The Department of Plastic Surgery is currently recruiting a Clinical Research Coordinator III (CRC), to recruit and follow subjects on multiple inpatient, outpatient clinical trials, to this nationally recognized clinical and research institution. The CRC will complete various tasks as defined within a Senior level Clinical Coordinator role, examples of some include assisting with consent, review eligibility criteria for prescreening, assist the investigators with regulatory submissions to PittPro and Central IRBs, create recruitment materials for Pitt+me and other recruitment focused websites and manage clinical trials.gov submissions. CRC tasks as described within each core content areas described above.

Equivalent relevant work experience may be substituted for degree requirement. This position will rotate between UPMC hospitals: Magee Women's Hospital, Mercy Hospital, Presbyterian and Shadyside hospitals, and the Urology and Plastic Surgery outpatient clinics located in Oakland and Shadyside, depending on the needs of the specific clinical trial assignments. Clinical coordinator research certification preferred, either ACRP or SOCRA. EEO/AA/M/F/Vets/Disabled.

Prepares grant applications, manuscripts, Institutional Review Board (IRB) applications, research papers, and assists with complex research papers. Audits research studies, monitors study budgets, resolves complex data collection issues, and implements protocol-specific study recruitment plans. Trains staff and oversees student workers; leads team meetings. Monitors study budgets and orders supplies.

Essential functions include:

• Screening, recruitment, tracks follow up tasks per protocol windows and completes research assessments on study participants on multiple trials.

• Completes and adheres to study protocols, and Institutional Review Board (IRB) renewal, modification, and approved protocols.

• Follows ICH GCP E6 R3 guidance and State and Federal regulations as applicable to study project regulatory requirements. Assists with training staff on proper and best study research techniques, as directed.

• Mentors and educates staff and student workers as directed.

• Ensures proper protocols are followed and quality assurance of research and related work.

• Corrects data collection issues.

• Verifies that all data is entered in a timely and complete manner.

• Will perform regular quality assurance/quality control checks.

• The individual will assist the clinicians, investigating physician(s)/Principal Investigator(s) (PI) and the clinical research team through demonstration of a proficient knowledge level in the following 6 research trial core content areas:

1. Scientific Concepts and Research Design, 2. Ethical and Participant Safety Considerations, 3. Product Development and Regulation, 4. Clinical Trial Operations (GCP), 5. Study and Site Management, and 6. Data Management and Informatics

• This individual must have the ability to focus, be organized with attention to detail, and possess ability to multitask between multiple clinical trials assigned.

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The University of Pittsburgh is an equal opportunity employer / disability / veteran.