What are the responsibilities and job description for the Clinical Research Coordinator (31656) position at GI Alliance?
Work to build the research department in scope, size, reputation, and professionalism.
- Assist with recruitment of studies, budget evaluation and negotiation, protocol
- Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal
- Obtain and maintain consent of patients with the highest ethical standards.
- Work with other research department staff in a leadership role including management,
- Work directly with patients to screen, consent, take history, complete necessary exams
- Communicate with and support patients and their families as necessary.
- Work with the EMR and data management systems to complete EDC, eCRFs, find
- Must have or gain knowledge of relevant software/programs.
- Have a basic and working knowledge of trial design, statistical methods, etc.
- Triage, record, and report adverse events. Record and report any protocol deviations.
- Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings
- Create and maintain department SOPs, NDAs, CVs, certifications, etc.
- Evaluate, purchase, maintain necessary equipment.
- Maintain HIPAA compliant communication and confidentiality, at all times.
- Maintain study budgets and monitor invoicing, billing, and payments.
- Participate in site visits, SIVs, monitoring, etc.
- Complete necessary study close-out steps and documentation.
- Assist with other duties assigned.