GDIT's Military Health team is hiring a Clinical Trial Manager to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.
Manage single site and multicenter clinical studies both inside and outside the continental United States; manage other entities supporting the conduct of clinical trials to ensure all sponsor required trial monitoring is conducted and all deliverables are received, providing updates to leadership and sponsor’s representative through Gantt Charts or other acceptable tracking tool
Write, review, and/or revise trial specific standard operating procedures or study specific procedures, including standard operating procedures for specific research, pharmacokinetic assays, or other testing not described in the trial procedure manual
Provide regulatory inspection notifications and any report generated from an inspection or external audit to the sponsor
Review and revise protocols, informed consent forms, and other study related documents to include the initial versions and amendments. This is including, but not limited to the informed consent, Investigators Brochure, source documents, study procedures manual, study specific procedures, pharmacy manual, FDA Form 1572, clinical trial agreement(s), and transfer of regulatory obligations documentation (FDA Form 1571 listing the obligations transferred).
Coordinate, lead, or participate in study working groups, which include protocol development working groups, risk assessment groups, product or manufacturing working groups, and other working groups established by the integrated product team, and write or review the associated minutes
Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities
Prepare and/or review sample handling instructions to include volume of the sample, tube or container for collecting the sample, sample collection time points, special instructions for processing and storing samples, instructions on how and where to ship specimens, and documentation requirements for sample accountability, which may be part of Trial Procedure Manuals or stand-alone instruction manuals, standard operating procedures, or study specific procedures
Develop study specific grading criteria, and use them to conduct viability assessments during site qualification visits to document whether or not a proposed clinical site and principal investigator meet the requirements for execution of the proposed clinical trial
Assist in investigator selection, which includes documenting the qualifications and experience of the investigator with, at a minimum, the curriculum vitae, current Good Clinical Practices and Human Subjects Protection training certificates, and the medical license (if applicable)
Assist in monitor selection, which includes documenting the monitor’s qualifications and experience
This position is full-time, on-site at Ft Detrick, MD.
Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
8 years of related experience within clinical research, managing clinical trials
Must be highly organized, detail oriented, and perform independently.
Have excellent Microsoft Excel Spreadsheet skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
Some travel may be required.
WHAT GDIT CAN OFFER YOU:
Challenging work that makes a real impact on the world around you
Internal mobility team dedicated to helping you own your career
401K with company match
Diverse, highly collaborative teams
Professional development, education assistance, certification and training opportunities
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.