Clinical Research Coordinator
The Clinical Research Coordinator supports the Research Department by facilitating subject recruitment, managing data workflows, and coordinating the collection and processing of biological specimens and study-related documentation.
Responsibilities
- Organize research files, projects, and data to support study operations.
- Collect, process, and verify research data, samples, and specimens in accordance with study protocols.
- Enter and maintain accurate data in databases and study documents.
- Perform routine data quality checks to ensure protocol compliance and data integrity.
- Review and adhere to standard operating procedures (SOPs) and study protocols.
- Notify referring physicians of patient study participation per patient request.
- Collect, process, and ship blood, urine, and stool specimens during patient visits.
- Complete and audit case report forms (CRFs) per FDA guidelines, ensuring alignment with medical records.
- Submit patient stipends and reimbursement requests post-visit.
- Maintain regulatory documentation and ensure proper filing.
- Monitor and log specimen storage temperatures.
- Order and distribute dry ice as needed.
- Track expiration dates on clinical supplies and reorder as necessary.
- Assist with preparation of source documents and study materials.
- Support subject recruitment through chart reviews, outreach, and scheduling.
- Process lab specimens and assist with vital signs collection.
- Perform Fibroscans and phlebotomy once trained.
- Provide general administrative support to ensure smooth departmental operations.
- Perform other duties as assigned.
Minimum Qualifications
Bachelors degree (or four years of relevant clinical research experience in lieu of degree).At least two years of experience in a healthcare-related role.Prior experience conducting clinical trials required; pharmaceutical trial experience preferred.Preferred Qualifications
Strong verbal and written communication skills; able to present information clearly to physicians, staff, and patients.Proficiency in Microsoft Office; familiarity with EMR systems required.Demonstrated ability to work collaboratively in a team environment.Critical thinking and problem-solving skills.High attention to detail and professional conduct.Completion of Good Clinical Practice (GCP) and IATA training.Flexibility to work variable hours as needed.Phlebotomy experience preferred.Self-motivated with a strong willingness to learn and take initiative.