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The University of Miami, Bascom Palmer Eye Institute, Department of Research, has an exciting opportunity for a Clinical Research Coordinator 3.

The Clinical Research Coordinator 3 (A) 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 studies’ daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study’s 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 administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.

CORE JOB FUNCTIONS        

 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.

Organizes/manages site visits and internal/external auditing activities as assigned.

Coordinates research team meetings; assures communications across-the-board.

Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.

Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.

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:
Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months

Experience:  
Minimum 4 years of relevant experience 

Knowledge, Skills and Attitudes:
•    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.

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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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