Clinical Trials Supervisor, Center for Translational Transplant Medicine – Georgetown University Medical Center

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Requirements

Clinical Trials Supervisor, Center for Translational Transplant Medicine – Georgetown University Medical Center

The Center for Translational Transplant Medicine (CTTM) is the research arm of the MedStar Georgetown Transplant Institute, one of the busiest abdominal transplant centers in the Atlantic region. Clinical trials transplant research requires constant management of both the study teams and also administrative and financial aspects of the trials. 

Job Overview

The Clinical Trials Supervisor oversees day-to-day clinical research operations for CTTM transplant trials and trials the Center partners with in other clinical departments such as gastroenterology and radiation oncology; and implement a diverse portfolio of research from investigator-initiated research studies to multicenter clinical trials. 

Major roles include but are not limited to:

• Direct oversight of clinical research staff, including human resource management tasks and onboarding/training
• Balancing staff bandwidth with appropriate study assignment
• Assuring that quality measures are maintained and protocols are conducted compliantly
• Leading the feasibility vetting process for new trials
• Evaluating and finding study efficiencies and assessing financial health of the portfolio
• Generating and managing data visualization dashboards to depict overall operational performance

Work Interactions

Reporting to the Assistant Research Manager in partnership with the Director, the Clinical Trials Supervisor collaborates with a variety of people and organizations at MGTI (MedStar)/CTTM (GUMC), including principal investigators, clinicians, clinical operations staff, administration, regulatory personnel, and contracts and grants managers. As well, they work closely with multiple Principal Investigators to assure compliant study conduct and effective study management by the clinical research team.

Qualifications

• Bachelor's degree in a scientific or related field
• At least 5 to 7 years of clinical research experience [Note: Equivalent combination of relevant education and experience may be substituted]
• In-depth knowledge of clinical trials, study management, protocol, and regulatory compliance (working knowledge of FDA, NIH, OHRP, and ICH GCP) and complex research visit operations
• Exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions
• Excellent demonstrated interpersonal, verbal, and written communication skills
• Ability to operate effectively in a changing organizational and technological environment (fluency with analytical tools and software platforms), as well as the fast-paced unpredictable clinical environment of transplant
• Ability to interpret and apply Georgetown and MedStar policies and federal, state, and local regulations
• Certified clinical research certification (SoCRA or ACRP) or must obtain certification within 6 months of hire
• Lead or project manager role in work history

Preferred qualifications

• Master’s degree in a related field
• Experience with clinical trials contracting and budgeting, industry, and non-industry
• Supervisory or leadership experience
• Demonstrated experience with quality audit and FDA inspection preparation, execution, and response
• Experience in risk mitigation management and drafting and operationalizing corrective action plans to show improvement and correction of shortcomings in clinical research operations

Work Mode: Hybrid. 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 positions can be found on the Department of Human Resources Mode of Work Designation .

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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:

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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 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 .