Clinical Trials Manager - Pulmonary Translational Research Core in Pittsburgh, Pennsylvania at University of Pittsburgh

Clinical Trials Manager - Pulmonary Translational Research Core

Med-Medicine - Pennsylvania-Pittsburgh - (26006348)

The Pulmonary, Allergy, Critical Care, and Sleep Medicine Division is made of up approximately 70 clinical staff and over 100 research staff who work in a variety of locations including: Bridgeside Point, Biomedical Science Tower (BST), UPMC Hospitals including Presbyterian, Shadyside, East, Jameson and Mercy. The division provides world class services across 10 inpatient services at five hospitals and over 70,000 outpatient office visits. We have a major research mission that focuses on basic, clinical, and translational research on the lung, microbiome, COVID-19, sleep medicine, and allergy and immunology.

The Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine invites applications for a regulatory coordinator position for the Pulmonary Translational Research Core. This position supports the Emphysema Research Center (ERC) and other investigators with division providing clinical trial planning, budgeting, and regulatory support. This position will work closely with experienced principal investigators and project coordinators within internationally recognized and impactful lung research programs to coordinate IRB approval, budget development and contracting with local sponsor stakeholders. We seek an experienced clinical regulatory coordinator with a minimum of 3 years of regulatory and budgeting experience with industry and government sponsored clinical trials. Required skills include the drafting, submission, and management of IRB protocols, budgeting for clinical trials, management of industry sponsored clinical trial documentation. Experience with University of Pittsburgh and UPMC clinical trials infrastructure (SCTP, Pitt IRB, Advarra OnCore) is also a plus. Flexible options for work from home.

Regulatory coordinator-leader with experience in clinical trial budgeting and management of clinical trial documentation.

Job Summary

Facilitates and oversees clinical trials and multi-site studies. Directs day-to-day, manages resources, and executes administrative and budgetary matters. Submits clinical trial applications. Assists to develop and implement study protocols, policies, and procedures.

Essential Functions

-Draft and submit protocols to Pitt and external IRB’s

-Budgeting for industry and government sponsored clinical studies

-Management of industry sponsored clinical trial documentation

-Utilization of electronic clinical trial management systems (OnCore and sponsor based)

-Interaction with clinical trial sponsors, auditors, monitors and IRB staff.

-Coordination of monitoring and site initiation visits

-Support of principal investigators and clinical research coordinators

Physical Effort

Must be able to sit/stand for up to 8 hours a day.

Assignment Category: Full-time regular

Job Classification: Staff.Clinical Trials Manager

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: Hybrid: Combination of On-Campus and Remote work as determined by the department.

Hiring Range: To be determined based on 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