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Regulatory Manager, Clinical Research Management Organization Regulatory

Employer
Georgetown University
Location
Washington D.C.

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Administrative Jobs
Academic Affairs, Research Staff & Technicians
Employment Type
Full Time
Institution Type
Four-Year Institution
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Regulatory Manager, Clinical Research Management Organization Regulatory, Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Regulatory Manager, Clinical Research Management Organization Regulatory, Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

Georgetown Lombardi Comprehensive Cancer Center (LCCC), part of Georgetown University Medical Center, seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community - guided by the principle of “cura personalis - “care for the whole person.”

The Regulatory Manager of Clinical Research Management Organization (CRMO) Regulatory, reporting to the CRMO Administrator, oversees the pre-activation process to ensure timely activation of trials and the negotiation of contracts and budgets, and serves as liaison among sponsors, investigators, the Office of Sponsored Research (OSR), IRB, and clinical operations team, to ensure timely activation of trials. Reporting to the CRMO Manager, the Regulatory Manager of CRMO Regulatory has duties that include but are not limited to:

Protocol Management
  • Oversee the timely activation of oncology clinical trials by developing and implementing efficient and effective standards and processes
  • Ensure the ongoing regulatory approval of all trials managed by the CRMO through utilization of appropriate tracking, issue resolution, and CTMS documentation
  • Ensure proper reporting of serious adverse events and protocol deviations as required by the GU IRB, the National Cancer Institute's Central IRB, the Clinical Research Committee/Protocol Review and Monitoring Committee, the Food and Drug Administration, and trial sponsors; and notify and inform physicians, clinical and research staff, and applicable affiliates of the impact on the research and patients enrolled at GU and its research partners
  • Oversee the close-out of each trial, ensuring the completion of all regulatory tasks and proper document archival
  • Develop and foster strong relationships with regulatory review bodies and study sponsors
  • Collaborate with Principal Investigators, clinicians, research staff, and other institutional officials to continually assess the LCCC clinical research trial portfolio and suggest adjustments when necessary
  • Maintain confidentiality standards for all potential and enrolled study participants; and comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations


Supervisory and Collaboration
  • Oversee the conduct of clinical research protocols by supervising all regulatory team members.
  • Direct and mentor team members in all aspects of their regulatory responsibilities
  • Plan, assign, and review work of staff to ensure that team objectives are met.
  • Hire, train, develop, and manage staff to ensure that a qualified team exists to meet group objectives
  • Actively engage in the performance management process; and set clear expectations that relate to the goals and objectives of the department
  • Provide frequent, constructive feedback
  • Complete the requirements of Georgetown's performance planning and evaluation system, following established deadlines with proper documentation
  • Support staff in their work and career development
  • Ensure staff have the necessary knowledge, skills, and abilities to accomplish goals
  • Establish and facilitate relationships with investigators, clinicians, staff, and community resources to ensure research needs are met within LCCC
  • Work closely with the CRMO Management team and staff to ensure effective administration of clinical trials, actively addressing issues with regulatory approvals, document creation, sponsor relationships, and overall study management from a regulatory perspective
  • Organize, participate in, and provide leadership and administrative oversight for meetings and committees
  • Remain current on legislation, rules, regulations, procedures, and development; and educate faculty and staff regarding change as it relates to clinical research
  • Monitor project development; propose and implement change when needed
  • Provide reports to leadership and make recommendations for efficiencies


CRMO Strategy and Administration
  • Work with Cancer Center and CRMO leadership to develop a sustainable CRMO that supports the clinical research mission of LCCC
  • Develop and implement policies and procedures for regulatory operations and assist with the development and enforcement of office wide CRMO policies
  • Attend and support appropriate LCCC, CRMO meetings and trainings

Membership and Protocol Participation
  • Oversee the approval processes for participating institutions, investigators, and research staff to open and/or continue participation in clinical research protocols from the National Clinical Trials Network (NCTN), industry, external agencies, consortiums and networks, and internal sources
  • Initiate and maintain all investigator and research staff registrations with the Cancer Therapy Evaluation Program (CTEP)


Professional Development and Special Projects & Tasks
  • Participate in special LCCC and CRMO projects as assigned
  • Maintain required knowledge to effectively perform the role by attending conferences, meetings, and necessary training.

Qualifications
  • Bachelor's degree
  • 5 to 7 years of relevant experience
  • 1 year of regulatory management experience providing direction on interpreting federal, state, and sponsor policies and regulations
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; - that is, Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • Strong communication and interpersonal skills, including good command of English language
  • Strong organizational and problem solving skills
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Good team leadership skills
  • Effective mentoring and training skills
  • Excellent customer service skills
  • Good judgment
  • Effective presentation skills
  • Ability to manage competing priorities
  • Strong software and computer skills, including MS Office applications
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Proficiency in use of Microsoft Word, Excel, and Power Point


Preferred qualifications
  • Master‘s degree in biological, health sciences or related field
  • Experience in clinical research settings - ideally, in cancer trials


Current Georgetown Employees:

If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.

Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or [email protected].

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.

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 wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.


To apply, visit https://apptrkr.com/2423087





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