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Posted Job TitleManager Research Project A/B (Department of Dermatology)Job Profile TitleManager Research Project AJob Description SummaryJob DescriptionManager Research Project A - The Clinical Studies Unit (CSU) is instrumental in the implementation and oversight of Dermatological Clinical Trials across the Department of Dermatology, Phase I-IV and Investigator Initiated Trials including multi-site protocols. Conducting complicated clinical trials in the areas of oncology and other medically complex disorders, while working collaboratively with multiple departments and outside parties.
The Manager position will report directly to the Director of Research Operations for Dermatology. The Manager will work closely with the Director in overseeing aspects of dermatological disorders clinical research portfolio being performed by the CSU. This includes assisting with study feasibility and selection, prioritization of the team's work, working closely with the CSU coordinators to ensure competitive activation and enrollment timelines. Additionally, on daily basis, the Manager oversee operations of the clinical trials, including study enrollment, adherence, regulatory compliance, timely completion of project milestones, supervision of research staff, and reporting to the sponsor. Support and management of staff (direct and/or indirect) to ensure compliance with study protocol and all regulatory standards. Also participate in the onboarding of new CSU personnel. Assist with all aspects of research including billing, patient visit, specimen processing, and data entry, query resolution.
Responsible for day to day management of complex projects conducted with collaborators both internal and external to Penn. With mentoring from the Director of Research Operations, the Research Project Manager will contribute to study design, methods, interpretation of results, and manuscript development and presentation. Plays a role in other dissemination activities related to project findings.
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 collaborates with peers from other Universities and funding agencies and FDA. Collaborate with departmental business administrators to oversee resources and budgets.
Provides contributions to presentations and manuscripts, including multiple drafts for review and dissemination.
Work with CSU team members to ensure accurate and timely data entry, query resolution, deviations and patient issues, identifying and addressing any issues including study recruitment and accrual. Communicating any specialized study budget needs to the Director of Operations, including any changes necessitated by a protocol modification and ensuring that the study team updates study trackers with study visit information and invoiceable items as needed by the Grants Team.
The manager will work closely with the CSU Director of Operations to develop and implement SOP's, report team study metrics, and communicate issues that may affect overall research with CSU Trials. Perform other duties as may be assigned.
Manager Research Project B
All the duties listed above plus the following:
With mentoring from the Director, the Project Manager will take a leadership role in developing the team's research strategy and ensuring scientific integrity of the study design during implementation. His/her purview will stretch beyond implementation to significant contributions to progress reports, data analysis plans, manuscript development, and presentations. He/she will co-author manuscripts for submission to peer-reviewed journals, with a lead role on clinical trial protocol manuscripts. He/she will develop grant proposals and lead subprojects, as needed.
Both Positions
Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.
Job Responsibilities
Assist in overseeing all aspects of the clinical research portfolio being performed by the CSU. This includes assisting with study feasibility and selection, prioritization of the team's work, working closely with the CSU coordinators to ensure competitive activation and enrollment timelines. They will also have primary study coordinator responsibility for Rare Dermatological Disorders and Translational Research studies for the CSU.
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 collaborates with peers from other Universities and funding agencies.
Work with CSU team members to ensure accurate and timely data entry, query resolution, deviations and patient issues, identifying and addressing any issues including study recruitment and accrual. Ensuring that the study team updates study trackers with study visit information and invoiceable items as needed by the Grants Team.
Manager is expected to troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work during absences or when a specific team member's workload exceeds capacity.Also to participate in the onboarding of new CSU personnel.
Work closely with the CSU Director of Operations to develop and implement SOP's, report team study metrics, and communicate issues that may affect overall research with CSU Trials.
Qualifications
Manager Research Project A: Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.
Manager Research Project B: Master's degree and 3 to 5 years of experience or an equivalent combination of education and experience is required.
A demonstrated ability to manage the scope, timelines, and budget of a large study, and excellent verbal and written communication skills are all required. Desirable skills include experience with randomized clinical trials.
This position is contingent upon funding.
Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$51,824.00 - $81,441.00 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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