"Clinical Research Project Manager B"

Job Description Summary

With mentoring from the Clinical Research Program Lead, the Clinical Research Project Manager B will take a leadership role in managing the detailed operations of clinical research studies from startup through closeout, coordinating activities, and assisting with quality control.

Job Description

This individual will be responsible for training clinical research staff, project assignments, staff mentoring, and bi-annual performance appraisal completion. They will ensure that studies are conducted safely and according to the protocol, provide supervision to teams conducting the study, and collaborate with internal and external partners, including other research departments or institutions and study sponsors. They will work with the Clinical Research Program Lead to develop and implement standard operating procedures and unit guidance documents.

This role will also supervise ancillary/support staff on the PDMDC clinical research team. They will oversee regulatory and recruitment processes, working with leadership to support shared responsibilities among the team. They will take a lead role in study recruitment, encouraging provider input, developing a pool of external providers to collaborate on recruitment, and organizing community outreach events. They may also be responsible for coordinating grant applications and contributing to presentations.

This position may also independently manage 1-2 clinical research studies. This includes, but is not limited to, conducting patient visits, collecting and processing specimens, data entry, query resolution, and working with study monitors.

The Clinical Research Project Manager B will report directly to the Clinical Research Program Lead and indirectly to the other investigators within the team. They will also collaborate with departments/stakeholders such as CHPS, Investigational Drug Services/Pharmacy, sponsors, CROs, Subcontractors, and Collaborators to support day to day operations for the study team.

Position contingent upon funding.

Qualifications

• Master's Degree with 3-5 years of related experience or equivalent combination of education and experience is required.
• Excellent verbal/written communication skills required
• Able to work collaboratively on all levels and to gain support of others
• Able to develop interdepartmental relationships and form solid collaborations
• Able to confidently interact with all levels of management including senior management, physician leaders and others
• Demonstrated complex problem solving abilities
• Strong innovative skills
• Excellent interpersonal and multi-tasking skills
• Must be flexible, detail oriented and organized
• Demonstrated ability to work as part of a team, as well as independently with minimal supervision
• Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired.
• Knowledge of clinical trial budget and contract negotiation process and the ability to manage and oversee financial transactions.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,500.00 - $93,000.00 Annual Rate