Clinical Research Coordinator (CRC)
General Dynamics Information Technology
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Job summary
General Dynamics Information Technology (GDIT) is seeking a Clinical Research Coordinator to join the TBICoE team at Fort Bragg, NC. The CRC will coordinate TBICoE clinical investigations, ensure regulatory compliance, and manage consent processes for trauma-related brain injury studies.
The role requires a bachelor's degree in a related field, Human Subjects training, and 3+ years of clinical investigations experience. Onsite work with potential NACLC (T3) eligibility is involved.
Qualifications
- Bachelor's degree or higher in biology, psychology or related science.
- Human Subjects training completed.
- 3+ years clinical investigations experience.
- Knowledge of standard qualitative and quantitative data collection techniques.
- Good writing and analytical skills.
- Familiarity with social science research methodology.
- Ability to work comfortably with MS Office (Word, Excel, Outlook, PowerPoint).
Responsibilities
- Coordinates and assures integrity of TBICoE TBIC research activities with local, state, and federal regulatory requirements.
- Assists investigators with preparation and submission of protocols, consent forms and related documents to IRB and committees.
- Facilitates grant proposals and related documentation as needed.
- Maintains regulatory files for TBICoE clinical investigations.
- Communicates with participants, staff, regulatory affairs, data management, and investigators.
- Recruits, interviews, screens volunteers, and administers informed consent.
- Assists in data collection and analysis to evaluate eligibility and outcomes.
- Supports TBICoE program/Quality Improvement initiatives at the site.
- Collects, analyzes and interprets laboratory and clinical data.
- Documents adverse events and ensures protocol compliance and data integrity.
- Prepares and maintains volunteer databases/logs; performs data extraction and chart reviews.
- Trains incoming staff on study procedures and SOPs.
- Supports statistical analyses and data capture under direction of project leads.
- Adheres to confidentiality and privacy requirements; ensures security of records.
Skills
Education
Job description
Clinical Research, Informed Consent, IRB (Inactive), Participant Recruiting
GDIT’s Military Health Team is hiring a Clinical Research Coordinator (CRC) to join our current research team to help carry out Traumatic Brain Injury Research for the Traumatic Brain Injury Center of Excellence (TBICoE) located at Ft. Bragg in Fayetteville, North Carolina.
Regular
None
None
NACLC (T3)
Science and Research
Clinical Research, Informed Consent, IRB (Inactive), Participant Recruiting
None
3 + years of related experience
No
TBICoE unifies a system of TBI health care, reliably advancing the science for the warfighter and ready to meet future brain health challenges
Learn more about the mission HERE
The CRC is responsible for coordinating and assuring integrity of all activities associated with conducting TBICoE clinical investigations in the area of TBI. S/he will ensure compliance with local, state, and/or federal regulatory requirements.
- Coordinates and assures integrity of all activities associated with conducting TBICoE TBI clinical investigations as it relates to compliance with local, state, and/or federal regulatory requirements.
- Assists Principal / Associate Investigators in the preparation and submission of clinical protocols, consent forms and other documents to the scientific review committee, IRB and other regulatory organizations.
- Prepares requests for actions/proposals to include assisting with and providing coordination for grant proposal applications and their associated documentations and requirements as needed. Facilitates the flow and approval processes for relevant projects as needed or requested.
- Maintains regulatory files related to TBICoE clinical investigations.
- Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management and outside collaborators.
- Recruits, interviews, and screens TBICoE clinical research study volunteers, administers and obtains informed consent.
- Assists in the collection and analysis of data to evaluate volunteer eligibility for enrollment.
- May assist with TBI Program/Quality Improvement initiatives at their site.
- Assists in the collection, analysis and interpretation of 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 subject eligibility criteria, protocol compliance, omissions, and errors and submits these forms as required.
- Prepares and maintains written and electronic volunteer databases/logs.
- Performs data extraction and chart reviews of patients’ and/or research participant’s medical records or other relevant record/systems, as applicable.
- 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 on study forms (hardcopy and/or electronic).
- Prepares documents, under direction of project leads. Trains incoming staff on study procedures and SOPs.
- Assists with statistical analyses and descriptive data capture under direction of project leads. Works with the site senior clinical research director and other senior research leads for the collection, documentation and analysis of metrics to ensure a successful research program.
- Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
- US citizenship with the ability to pass a T3 security investigation.
- Bachelor's degree or higher in biology, psychology or related science.
- Must have Human Subjects training completed.
- 3+ years clinical investigations experience.
- Knowledge of standard qualitative and quantitative data collection techniques.
- Good writing and analytical skills
- familiarity with social science research methodology.
- Ability to work comfortably with computer software, including Microsoft Word, Excel, Outlook and PowerPoint.
- Master's degree preferred.
- Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred (must maintain Continuing Education credit sufficient to maintain certification when applicable).
- Prior experience within the DoW/VA systems of care preferred.
- Excellent communication skills, basic clinical acumen, knowledge of universal precautions, organizational skills and proficiency in research conduct.
- Ability to follow general instructions; work in a team environment.
- 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.
40
None
Onsite
USA NC Fort Bragg
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during virtual interviews. We reserve the right to take your picture to verify your identity and prevent fraud. By proceeding, you authorize the collection, processing, and use of your biometric data for identity verification and security purposes.
We are GDIT. A global technology and professional services company that delivers technology solutions and mission services to every major agency across the U.S. government, defense and intelligence community. Our 26,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50+ countries worldwide, offering leading mission-ready capabilities in AI, cloud, cyber and software development.
Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc.
Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
The likely salary range for this position is $57,824 - $78,200. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
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