Clinical Research Coord II
About The Position
This position involves recruiting and enrolling participants into clinical studies, ensuring patient safety, and coordinating research procedures. The role requires meticulous documentation, adherence to Good Clinical Practice (GCP) and regulatory compliance, and educating subjects and families about study protocols. The Clinical Research Coordinator II will also act as a liaison between various stakeholders, including the research subject, investigator, IRB, sponsor, and healthcare professionals. Additionally, this role involves educating healthcare team personnel, developing educational programs, creating advertisement materials, and managing research volunteers. The position also entails summarizing patient conditions, filling out data collection forms, preparing and submitting regulatory documents, managing study finances, and ensuring the integrity and quality of research protocols. The role may also involve assisting with clinicaltrials.gov submissions, preparing progress reports, and promoting Human Subjects Protections.
Requirements
- Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
- 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
Nice To Haves
- 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
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.
- 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.
- Manages essential regulatory documents.
- Acts as a liaison for research subject, investigator, IRB, sponsor, and healthcare professionals.
- Instructs healthcare team personnel 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 in their research projects.
- Summarizes conditions of patients and fills out data collection forms.
- Explains 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 internal and external organizations.
- 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.
- Performs other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
