Company Overview
Professional Health Care of Pinellas is an independently owned practice dedicated to delivering high-quality patient care since 1997. Our team comprises over 85 healthcare providers working across inpatient, outpatient, and long-term care settings throughout the region. We are committed to expanding our services and serving our community with excellence.
Job Summary
We are seeking a detail-oriented and proactive Clinical Research Coordinator to oversee and facilitate clinical trials within our organization. The ideal candidate will possess strong organizational skills, clinical trials (phase II-IV) management experience, and a thorough understanding of medical terminology and regulatory requirements. As a vital member of our research team, you will coordinate study activities, ensure compliance with protocols, and support data collection efforts to advance clinical development initiatives.
Duties
- Coordinate all aspects of clinical trials, including participant recruitment, scheduling, and follow-up to ensure smooth study operations.
- Review and verify study documentation for accuracy, completeness, and regulatory compliance.
- Monitor patient progress throughout trials by collecting vital signs, blood samples, and other clinical data while ensuring patient safety and adherence to protocols.
- Manage data entry, data management systems, and ensure accurate documentation in electronic medical record (EMR) systems.
- Ensure compliance with FDA regulations, ICH GCP standards, HIPAA privacy rules, and CDISC data standards throughout the research process.
- Supervise research staff and collaborate with multidisciplinary teams to maintain high standards of quality and efficiency.
- Assist in preparing reports for regulatory submissions and audit readiness by maintaining meticulous records of trial activities.
Requirements
- Experience working on a clinical research team and coordinating multiple clinical trials simultaneously.
- Strong knowledge of clinical trials management, including FDA regulations, ICH GCP guidelines, and HIPAA compliance.
- Familiarity with medical terminology, blood sampling techniques such as phlebotomy, and clinical laboratory procedures.
- Experience with data collection tools, statistical software, EMR systems, and adherence to CDISC standards for data management.
- Certification in Good Clinical Practice (GCP) from a recognized issuer or equivalent training such as an ICH GCP certificate. Prefer active IATA training and CCRP or CCRC.
- LPN or Certified Medical Assistant is preferred with relevant experience in clinical development is highly desirable.
- Experience with EDC Data Entry, IP dispensation - blinded and unblinded and IRB systems- ISF filling.
- Excellent analysis skills with the ability to review documentation thoroughly while maintaining attention to detail.
- Local travel is sometimes required
Join us as we advance innovative healthcare solutions through rigorous clinical research! PHC of Pinellas is an equal opportunity employer and a drug free and smoke free work environment.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Paid time off
Experience:
- Clinical Research Coordinator: 1 year (Required)
- Phlebotomy: 1 year (Required)
License/Certification:
- LPN or Certified Medical Assistant (Preferred)
- CCRP or CCRC (Preferred)
Work Location: In person
