GDIT’s Military Health Team is hiring a Clinical Research Coordinator/ Regulatory Coordinator to support the TBI Center of Excellence (TBICoE) located at Ft. Bragg in Fayetteville, 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 will be responsible for coordinating and assuring integrity of all activities associated with conducting a clinical trial. This person will ensure compliance with local, state, and/or federal regulatory requirements.
What You’ll Be Doing:
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 DVBIC clinical investigations.
Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management, and outside collaborators.
Recruits, interviews, examines, counsels, and educates clinical trial volunteers, administer and obtain informed consent.
May collect and analyze data to evaluate volunteer eligibility for enrollment.
May collect, analyze and interpret laboratory and clinical data obtained during a medical evaluation, report significant values, findings, and events that require prompt attention to 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.
Perform data extraction and chart reviews of patients’ medical records.
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.
Reports statistical analyses and descriptive data from patients study books to be used in research reports.
S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
What You’ll Need (required:
Bachelors Degree or higher in biology, psychology or related science.
2+ years clinical trial experience.
Knowledge of standard qualitative and quantitative data collection techniques.
Must have human subjects training.
Familiarity with social science research methodology.
US Citizenship required with the ability to obtain a T3 security clearance/ public trust.
What Would Be Even Better (preferred):
Prior experience within the DoD/VA systems of care strongly preferred.
ACRP or CCRP preferred.
Specialty Healthcare License preferred, not required.
Skills & Attributes for Success:
Ability to follow detailed instructions.
Excellent communication skills, basic clinical acumen, knowledge of universal precautions, organizational skills and proficiency in research conduct.
Must be able to sit and stand for long periods of time.
May encounter patients who are confused, agitated, or abusive.
Office and clinical environment.
What GDIT Can Offer YOU:
401K with company match
Customizable health benefits packages
Internal mobility team dedicated to helping you own your career
Challenging work that makes a real impact on the world around you
Full-flex work week
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.