Manager - Clinical Research Coordinator

Manages patient/subject recruitment for multiple, simultaneous studies and identifies and enrolls patients into clinical trials utilizing appropriate enrollment standards. Oversees day-to-day implementation of study protocols/clinical trials as well as medical histories and lab values. Prepares accurate documentation for human research studies and assists in the preparation of abstracts and manuscripts for publication. Completes all regulatory documents and ensures all protocol and regulatory standards adherence.

Job Summary Manages day-to-day responsibilities for staff in research study administration, recruitment, and logistics. Develops and implements operational plans and systems for recruitment, data collection, and meeting project goals and deliverables. Ensures study protocols are met and adhered to and facilitates an organizational system for accumulated study data forms and procedures.

Essential Functions Conduct oversight of complex clinical procedures, training on protocols, data management, data analysis, study design, completing regulatory documents, implementation of study protocols, research planning, subject recruitment, screening subjects, and subject flow while maintaining research documents/case report forms and source documents. Assist in preparing for audits and study monitor visits, attending Data and Safety Monitoring Board (DSMB) meetings, and representing a PI at investigator meetings. The incumbent reports progress and special issues at staff meetings and works with the initial and ongoing Investigational Review Board (IRB) and Clinical Translational Research Center (CTRC) submissions, modifications, and adverse event reporting.

May supervise the work of study specific staff and research students involved in subject recruitment, specimen packaging, and clerical tasks. The incumbent reviews invoices and billing from research entities and other departments. Some involvement in clinic work will be required including the performance of phlebotomy with minor laboratory skills, electrocardiograms, pulmonary function testing, and other respiratory testing.

Physical Effort The incumbent must stand at least 2-4 hours/day, walk 1 mile/day, maneuver around heavy and fragile equipment and carry case report forms and research records (>25 lbs.)

The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.

The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.

Assignment Category: Full-time regular

Job Classification: Staff.Manager - Clinical Research Coordinator

Job Family: Research

Job Sub Family: Clinical Research

Campus: Pittsburgh

Minimum Education Level Required: Bachelor's Degree

Minimum Years of Experience Required: 3

Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Work Schedule: Monday -- Friday, 8am-4:30pm

Work Arrangement: Monday -- Friday, 8am-4:30pm

Hiring Range: TBD Based Upon Qualifications

Relocation_Offered: No

Visa Sponsorship Provided: Yes

Background Check: For position finalists, employment with the University will require successful completion of a background check

Child Protection Clearances: Not Applicable

Required Documents: Resume

Optional Documents: Cover Letter

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