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Clinical Research Coordinator III
2 months ago
University of Miami is seeking a highly skilled Clinical Research Coordinator III to join our team in Sunrise, Florida.
About the RoleThe successful candidate will assist the Principal Investigator in the conduct of all aspects of clinical trials, under the direct supervision of the Principal Investigator and Clinical Research Manager. The Clinical Research Coordinator III will provide support to the research team in the management of multiple research protocols to ensure compliance with FDA, WHO, UM, and CRS regulations and policies.
Key Responsibilities- Assist in the organization and preparation of Site Initiation Visits (SIV) and provide research support to patients and their families.
- Attend site disease group tumor board meetings and site disease group collaborative meetings.
- Work with coordinators to ensure that all eligibility source documents are complete and eligibility checklists are complete.
- Execute the plan developed for collection of protocol-specific subject specimens, such as pharmacokinetics samples, blood specimens, and tissue samples, as per protocol.
- Provide oversight in completing the protocol preparedness and start-up process for all trials within assigned site disease group.
- Take the lead in research study kit management and work closely with the research lab to ensure proper management of specimen orders.
- Assist in maintaining logs to track both currently enrolled and follow-up participants.
- Mentor data coordinators in entering data onto case report forms and/or into computer databases.
- Ensure data integrity and consistency in computer databases and written records by reviewing entered data for accuracy.
- Monitor adherence to protocol and take action to report and correct deviations or other problems.
- Record and report adverse events, serious adverse events, and unexpected problems in compliance with federal regulations, the protocol, and UM policies to the sponsor and/or IRB as directed by the PI.
- Ensure that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.
- Demonstrate a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center and provide coverage for other CRS SDGs as needed.
- Assist the Principal Investigator with physical exams, vital signs, and placing orders for exams.
- BS degree in science, healthcare, or a related field.
- A minimum of 4 years of effective work-related experience in clinical settings, hospitals, or research.
- High-level interpersonal skills.
- Excellent English oral and written communication skills and strong computer skills.
- A Research Coordinator Certification by the ACRP is required.
- Knowledge of medical terminology.
- Ability to manage multiple tasks simultaneously.
- Attention to detail and accuracy.
The University of Miami is a top-tier institution of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. We are committed to attracting a talented workforce to support our common mission of transforming lives through teaching, research, and service.
Benefits- Holiday pay.
- 403b retirement plan.
- Sick pay.
- Wellness and fitness programs.
- Employee assistance programs.
- Medical benefits.
- Dental benefits.
- Vision benefits.
- Benefits start day 1.
- Continuing education.