Clinical Research Coordinator

Clinical Research Coordinator 2 (A) – University of Miami

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The Surgery department has an exciting opportunity for a Clinical Research Coordinator 2 (A) position. The incumbent 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, and 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.

• Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
• Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
• Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
• Maintains study binders and filings according to protocol requirements, UM and department policy.
• Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
• Monitors, documents, reports, and follows up on study unanticipated/adverse events and protocol deviations.
• Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
• Assists with study orientation and protocol related in‑services to research team andimea clinical staff.
• Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
• Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
• Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
• Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Adheres to University and unit‑level policies and procedures and safeguards University assets.

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.

• Bachelor’s degree in relevant field
• Minimum 2 years of relevant experience

• Reviews and administers informed consent forms to study participants.
• Schedules patients for research‑related visits and contacts patients for clinical follow‑up requirements.
• Coordinates activities between departments to accomplish study goals.
• Assists investigators in study related tasks, follow‑up visits, procedures, and assessments as required per protocol.
• Maintains updated records of long‑term follow‑up participants, collects and required data on a timely basis, responds to sponsor queries.
• Retains records of payments to study participants.
• Completes patients’ data forms and reviews medical charts for patients’ vital signs and other medical data to complete case report forms.
• Maintains records of study results and study participants.
• Keeps an active pool of study candidates to ensure availability.
• Adheres to University and unit‑level policies and procedures and safeguards University…