GDIT’s Military Health Team is hiring a Clinical Research Coordinator to support the TBI Center of Excellence (TBICoE) located at Ft. Bragg in North Carolina.
As the TBI Pathway of Care manager within the MHS, the Traumatic Brain Injury Center of Excellence promotes state-of-the-science care from point-of-injury to reintegration for service members, veterans, and their families to prevent and mitigate consequences of mild to severe TBI.
The Clinical Research Coordinator is responsible for coordinating and assuring integrity of all activities associated with conducting a clinical trial. S/he will ensure compliance with local, state, and/or federal regulatory requirements.
Coordinates and assures integrity of all activities associated with conducting a clinical trial as it relates to compliance with local, state, and/or federal regulatory requirements.
Assists Principal Investigators in the preparation and submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB and other regulatory organizations.
Maintains regulatory files related to TBICoE clinical investigations.
Communicates with research participants, clinical/provider staff, regulatory affairs and data management groups, laboratory and clinical investigators, management, and outside collaborators.
Reviews and analyses electronic medical records
Completes medical record data abstraction/extraction to include diagnostic and procedural information across multiple disciplines
Analyzes data to evaluate eligibility for study enrollment.
Analyzes and interprets laboratory and clinical data obtained during a medical evaluation, recognizes documentation inconsistencies and values, findings, and events that require clarification by providers or clinical investigators.
Assists with the documentation and reporting of adverse events, completes and reviews Case Report Forms for patient eligibility, protocol compliance, omissions, errors, and submits these forms as required.
Prepares and maintains written and electronic volunteer databases/logs.
Reviews the source document file for information such as verification of critical variables, entrance criteria, visit date, and lab data.
Ensures that research records are stored and secured properly, and that inventory and records are updated and properly maintained.
Conducts data verification as indicated, documents, assists the investigator and protocol coordinator with questions, may transcribe and resolve queries of data in case report forms (hardcopy or electronic).
Prepares documents, under direction of project leads.
Other duties consistent with the above responsibilities.
Bachelors degree or higher in biology, psychology or related science, or health information management is required.
Must have Human Subjects training completed.
2 years clinical trial or medical record abstraction experience required.
Knowledge of standard qualitative and quantitative data collection techniques
Knowledge of medical record organizational structure and medical rehabilitation processes.
Familiarity with social science research methodology is required.
US Citizenship required with the ability to pass a T3 security investigation.
Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred
Prior experience within the DoD/VA systems of care strongly preferred.
Skills & Attributes for Success:
Excellent communication skills
Ability to follow detailed instructions.
Ability to work in a team environment.
S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
Must be able to sit and stand for long periods of time.
Must be able to carry light items – up to 25 lbs.
May encounter patients who are confused, agitated, or abusive.
Office and clinical environment.
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 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.