Clinical Research Coordinator 2 Full Time Bascom Palmer Eye Institute Miami, FL

Clinical Research Coordinator 2

The University of Miami has an exciting opportunity for a Clinical Research Coordinator 2 with Bascom Palmer Eye Institute, McKnight Vision Research Center in Miami, Florida.

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.

• 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 and 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.

Education:

Bachelor's degree in relevant field or equivalent

Experience:

Minimum 2 years of relevant experience

Knowledge, Skills and Attitudes:

• 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 University's core values.
• Ability to work independently and/or in a collaborative environment.

Department Specific Functions

• Flexibility to travel to all BPEI sites as needed
• Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records.
• Ability to handle multiple clinical trials with several principal investigators.
• Serve as back up coordinator to other clinical trials.
• Completes corrections/queries required at audits/monitor visits and takes action to correct deviations as needed.
• Establishes/maintains contact with patient/participants, health care providers, community agencies and study sponsors.
• Updates appropriate agencies (such as sponsors, IRB, etc) regarding current status of research project.
• Provides in-service education to staff and patients/participants about research protocols
• Prepares and submits annual reviews to the Institutional Review Board (IRB).
• Maintains consent forms and sponsor correspondences.
• Notifies IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations.
• Implements research protocol and monitors participant adherence to protocol.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

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