Clinical Research Project Manager A
About The Position
The Clinical Research Project Manager A provides project management, regulatory support, staff oversight, expertise, and administrative support for clinical trials conducted through the Penn Infectious Diseases Clinical Research Unit and the Department of Medicine Infectious Disease Clinical Trials Unit. Projects include HIV, COVID-19, and other infectious diseases; observational research and Phase I–IV clinical trials; and investigator- or industry-initiated studies of varying complexity. The role may involve consulting or serving as the primary project manager accountable for study execution, operational planning, and results. Work is conducted with supervision and in accordance with Good Clinical Practice, approved study protocols, and applicable regulatory requirements. The position has close supervision from the Director on projects and manages 1–2 staff, while retaining research coordinator duties as needed. The position is contingent upon funding. The Project Manager supports investigators and coordinators, oversees study teams and study delivery, and leads study intake, feasibility, and start-up. The role includes regulatory submissions and compliance, development of study plans and documents, recruitment and timeline management, budget oversight, and data and sample management. It also includes overseeing patient care as specified by study protocols, preparing teams for audits, and contributing to best practices and standard operating procedures. The role requires up to full-time onsite work to manage staff and projects, with the possibility of one remote workday per week. The position is based in Philadelphia, Pennsylvania.
Requirements
- Bachelor's degree and 3–5 years of related experience, or an equivalent combination of education and experience.
Responsibilities
- Manage research studies conducted through the ACTU Clinical Trials Unit in accordance with Good Clinical Practice and applicable regulatory guidelines.
- Conduct study-related visits and procedures, including recruitment, as needed to meet project needs.
- Lead study intake and drive study start-up, including feasibility assessments; liaise with sponsors, vendors, CROs, and principal investigator teams; and complete start-up regulatory documents and submissions.
- Supervise, manage, and train study teams; develop and drive study timelines and strategies; and directly manage 1–2 staff.
- Develop, create, and review regulatory submissions, including protocols, consents, annual reports, and unanticipated problem reports; respond to regulatory reviewer inquiries; and assist with IND/IDE/CTA exemption determinations.
- Develop study-specific source documents, training slides, manuals of procedures, CRFs, and SOPs.
- Lead internal and external meetings and ensure unresolved issues are followed through to resolution.
- Manage study budgets and ensure payments are received and paid out in a timely manner.
- Oversee data and sample management, including compliance checks, and help teams prepare for audits.
- Provide project management and regulatory support to investigators and coordinators across clinical trials and observational research.
- Oversee study teams, lead team meetings, drive timelines and recruitment, and monitor overall performance.
- Generate study-specific plans and documents, contribute to study budgets, and ensure consistent use of study tools, training materials, processes, policies, and procedures.
- Lead problem-solving and resolution efforts; review study status and monitoring reports to identify and address potential issues.
- Provide leadership and guidance to research personnel in day-to-day operational activities.
- Oversee regulatory duties, submissions, and compliance checks, and participate in documenting best practices and SOPs.
- Oversee delivery of patient care as defined in study protocols and ensure trials meet expectations and comply with approved protocols and regulatory requirements.
- Perform research coordinator duties as needed and other duties as needed.
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
- Flexible spending accounts for eligible health care and dependent care expenses.
- Tuition assistance for employees, spouses, and dependent children at Penn, and for dependent children at other institutions.
- Basic, matching, and supplemental retirement plans with pre-tax or Roth savings options and investment choices through TIAA and Vanguard.
- Substantial time away from work during the year.
- Long-term care insurance options.
- Wellness and work-life programs and resources.
- Professional and personal development resources.
- Access to University libraries, athletic facilities, cultural activities, and recreational resources.
- Discounts and special services, including discounts on arts, entertainment, transportation, and other goods and services.
- Flexible work options and hours.
- Forgivable home-ownership loan for eligible employees buying a home or residing in West Philadelphia.
- Adoption expense reimbursement for eligible employees, for up to two adoptions in the household.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
