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|Clinical Research Coordinator 2|
Company: University of Miami
Location: Miami, FL
Employment Type: Full Time
Date Posted: 08/17/2022
Expire Date: 10/17/2022
Job Categories: Healthcare, Other
Clinical Research Coordinator 2|
The Sylvester Comprehensive Cancer Center has an exciting opportunity for a Full-Time Clinical Research Coordinator 2 to work on the UHealth Campus. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.
Assist Principal Investigator and Sr. Manager with assessing feasibility.
Organizes and participates in Study Initiation Visits (SIV) in collaboration with the Study Team.
Attends site disease group tumor board meetings and site disease group collaborative meetings.
Works directly and communicates with SDG Leader and Sr. Managers to meet SDG goals; maintains SDG protocol portfolio with assistance from CRS leadership and tracks accruals for SDG.
Participates in the orientation, mentoring, and coaching including Jr. Clinical Research Coordinator and Data Coordinator. Identifies educational opportunities for members of disease cluster and ensures coverage for attendance when necessary.
Provide patient and staff education (in-services) regarding all Site Disease Group (SDG) specific protocols. Assist the PI in providing the patient and his/her family with a thorough description of the treatment and possible side effects related to study treatments.
Review patient data with the PI to determine patient eligibility for protocol enrollment. Ensure all eligibility forms are completed and submitted for appropriate review.
Assists PI in obtaining informed consent and document the informed consent process. Enter required information in Velos.
Ensure study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents. Obtain relevant medical information from patient clinic charts/medical records. Maintain logs/progress reports to track both currently enrolled as well as follow-up participants. Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.
Determine data to be collected and develop forms for collecting/summarizing data. Work with the Data Coordinator to enter data onto case report forms and/or into computer database as appropriate. Complete corrections/queries required at audits/monitor visits. Ensure data integrity and consistency in computer database and written records.
Execute the plan developed for procurement of protocol specific subject specimens, i.e. pharmacokinetics, tissue procurement as necessary and ensures it is successfully completed.
Take action to report and correct deviations or other problems. Verify accuracy of research data and monitor data quality control. Record serious adverse events, etc. in compliance with applicable regulations and report to IRB/Sponsor. Actively participates in monitoring visits/site audits, etc.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
Bachelorís degree in relevant field
Minimum 2 years of relevant experience
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Commitment to the Universityís core values.
Ability to work independently and/or in a collaborative environment.