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Kimberly Kelly
Clinical Research Coordinator
Summary
Experienced Clinical Research Coordinator with a proven track record of success in managing and coordinating clinical trials. Demonstrated expertise in protocol development, regulatory affairs, data management, patient recruitment and retention, and Good Clinical Practice (GCP). Proficient in managing multiple projects simultaneously and working effectively in a fast-paced environment.
Education
Bachelor’s Degree in Life Sciences
May 2018
Skills
- Protocol Development
- Clinical Trial Management
- Regulatory Affairs
- Data Management
- Patient Recruitment and Retention
- Good Clinical Practice (GCP)
Work Experience
Clinical Research Coordinator
- Monitored patient safety and collected, analyzed, and summarized clinical data for regulatory submissions and publications.
- Conducted site audits and monitored compliance with Good Clinical Practice (GCP) regulations.
- Provided regulatory guidance and support to investigators and study teams.
- Managed vendor relationships and ensured timely delivery of study materials.
Clinical Research Coordinator
- Coordinated and managed Phase III clinical trial for a novel cancer therapy, involving 500+ patients at 15+ sites.
- Developed and implemented studyspecific Standard Operating Procedures (SOPs) and protocols, ensuring compliance with regulatory guidelines (ICHGCP, FDA, EMA).
- Managed patient recruitment, screening, and enrollment processes, exceeding targets by 15%.
- Collaborated with Principal Investigators and study team to design and execute clinical trial protocols.
Accomplishments
- Managed a team of 10 research coordinators, ensuring efficient and compliant conduct of multiple clinical trials.
- Successfully coordinated a Phase III clinical trial with over 500 participants, meeting all regulatory and ethical requirements.
- Developed and implemented a quality assurance program that significantly reduced errors in clinical trial data collection.
- Collaborated with investigators and sponsors to design and conduct clinical trials that met scientific and regulatory standards.
- Mentored junior research coordinators, providing guidance and support in their professional development.
Awards
- Recipient of the Clinical Research Excellence Award for outstanding contributions to clinical research coordination.
- Recognized with the Clinical Research Innovation Award for developing and implementing a novel data management system.
- Awarded the Clinical Research Leadership Award for fostering a collaborative and supportive research environment.
Certificates
- Certified Clinical Research Coordinator (CCRC)
- Certified Associate in Clinical Research (CACR)
- ICH-GCP Certificate
- HIPAA Certification
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Essential Experience Highlights for a Strong Clinical Research Coordinator Resume
- Coordinate and manage clinical trials from start-up to closeout, including protocol development, patient recruitment, data collection, and regulatory compliance.
- Develop and implement Standard Operating Procedures (SOPs) and protocols to ensure compliance with regulatory guidelines.
- Manage patient recruitment, screening, and enrollment processes to achieve target enrollment goals.
- Collaborate with Principal Investigators and study team to design and execute clinical trial protocols.
- Monitor patient safety and collect, analyze, and summarize clinical data for regulatory submissions and publications.
- Conduct site audits and monitor compliance with Good Clinical Practice (GCP) regulations.
- Provide regulatory guidance and support to investigators and study teams.
Frequently Asked Questions (FAQ’s) For Clinical Research Coordinator
What are the key skills required for a Clinical Research Coordinator?
Key skills for a Clinical Research Coordinator include protocol development, clinical trial management, regulatory affairs, data management, patient recruitment and retention, and Good Clinical Practice (GCP).
What is the job outlook for Clinical Research Coordinators?
The job outlook for Clinical Research Coordinators is expected to be good over the next few years. The increasing number of clinical trials being conducted is expected to drive demand for qualified professionals.
What is the average salary for a Clinical Research Coordinator?
The average salary for a Clinical Research Coordinator in the United States is around $75,000 per year.
What are the career advancement opportunities for Clinical Research Coordinators?
Clinical Research Coordinators can advance their careers by becoming Clinical Research Managers or Clinical Trial Managers. They can also move into other areas of clinical research, such as regulatory affairs or data management.
What are the most common challenges faced by Clinical Research Coordinators?
The most common challenges faced by Clinical Research Coordinators include patient recruitment, regulatory compliance, and data management.
What are the top companies that hire Clinical Research Coordinators?
Top companies that hire Clinical Research Coordinators include Pfizer, Roche, and Novartis.
What is the difference between a Clinical Research Coordinator and a Clinical Trial Manager?
Clinical Research Coordinators are responsible for the day-to-day management of clinical trials, while Clinical Trial Managers are responsible for the overall planning and execution of clinical trials.