Senior Research Coordinator, Clinical Research Operations Office - Georgetown University Medical Ce
Senior Research Coordinator, Clinical Research Operations Office - Georgetown University Medical Center
The mission of Georgetown University's Clinical Research Operations Office (CROO) is to provide services to Georgetown researchers, assisting with study start-up and administration; Patients and the general public, providing up-to-date information about ongoing clinical studies at Georgetown University Hospital Medical Center (GUMC); and Sponsors, helping them identify GU investigators for participation in their research.
The Senior Research Coordinator is a team lead for the overall operational management of clinical research activities of Clinical Research Operations Office (CROO), with direct responsibility for implementing a diverse portfolio of research activities for studies spanned across multiple disciplines. S/he performs expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, leadership skills, effectively working with a variety of people and organizations GUMC (clinicians, investigators, clinical staff, administration, regulatory, contacts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), and exhibiting an in depth knowledge of specific programs. Reporting to the Clinical Research Manager and Principal Investigator, the Senior Research Coordinator has duties that include but are not limited to:
Coordination and Support
- Provides Clinical Research Coordinator (CRC) support to multiple departments and projects conducted at GUMC.
- Coordinates with sponsor regarding site management, data review, and query resolution issues - providing guidance and suggestions for resolution.
- Provides strategic and operational regulatory guidance to internal project teams.
- Completes and submits case report forms on as close to a "real time basis" as possible.
Training and Competency
- Works directly with Manager of Central Research Support Services to provide mentorship and training for junior level CRC roles.
- Assists in the completion of CRC competency checklists under the supervision of the Manager of Central Research Support Services.
- Networks and builds trusting relationships with potential GUMC CRC pool users.
- Participates in GUMC activities to promote the CRC pool.
- Ensures all research participants encounters are updated as appropriate and within 24 hours in OnCore Clinical Trial Management System (CTMS).
- Collects, enters, and analyzes subject data, and compiles reports using OnCore CTMS.
- Provides monthly enrollment numbers to the Manager of Central Research Support Services.
- Submits study specific time sheets weekly to the Manager of Central Research Support Services.
- Attends monthly CROO meetings and weekly study team meetings.
- Completes and maintains GCP and Human Subjects Protection Training.
- Bachelor's degree in a scientific or related field
- 3 - 5 years of clinical research experience
- In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures
- Significant clinical trial management experience including regulatory and compliance responsibilities
- 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
- Strong working knowledge of FDA. NCI, OHRP and/or ICH GCPs
- Ability to interpret and apply GUMC policies and federal, state, and local regulations
- Master's degree in related field
- Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CRAA) certification
- Fluency in spreadsheet software - ability to develop complex spreadsheets independently
- Demonstrated skills in audit preparation, execution, and follow-up
- Experience in risk management regarding study objects, federal and non-federal sponsors and regulating bodies
- Experience with grant procedures, contact generation and subcontracting, preferably at GUMC - strong preference for supervisory experience
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