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Job Brief
We are seeking a highly organized and detail-oriented Clinical Research Coordinator to oversee the planning and implementation of clinical trials. A Clinical Research Coordinator is responsible for managing and coordinating all aspects of clinical trials. The ideal candidate will manage trial operations, ensure compliance with regulatory standards, and coordinate with clinical sites to facilitate successful research outcomes.
Responsibilities
- Oversee daily operations of clinical trials, including site management, participant recruitment, and data collection.
- Ensure compliance with study protocols and regulatory requirements by working closely with clinical sites.
- Monitor trial progress to adhere to regulatory guidelines, Good Clinical Practice (GCP), and institutional policies.
- Develop and maintain study-related documents, including protocols, consent forms, and reports.
- Identify, screen, and enroll participants, manage consent processes, and document participant information accurately.
- Oversee data collection, ensuring accuracy and addressing discrepancies or issues.
- Train site staff on study procedures and protocols, ensuring proper implementation.
- Resolve any issues or challenges that arise during the trial.
- Keep detailed records of study activities, including case report forms, drug dispensation records, and other regulatory forms.
- Manage inventory of equipment and supplies, ensuring all are in stock and in good working order.
Requirements and Skills
- Understanding of biochemistry, pharmacology, and chemistry to make informed decisions.
- Strong analytical skills for data collection, interpretation, and identifying patterns.
- In-depth knowledge of the research process, including trial setup and data management.
- Ability to communicate effectively with researchers, participants, and stakeholders.
- Exceptional written and verbal communication skills for reporting and liaising with staff.
- Outstanding organizational skills to manage complex trials, participants, and data.
- At least 1 year of experience working in a clinical setting.
- Skilled in standard computer programs, including MS Office, and understanding of medical terminology.
- Prior experience in training and mentoring staff is preferred.
- Ability to lift up to 20 pounds and stand for extended periods as needed.
Frequently Asked Questions
What does a Clinical Research Coordinator do?
A Clinical Research Coordinator oversees trial operations, manages participant recruitment, ensures compliance with regulatory guidelines, and handles data collection and reporting.
What should you look for in a Clinical Research Coordinator resume?
When reviewing a Clinical Research Coordinator resume, consider:
- Relevant Experience: Look for previous experience in clinical research, including specific roles and responsibilities.
- Knowledge of Regulations and Guidelines: Ensure familiarity with regulatory guidelines such as Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements.
- Documentation and Record-Keeping Skills: Check for experience in developing and maintaining study-related documents, such as protocols, consent forms, and reports.
- Data Management Skills: Experience with data collection, data entry, and ensuring data accuracy.