Job Summary
The Salisbury Foundation for Research and Education is looking for a full-time Research Study Coordinator to work on clinical research studies. The position also involves study recruitment, data management, data collection, monitoring and reporting adverse events, conducting study assessment visits, preparing reports for study sponsors, development of SOPs, biospecimen processing, preparation of IRB and regulatory paperwork, compilation and documentation of data, and management of projects. The Research Study Coordinator will assist with other research related activities as needed.
Candidate must be available to work in-person Monday-Friday. This position is located in Salisbury, North Carolina.
Duties
- Coordinate all aspects of clinical trials, including participant recruitment, scheduling, and follow-up visits, ensuring smooth study operations.
- Review and verify study documentation for accuracy, completeness, and compliance with FDA regulations, ICH GCP guidelines, and institutional policies.
- Monitor patient progress by collecting vital signs, blood samples through phlebotomy, and recording clinical data accurately within EMR (Electronic Medical Record) systems.
- Manage data collection, entry, and management
- Ensure compliance with HIPAA regulations by safeguarding patient confidentiality during all phases of research activities.
- Conduct clinical laboratory tests and review results to support clinical development efforts while maintaining thorough documentation for audits.
- Stay updated on FDA regulations, GCP standards, and clinical trial best practices to ensure ongoing compliance and quality assurance.
Qualifications
- Understanding of clinical trials management, including regulatory submissions, documentation review, and compliance management.
- Familiarity with medical terminology, blood sampling techniques, phlebotomy procedures, and vital signs monitoring. Certification in ICH GCP (Good Clinical Practice) from a recognized issuer;
- Excellent analysis skills with attention to detail for accurate data collection and reporting.
- Ability to interpret complex regulations such as FDA guidelines and HIPAA requirements effectively.
- Requires a Bachelor’s degree from an accredited college or university with a major in a social or biological science
Pay: $51,585.00 - $67,062.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
Work Location: In person