Clinical Research Coord Ii

7 days ago

Gainesville, United States University of Florida Full time

The full-time Clinical Research Coordinator lI works closely with the Manager of Clinical Research in the
- Department of Anesthesiology and coordinates all aspects of the department’s research component.
- Serves as study coordinator for research protocols and QA projects as assigned. Activities include and are
- not limited to recruiting patients to enroll in studies, obtaining informed consent, coordinating patient visits,
- managing patient visits in accordance with protocol, submitting necessary compliance paperwork, and
- billing compliance.**Duties Include**:

- Selects and recruits study participants to enroll in various studies and protocols; participates in the-
- 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;-
- 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-
- healthcare 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-
- 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**Expected Salary**:
$50,000 - $57,000

**Minimum Requirements**:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

**Preferred Qualifications**:

- 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**Special Instructions to Applicants**:
In order to be considered, you must upload your cover letter and resume.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

This is a time limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

**Health Assessment Required**:

- Yes

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