Clinical Research Coordinator (CRC)

General Dynamics Information Technology, Inc.; North Carolina; On-site; USD 60,000 - 75,000; Full time

Job summary

General Dynamics Information Technology, Inc. (GDIT) is seeking a Clinical Research Coordinator to support Traumatic Brain Injury research at the TBICoE site in Fayetteville, North Carolina.

The CRC will coordinate TBICoE clinical investigations, ensure regulatory compliance, and assist with study protocols, consent forms, and data management. Responsibilities include recruiting participants, obtaining informed consent, maintaining regulatory files, performing data extraction and chart reviews,

Qualifications

• 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.

Responsibilities

• Coordinate and assure integrity of TBICoE TBI clinical investigations in regulatory compliance.
• Assist Investigators with preparation/submission of protocols, consent forms and documents to IRB and regulatory bodies.
• Support grant proposal applications and related documentation and approvals.
• Maintain regulatory files related to TBICoE clinical investigations.
• Communicate with research participants, staff, regulatory affairs and data management groups.
• Recruit, interview, and screen TBICoE study volunteers and obtain informed consent.
• Assist in data collection/analysis to evaluate volunteer eligibility for enrollment.
• Assist with data extraction, chart reviews, and data verification for study forms.
• Prepare and train staff on study procedures and SOPs.
• Assist with statistical analyses and descriptive data capture under supervision.

Skills

Excellent communication skills

Strong writing and analytical skills

Team player

Education

Bachelor's degree or higher in biology, psychology or related science

Tools

Microsoft Word

Excel

Outlook

PowerPoint

Job description

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.

MISSION:

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

HOW YOU WILL MAKE AN IMPACT:

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.

WHAT YOU'LL NEED TO SUCCEED (REQUIRED):

• 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.

WHAT WOULD BE EVEN BETTER (PREFERRED):

• 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.

SKILLS & ATTTIBUTES FOR SUCESS:

• 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.

ENVIRONMENTAL DETAILS:

• 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.

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