Clinical Research Coord II

The Lung Transplant Research Division at UPMC is a dynamic and highly specialized research department dedicated to advancing clinical knowledge and improving outcomes for lung transplant patients. The division supports a diverse and growing research portfolio, currently managing clinical research studies in various phases of enrollment, start-up, and follow-up, with additional studies anticipated in the near future.

The research team consists of one dedicated Research Coordinator and two Primary Investigators who work collaboratively with a multidisciplinary group of ancillary support staff, including Physician Assistants (PAs), Certified Registered Nurse Practitioners (CRNPs), operating room personnel, physicians, and other clinical and administrative staff. Together, these individuals contribute to the successful execution of research activities, regulatory compliance, patient recruitment, data collection, and study oversight.

Research activities are conducted across multiple UPMC facilities, including the UPMC Shadyside Medical Building, Falk Medical Building, and the UPMC Presbyterian operating rooms, requiring close coordination among clinical and research personnel.

This position plays a critical role in supporting the division's research mission by ensuring high-quality study conduct, fostering collaboration among multidisciplinary teams, and contributing to the ongoing expansion of innovative research opportunities within the Lung Transplant Program.

Qualifications Required:

• Bachelor's degree in a health science, biological science, nursing, public health, or related field.
• Experience coordinating clinical research studies or equivalent research experience; knowledge of clinical research methodology and regulatory requirements; strong organizational, communication, and interpersonal skills; proficiency with Microsoft Word and Excel.

Qualifications Preferred:

Clinical research coordination experience in transplant, thoracic surgery, pulmonary medicine, or related specialties. Experience with patient screening, recruitment, and informed consent processes: experience with protocol management and regulatory submissions to the IRB and other oversight committees; experience with research databases and electronic data capture systems; familiarity with GCP, human subject protections, and research compliance requirements.

Conducts research assessments on study participants. Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Assists with training staff. Ensures adherence to protocols and corrects issues with data collection.

The position will coordinate and manage day-to-day operations of clinical research studies within the Lung Transplant Program; screen, recruit, consent, and enroll research participants in accordance with approved protocols and regulatory requirements; maintain compliance with Good Clinical Practice (GCP), institutional policies, sponsor guidelines, and applicable federal regulations. GCP compliance is a foundational component of research study conduct. In addition, the position will be responsible for:

• Prepare and submit regulatory documents, including but not limited to Institutional Review Board (IRB) submissions, continuing reviews, amendments, and study closures.
• Coordinate study visits, specimen collection, and research-related procedures.
• Perform accurate and timely data collection, entry, verification, and database management.
• Maintain study files and regulatory binders and ensure completion of required study documentation.
• Assist investigators with protocol implementation and ongoing study management.
• Collaborate with multidisciplinary clinical and research teams across multiple locations.

• Participate in study monitoring visits, audits, and sponsor communications as needed.

• Ability to sit, stand, and walk for extended periods of time.
• Ability to travel between UPMC Presbyterian and UPMC Shadyside campuses.
• Ability to transport study materials and equipment as needed.
• Must have reliable transportation for travel between clinical and research sites.