms (CRFs) and data entry accurately
• Conduct investigator, sponsor, and patient meetings for the trial
• Coordinate and schedule subject follow-up visits physically or telephonically
• Manage drug accountability and related documentation
• Maintain financial records including budget sheets, IRB fees, site administration fees, laboratory costs, and study subject reimbursements

Responsibilities
• Assist in site feasibility assessments and prepare reports for newly proposed studies
• Collect and verify resumes and credentials of site staff
• Ensure all pretrial documentation is completed within specified timelines
• Follow up with IRB to ensure timely trial approval and submission of amendments and safety reports
• Prepare for site initiation visits and assist PI/Co-I during the process
• Maintain comprehensive site files and patient files with accurate documentation
• Pre-screen, screen, enroll, and recruit study subjects according to protocol
• Prepare source documents and templates for study data collection
• Complete CRFs and ensure accurate data entry
• Organize and conduct investigator, sponsor, and patient meetings
• Coordinate regular/follow-up visits for subjects
• Monitor and document drug accountability
• Maintain financial records for IRB fees, site administration fees, laboratory costs, and subject reimbursements

Required Qualifications

Educational Requirements
• Bachelor of Science (B.Sc)
• Master of Science (M.Sc) preferred

Experience And Skills
• 0–5 years of experience in clinical research, site coordination, or related field
• Knowledge of clinical trial protocols, IRB submissions, and regulatory requirements
• Experience in patient recruitment, CRF completion, and data management
• Strong organizational, documentation, and time-management skills
• Attention to detail and ability to maintain accurate records
• Good communication and interpersonal skills for coordinating with PIs, sponsors, and patients

Salary Insights
• Compensation as per company norms and industry standards
• Opportunities for career growth in clinical research and trial management
• Exposure to all aspects of site management, regulatory compliance, and patient coordination

Company Overview
The organization is a leading clinical research institute focused on delivering high-quality patient care and clinical trial management. It emphasizes regulatory compliance, accurate data collection, and scientific rigor, providing staff with opportunities for professional growth and development in clinical research.

FAQs
Q: What are the main responsibilities of this role?
A: Site feasibility, pretrial documentation, IRB submissions, site initiation, patient recruitment, CRF completion, drug accountability, and financial management.

Q: What qualifications are required?
A: B.Sc is required; M.Sc is preferred.

Q: Is experience in clinical trials necessary?
A: Yes, 0–5 years of experience in clinical research or site coordination is preferred.

Application Tips
• Highlight any experience in clinical trial management, site coordination, or patient recruitment
• Emphasize knowledge of IRB submissions, CRF completion, and regulatory compliance
• Showcase organizational skills and attention to detail
• Include experience managing site files, patient files, and drug accountability