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||Miami, FL United States
|| Healthcare, Other
Clinical Research Coordinator 3|
The Department of Obstetrics and Gynecology has an exciting opportunity for a Full-Time Clinical Research Coordinator 3 to work on the UHealth Campus. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studiesí daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each studyís integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administr ative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.
Coordinates the implementation of multiple complex clinical research protocols.
Develops SOPs and templates with guidance from the PI/Clinical Research Manager.
Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.
Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.
Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.
Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.
Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.
Assist PIs and study team with regulatory IRB submissions, continuing reports, and modifications of protocols, including maintaining delegation of authority logs, deviation logs, adverse event logs for all studies.
Assists PIs and study team with screening, recruitment, including informed consent of participants per protocol guidelines.
Assists PIs and study team with scheduling and contacting study participants for appointments as needed.
Assists PIs and study team with data collection, data entry and completing standard operating procedures for quality assurance reviews of data as needed.
Assists PIs and study team with monitoring and tracking of study visits per protocol guidelines.
Maintains required CITI Research Certifications and RSQA education for research support staff as mandated by the University and Supervisor.
Assists PIs and study team with essential documentation including maintenance of study binders, shadow records, and record reviews for study specific data collection per protocols.
Assists in the pre-award process for feasibility assessment, budget, and study start up as needed.
Develops, verifies, and implements procedures to accomplish research goals.
Implements research protocol and monitors participant adherence to protocol.
Maintains database of department, providing research training and support, ensuring CITI certification and relevant trainings are up to date.
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 required
Minimum 4 years of relevant experience required, FDA experience highly desired/preferred
Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months
Skill in collecting, organizing and analyzing data.
Ability to recognize, analyze, and solve a variety of problems.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work independently and/or in a collaborative environment.
Any appropriate combination of relevant education, experience and/or certifications may be considered.
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