Clinical Research Coordinator

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The University of Miami, Bascom Palmer Eye Institute, has a full time opportunity for a Clinical Research Coordinator 2 (A) for the Department of Research, in Miami, Florida.

The Clinical Research Coordinator 2 (A) 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.

CORE JOB FUNCTIONS                                                                                                          

• 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.

CORE QUALIFICATIONS                                                                                                         

Education:

Bachelor’s degree in relevant field

Certification and Licensing:

Not Applicable

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 ADDENDUM

Department Specific Functions

• 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. Serves as back up study coordinator to other clinical trials.
• Obtains informed consent from patients/study participants and documents the process in alignment with policies and procedures.
• Recruits patients referred by physicians, schedules study appointments, prepares for and conducts study visits in the clinic.
• Processes and ships participant biological samples to central labs according to safety regulations.
• Collaborates with the research pharmacy to dispense study medication and maintain unmasked study records.
• Completes corrections/queries required at audits/monitor visits and takes action to correct deviations, as needed.
• Establishes/maintains contact with patients/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 study team members about research protocols.
• Enters data into electronic data capture system within specified timelines and meets sponsor’s data lock deadlines.
• Maintains study regulatory files, including delegation of authority logs, training records, and sponsor correspondence.
• Maintains participant files, including informed consent forms, source documents, and participant compensation/reimbursement records.
• Prepares and submits annual continuing reviews to the Institutional Review Board (IRB).
• Notifies IRB of protocol amendments, safety reports, and reportable information in compliance with applicable regulations.
• Implements research protocols and monitors participant and study team adherence.
• Invoices sponsor and performs study account reconciliation with the research administration team.
• Travels to sponsored Investigator Meetings out of state, as needed.
• Flexibility to travel to all Bascom Palmer Eye Institute sites, as needed.

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

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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