Clinical Research Coordinator II - FLORIDA DIGESTIVE HEALTH SPEC

Reports to: Lead Clinical Research Coordinator

Job Summary: The Clinical Research Coordinator, (CRC) is to screen, enroll and follow study subjects while ensuring protocol and regulatory compliance and close monitoring while subjects are in study.

Duties Include:

·         Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials

·         Obtain informed consent

·         Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol

·         Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs

·         Review laboratory results, ECGs, and other test results (e.g., MRI and Biopsy reports) for completeness and alert values, ensure investigator review in a timely fashion

·         Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator

·         Schedule patients within visit windows

·         Dispense study medication per protocol and or IVRS system; educate subject on proper administration and importance of compliance

·         Monitor subject progress on study medication

Documentation:

·         Create source documentation

·         Record data legibly, in real time on source documents

·         Accurately record study medication inventory, medication dispensation, and patient compliance

·         Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed

·         Record protocol exemptions and deviations as appropriate with sponsor

·         Maintain copies of patient-specific correspondence in source charts

·         Assist regulatory personnel with completion of continuing/final review reports

Knowledge, Skills, and Abilities:

·         Excellent working knowledge of medical and research terminology

·         Extensive working knowledge of federal regulations, Good Clinical Practices (GCP)

·         Ability to communicate and work effectively with a diverse team of professionals

·         Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word and Excel

·         Excellent interpersonal skills, detailed-oriented and meticulous

·         Ability to work independently in a fast-paced environment with minimal supervision

Experience:

·         Four years of Clinical Research Coordinator experience

 License/Certification:

·         GCP

·         Research Professional Certificate – CCRC or exam eligibility preferred