What are the responsibilities and job description for the Clinical Research Coordinator position at Professional Healthcare of Pinellas?
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. *This is not a remote position*
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