Clinical Research Coordinator (CRC)
About The Position
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. Liberty in Fayetteville, North Carolina. The CRC is responsible for coordinating and assuring the 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. 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. 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. Trains incoming staff on study procedures and SOPs. 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.
Requirements
- 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.
- US citizenship with the ability to pass a T3 security investigation.
Nice To Haves
- 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 DoD/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.
Responsibilities
- 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.
Benefits
- variety of medical plan options, some with Health Savings Accounts
- dental plan options
- a vision plan
- 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
- full flex work weeks where possible
- a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave
- short and long-term disability benefits
- life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
