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 but are not limited to:
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
Education and Experience
Four years of Clinical Research Coordinator experience
License/Certification
GCP
Research Professional Certificate – CCRC or exam eligibility preferred
