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Posted Job TitleClinical Research Project Manager B (Department of Otorhinolaryngology)Job Profile TitleClinical Research Project Manager BJob Description SummaryThis position will report to the Director of Clinical Research and oversee all aspects of the Oto portfolio of clinical and translational research projects. This oversight includes assisting the Director in developing the department's short and long-term research strategy, establishing standard operating procedures and shared research resources, troubleshooting operational issues, supporting the safe and compliant conduct of clinical trials, and ensuring the department's reputation for excellence. The candidate will supervise and manage a team of Clinical Research Coordinators and Assistants, a compliance specialist, and all students and staff associated with the program. They will be responsible for recruiting, onboarding, and mentoring the members of this team. They will also delegate the regulatory and operational coordination of industry-sponsored and investigator-initiated drug, device, tissue, and observational clinical research projects to appropriate members of the staff and supervise their execution. The candidate will foster internal collaboration with other academic institutions, industry partners, funding agencies, community members, and other stakeholders. They will also work with the Director of Finance and the grants office to negotiate funding with industry and manage research program funding with a total operating budget of $40 million and grant funding of $8 million.Job DescriptionResponsible for strategic planning and day-to-day management of a complex and broad range of projects conducted with collaborators internal and external to Penn. With mentoring from the Principal Investigator, the Clinical Research Project Manager will lead in developing study protocols, writing grants, managing the detailed operations of projects, analyzing qualitative and quantitative data, cultivating close relationships with community partner organizations, and drafting/editing manuscripts for submission to peer-reviewed journals. He/she will help develop the team's research strategy and have ample opportunities to lead projects and co-author papers. Will be required to ensure that studies/research are conducted safely and according to protocol, provide supervision to educators and teams conducting the study/interventions, and collaborate with peers from other Universities and funding agencies. Will also be responsible for coordinating grant applications and interacting with funding administrators and the University Business Office. Provides significant contributions to presentations and manuscripts, including multiple drafts for review and dissemination. Plays a primary role in other dissemination activities related to project findings.
RESPONSIBILITIES/DUTIES
Oversee all aspects of human subjects' research operations, including personnel, regulatory compliance, industry interaction, and logistics for the department. Oversee initial and ongoing approvals for protocols from oversight entities, including IRB and FDA.
Supervise and manage a team of Clinical Research Coordinators and Research Assistants to facilitate the department's research activities and support its Investigators.
Ensure that studies are conducted safely, according to protocols, and in compliance with ICH-GCP, HIPAA, human subject protection, sponsor, University, School, and IRB policies. Provide training, assistance, guidance, and support to investigators, coordinators, and other research staff regarding regulatory compliance and good research practices.
Help develop the department's research strategy, establish and implement standard operating procedures and shared research resources, and contribute to selecting future research agendas. Review OCR Clinical Research metrics to ensure faculty and staff utilize the Clinical Trial Management System to capture data relevant to clinical trials appropriately.
Collaborate with departmental Investigators to develop fundable ideas. Work with organizational leaders on strategic planning to confirm resource needs are commensurate with the program's long-term growth.
Assist organizational leaders with general logistics management, such as planning and utilizing clinical, lab, office, and storage spaces for research teams at the various Penn entities (HUP, PMWS, etc.)
Foster collaboration with other academic institutions, industry partners, funding agencies, community members, and other stakeholders. Establish professional and effective relations with university colleagues. Build trust and inaugurate relationship networks both internal and external to Penn.
Perform additional duties as assigned.
Qualifications
A bachelor's Degree with 5-7 years of related experience or an equivalent combination of education and experience is required. A master's degree and 3-5 years of experience preferred. Experience with clinical research in an academic setting is also required. A leadership track record with real-world and supplemental educational experience is desired, as this position will manage a team of individuals across disciplines and physical locations. Some experience with regulatory requirements and processes is beneficial, along with experience working with both internal and external stakeholders in clinical research.
Working Conditions Office, library, computer room Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less; Typically standing or walking; Intermittently sitting/standing/stooping.
Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$61,046.00 - $85,000.00 Annual RateSalary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. Affirmative Action Statement
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