Clinical Research Coordinator IIIUniversity of Pittsburgh

Clinical Research Coordinator III

Med-Plastic Surgery - Pennsylvania-Pittsburgh - (26000537)

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 in the Oakland campus and may extend to Shadyside and Cranberry areas, such as: Magee Women's Hospital, Mercy, Presbyterian, Passavant and Shadyside Hospitals and include various Plastic Surgery outpatient clinics located throughout the UPMC hospital systems, depending on the needs of the specific clinical trial assignments. Clinical coordinator research certification preferred, either ACRP or SOCRA will be accepted. EEO/AA/M/F/Vets/Disabled.

Job Summary

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

Essential Functions:

• 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.

• Verify 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, organized with attention to detail, and possess able to multitask between multiple clinical trials assigned.

Physical Effort

Light.

Assignment Category: Full-time regular

Job Classification: Staff.Clinical Research Coordinator III

Job Family: Research

Job Sub Family: Clinical Research

Campus: Pittsburgh

Minimum Education Level Required: Master's Degree

Minimum Years of Experience Required: 1

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.

Additional details about Required Licensure/Certification: Clinical coordinator research certification preferred, either ACRP or SOCRA.

Work Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m.

Work Arrangement: On-Campus: Teams that work on campus, in an office, or in a lab.

Hiring Range: TBD Based Upon Qualifications

Relocation_Offered: No

Visa Sponsorship Provided: No

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




Equal employment opportunity, including veterans and individuals with disabilities.

PI281934544