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Requirements
Director, Clinical Research Operations Office - Georgetown University Medical Center
The Clinical Research Operations Office (CROO) works directly with stakeholders from the Georgetown University Medical Center (GUMC), Medstar Georgetown University Hospital (MGUH) and MedStar Health Research Institute (MHRI). This office ensures that all clinical trial activities for Non-oncology and Oncology are in compliance with federal regulations, including the Centers for Medicare & Medicaid Services. The CROO ensures proper and timely negotiation of clinical agreements, and the setup of studies in the clinical trial management and financial systems, including subsite obligations. The CROO is responsible for the timely billing and collection of industry based clinical trial activity. Federally funded studies, managed by Research Development Services (RDS) but requiring a Medicare Coverage Analysis (MCA) will be performed and provided back to RDS for grant submission.
Job Overview
The Director identifies potential compliance issues, and develops and implements solutions to problem areas that span the GUMC, MHRI and MGUH partnership. They work directly with leadership at GUMC, MGUH and MHRI; serve as a key liaison between those institutions with regard to clinical trial activity; and provide leadership to GUMC and MGUH investigators, clinical trial coordinators and administrative staff, and manages a team of six.
The Director is responsible for the administrative and operational facets of joint, clinical research at GUMC, MGUH and other MedStar entities when applicable; and identifies potential areas of growth for clinical research, and will actively seek out new business opportunities. They maintain and develop administrative relationships with all Industry sponsors for contract and financial activities; and joins Oncology and non-oncology teams on monthly calls to sponsors and CROs.
The Director updates, develops and implements clinical research policies to ensure that clinical research activities are compliant with relevant regulations; and creates training programs, and works directly with stakeholders across GUMC and GUH and other MedStar entities when applicable, to ensure that policies are enforced. They manage the CROO budget, and ensure appropriate budgets are forecast, monitored and reconciled for faculty and staff engaged in clinical research projects.
Work Interactions
The Director reports directly to the COO & AVP for GUMC, indirectly to the Dean of Research (DOR) for GUMC and MGUH representatives, including the MHRI President and MHRI Vice President for Research Operations.
The Director works directly with stakeholders across the GUMC, MGUH and other MedStar campuses when applicable, including senior leadership. They manage the following areas within the clinical trials activity process: legal/contracts, study documentation harmonization, Finance/budget-Medicare Coverage Analysis (MCA), and budget-negotiations - including understanding the needs of each department independently, compliant use of the clinical trials management system (CTMS), and compliant billing at MGUH for all industry trials. Additionally, the CROO trains new Clinical Research Coordinators in Georgetown process and billing compliance.
Qualifications
Master's degree - prepared in a science or healthcare related field with experience in research
7 years of experience managing clinical trials and/or in a clinical research environment; clinical research contract negotiations; developing and/or enforcing clinical research policies and procedures; and overseeing staff and managing human resource needs
Certification Healthcare Research Compliance.
Proven experience building external and internal relationships
Preferred requirements and qualifications should be listed separately here
Preferred qualifications
Familiarity with all aspects of sponsored clinical trials (but industry and federal)
Familiarity with computerized tracking tools /databases
Ability to independently navigate software database opportunities (budget or data related)
Effective management, problem solving, and interpersonal skills
Demonstrable ability to communicate effectively and work well with members of an academic medical center community and University officials
Strong service orientation and commitment to teamwork
Ability to manage multiple projects simultaneously and meet time sensitive deadlines
Work Mode: Hybrid (2 days on campus, 3 days telework). Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff and AAP positions can be found on the Department of Human Resources Mode of Work Designation .
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Submission Guidelines:
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EEO Statement:
Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law .
Benefits:
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website .
COVID-19 Vaccination Requirements:
The Georgetown University community is committed to our public health approach and the important role that vaccines play in contributing to the safety of our University and our broader communities. Georgetown University requires students, faculty, staff and visitors to be fully vaccinated against COVID-19 and to have received a COVID-19 vaccine booster shot when eligible, or to have an approved medical or religious exemption. This requirement applies to all faculty and staff, including teleworking employees. Complete details and updates can be found in the Coronavirus (COVID-19) Resource Center .