The Department of Medicine, Division of Cardiology seeks an experienced Manager – Clinical Research Operations for an innovative program in cardiovascular disease research and clinical trials. The manager supervises the organization and administration of hybrid effectiveness-implementation trials focused on cardiovascular disease prevention and lifestyle and behavioral interventions. The manager supervises staff, trial conduct and implementation, collaboration with internal and external investigators and data coordinating centers, and community engagement. The manager ensures that programs are implemented efficiently, on schedule, and with strong protocol fidelity. This individual has strong communication and supervisory skills, attention to detail to maintain programmatic and trial integrity, and commitment to community engaged research.
1. Supervise administration of clinical trials including direct supervision of recruiters and assessors; liaise with co-investigators and data centers; oversee implementation of trial operations according to protocol and Good Clinical Practice; and ensure efficient communication to prevent deviation or workflow breakdowns. 2. Hire, train, and supervise study staff; oversee and delegate recruitment and assessment responsibilities to study staff; conduct routine checks to verify integrity of data capture; provide regular feedback to study staff to maintain high-quality practice; and model constructive problem solving with study stuff to foster a culture of integrity. 3. Maintain rigorous attention to clinical trial implementation, including supervising meeting recruitment benchmarks; verification of adherence to protocol schedule and documentation; attention to retention and efficiency. 4. Lead communication with multiple internal and external partners and research program collaborators. This includes interfacing with data coordinating centers and utilizing reports and study results to address recruitment, retention, and other problem-solving; coordination with study sites to ensure efficiency of recruitment and collaborative partnership; coordination of community members serving as partners in study implementation; and scheduling and leading routine meetings including preparation of meeting agendas and circulation of meeting results and minutes. 5. Demonstrate commitment to communicate engage including the organization and scheduling of meetings with community partners; coordination of presentation and updates to partner sites collaborating with the program; and support of logistical needs related to community engagement. 6. Conduct financial oversight and monitoring of study budget and allocations; maintain records to verify expenditures and cost monitoring; participate in routine financial reviews with University post-award staff; and support accurate and timely payments to collaborators and participants. 7. Participate in submission of regulatory requirements and documentation as pertinent to the IRB, data and safety monitoring board, and the NIH.
Supports Clinical Research operations and performs various budgetary functions comprised of multiple grant-based awards, institutional funding, and tuition revenue; develops program-specific budgets as well as the annual operating budget. Manages all resources and multiple training grants and assists scholars and trainees in utilization of funds. Manages space utilization. Contributes to the development and implementation of web-based systems to support operations and training programs.
Rigorous attention to detail, ability to ensure that programs are implemented efficiently, on schedule, and with strong protocol fidelity. This individual must have strong communication and supervisory skills, attention to detail to maintain programmatic and trial integrity, and commitment to community engaged research.
Position is in-office/onsite 80%, may work remotely 20%. There will be variable travel to clinics in the Pittsburgh, PA, region where research is being conducted to oversee activities. Such visits are anticipated as 2-4 times monthly for administrative and organizational purposes. The job will provide reimbursement for transportation.
Must be able to be onsite 80% of the time and must be able to travel to sites as needed in Pittsburgh area. Must be able to move between offices, sites and university as needed.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
Job Details
- Assignment Category: Full-time regular
- Job Classification: Staff.Manager - Clinical Research Operations
- Job Family: Research
- Job Sub-Family: Clinical Research
- Campus: Pittsburgh
- Minimum Education Level Required: Bachelor's Degree
- Minimum Years of Experience Required: 3
- 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: mon-friday standard
- 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: 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, Cover Letter
- Optional Documents: Not Applicable