Clinical Research Program Manager
Med-Medicine - Pennsylvania-Pittsburgh - (26007149)
Working knowledge of GCP, human subjects protection, IRB processes, and federal research regulations.
Strong leadership, organizational, and problem-solving skills, with the ability to manage multiple concurrent projects and deadlines.
Excellent written and verbal communication skills.
Experience with budgets, research billing, and financial monitoring.
Proficiency with Microsoft Office and research data systems (e.g., REDCap, electronic regulatory binders, clinical trial management systems).
Attention to detail and commitment to confidentiality and ethical research conduct.
Job Summary
Manages and facilitates overall day-to-day research administration activities and operational functions. Collaborates to ensure compliance, productivity, and progress. Develops and implements program policies and procedures and adheres to protocols, regulations, and budgets. Coordinates program events and logistics. Performs budgetary functions.
Essential Functions
Oversee the day-to-day operations of clinical research studies, including start-up, recruitment, enrollment, retention, data collection, and close-out, ensuring protocols are implemented on schedule and with strong fidelity. Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports; maintain essential and source documentation; and ensure compliance with Good Clinical Practice (GCP), FDA regulations (21 CFR), HIPAA, and NIH requirements. Develop and implement standard operating procedures and quality control checks to verify the accuracy and integrity of data capture; prepare for and respond to audits and monitoring visits. Monitor study budgets and expenditures, work with pre-award and post-award staff on budget development and routine financial reviews, support contract execution, and ensure timely and accurate payments to collaborators and participants. Serve as the primary operational liaison with principal investigators, sponsors, data coordinating centers, study sites, clinical departments, and community partners; schedule and lead routine team meetings and circulate agendas and minutes. Track program metrics and milestones, prepare progress reports and presentations, and assist with grant applications, manuscripts, and other research documents. Perform other duties as assigned.
Physical Effort This position is primarily sedentary and involves prolonged periods of sitting, computer use, and reviewing documents. Frequent walking between office, clinical, and research areas may be required. Occasional bending, reaching, and lifting or carrying study materials, files, and supplies up to 25 pounds is required. Periodic travel to affiliated research sites within the Pittsburgh region may be necessary.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
Assignment Category: Full-time regular
Bargaining Unit Eligibility: This position is bargaining unit eligible
Job Classification: Staff.Research Program Manager
Job Family: Research
Job Sub Family: Research Program Support
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.
Additional details about Required Licensure/Certification: Bachelor’s degree in a health, science, or related field, and a minimum of five years of clinical research experience, including at least two years in a supervisory or lead role Demonstrated experience managing clinical research studies in an academic, hospital, or healthcare setting. Preferred: Master’s degree in public health, nursing, health administration, or a related field. Professional certification such as CCRP, CCRC, or PMP.
Work Schedule: Monday-Friday 8am-4:30pm
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: Not Applicable
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