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Clinical Research Coordinator I

University of Florida

Gainesville, FL

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JOB DETAILS
SALARY
$46,000–$48,000 Per Year
SKILLS
Anesthesiology, Billing, Board Meeting, Clinical Research, Clinical Trial, Communication Skills, Data Analysis, Data Collection, Detail Oriented, Document Management, Epic Systems, Establish Priorities, GCP (Good Clinical Practices), Healthcare Providers, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Maintain Compliance, Medical Record System, Medical Treatment, Multitasking, Nursing, Operations Processes, Organizational Skills, Patient Care, Pharmacovigilance, Presentation/Verbal Skills, Progress Reports, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Submissions, Reporting Skills, Research Protocols, Staff Training, Time Management, Writing Skills
LOCATION
Gainesville, FL
POSTED
4 days ago
The Clinical Research Coordinator I supports and coordinates clinical research activities within the Department of Anesthesiology. Working closely with the Manager of Clinical Research, this position oversees study operations, including participant recruitment and enrollment, informed consent, scheduling and coordinating study visits, protocol compliance, regulatory submissions, and billing compliance. The coordinator also assists with quality assurance projects, supports the successful execution of clinical trials, maintains required certifications and competencies, and participates in ongoing professional development to ensure adherence to University and Institutional Review Board requirements.
Classification Title:

Clinical Research Coordinator I

Classification Minimum 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.

Job Description:

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.

Other duties as assigned

Expected Salary:

$46,000 - $48,000 annually. Commensurate with experience

Required Qualifications:

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.

Preferred:
  • Bachelor's degree in a related field preferred.
  • Prior clinical research experience preferred.
  • Working knowledge of the Epic electronic health record (EHR) system preferred.
  • Familiarity with monitoring and tracking study-funded services.
  • Demonstrated ability to collect, compile, analyze, and evaluate data from clinical research studies.
  • Ability to interact effectively with patients in a perioperative care environment.
  • Strong organizational skills with the ability to plan, coordinate, and prioritize multiple work assignments.
  • Ability to work independently while maintaining a high level of accuracy and attention to detail.
  • Excellent verbal and written communication skills.
  • Proven ability to establish and maintain effective working relationships with patients, research participants, healthcare providers, and colleagues.
  • Strong multitasking and time-management skills, with the ability to effectively prioritize competing responsibilities in a fast-paced environment.
Special Instructions to Applicants:

To be considered for this opportunity, upload a cover letter and your resume.

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

Health Assessment Required:Yes

 

About the Company

U

University of Florida