Clinical Research Coord II

Selects and recruits study participants to enroll in various studies and protocols; participates in the informed consent process of study subjects; supports the safety of clinical research patients/research participants; coordinates protocol-related research procedures, study visits, and follow-up care; screens, completes case report forms (paper & electronic data capture), and addresses queries.  Documents investigational product (drug/device) accountability.

Maintains and creates study source documents and electronic databases; reports adverse events; understands Good Clinical Practice (GCP) and regulatory compliance; educates subjects and family on protocols, study interventions, study drugs, etc.; complies with institutional policies, standard operating procedures (SOPs), and guidelines. Must comply with federal, state, and sponsor policies and manage essential regulatory documents.  Acts as a liaison for research subject, investigator, IRB, sponsor, and heatlhcare professionals.

Instructs healthcare team personnel (nurses, technicians, and students) regarding equipment operation, monitoring procedures, and patient care details associated with clinical studies. Develops in-service education programs as needed for clinical research. Develops advertisement materials.  Aids in managing research volunteers involved their research projects.

Summarizes conditions of patients and fills out data collection forms, which involves explaining procedures, protocols, and patient condition to patients and families.

Researches regulatory compliance participation in activities to initiate and maintain a current regulatory file; prepares and submits documents related to research protocols to both internal (UF-IRB, UF-CTC office, UF-OCR, etc.) and external (FDA, WIRB, etc.) organizations as required; completes end-of-study procedures; schedules and participates in sponsored research monitoring visits and QA audits; ensures the integrity and quality of the research protocol is maintained and the trial is conducted in accordance with GCP guidelines; attends UF-IRB 01 full board meetings as necessary.  Manages study finances including sponsor invoicing and resolving study subject billing issues, participates in the development, and conduct of study billing plans.  Aids in clinicaltrials.gov submissions.

Prepares progress reports; periodically reviews study protocols and suggests changes as needed. Reviews research projects periodically to ensure all procedures and aspects comply with nursing standards and policies. Promotes Human Subjects Protections within clinical research areas.

Other duties as assigned

• Bachelors Degree
• Clinical research experience and Clinical research coordinator experience
• Working understanding of the Epic electronic health record software
• Working understanding of monitoring study-funded services
• Ability to collect, collate, analyze, and evaluate data from clinical research studies
• Ability to work with patients in the perioperative care environment
• Ability to plan, organize, and coordinate work assignments
• Ability to work effectively and independently
• Ability to communicate effectively verbally and in writing
• Ability to establish and maintain effective working relationships with others
• Able to multitask when needed; must have excellent time-management skills and be able to effectively prioritize