Clinical Research Coord I
About The Position
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. Maintains study source documents; 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. Instructs 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. 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. 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.
Requirements
- Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- Bachelors Degree
- Clinical research 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
Responsibilities
- 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
- Maintains study source documents
- 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
- Complies with federal, state, and sponsor policies and manage essential regulatory documents
- Instructs 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
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
