Clinical Research Coordinator

Odyssey Systems Consulting Group; Fort Bragg (NC); On-site; USD 52,000 - 78,000; Full time

Job summary

Odyssey Systems Consulting Group is seeking a Clinical Research Coordinator to coordinate TBICoE clinical investigations, ensuring regulatory compliance and data integrity on-site at Fort Bragg, NC. The role supports investigators, manages documentation, and facilitates communications among study teams.

Qualified applicants will have 3–5 years of clinical investigations experience, U.S. citizenship, and a Bachelor’s degree or higher in biology, psychology, or related fields; Master’s preferred.

Qualifications

• U.S. citizenship required.
• Ability to obtain Secret clearance.
• Bachelor's or higher in biology, psychology, or related field; Master's preferred; Human Subjects training completed.
• 3–5 years clinical investigations experience; DoD/VA experience preferred.
• Certification as CRC/CCRP/CCRA preferred (CE credits to maintain certification).
• Excellent communication, clinical acumen, familiarity with universal precautions, strong organizational, writing and analytical skills.
• Knowledge of qualitative and quantitative data collection techniques; ability to follow detailed instructions; works well in teams and independently; familiarity with social science research methodology.
• Proficient with Microsoft Office; familiarity with basic statistical analyses.
• Adherence to confidentiality and privacy.
• Physical ability to sit/stand for long periods; lift up to 25 lbs.
• Office clinical and hospital environment; may encounter challenging patients.
• Willingness to travel locally, regionally and nationally; may include evenings/weekends.

Responsibilities

• Coordinate TBICoE clinical investigations with regulatory compliance.
• Assist investigators in preparing protocols, consent forms, and regulatory submissions.
• Prepare and coordinate grant proposals and associated documentation.
• Maintain regulatory files for TBICoE investigations.
• Communicate with participants, staff, regulatory affairs, data management, and investigators.
• Recruit, interview, screen volunteers and obtain informed consent.
• Assist in data collection/analysis for volunteer eligibility.
• Support TBICoE quality improvement or implementation science studies.
• Assist with data collection/interpretation of laboratory and clinical data and report significant findings.
• Document and report adverse events; ensure eligibility criteria and protocol compliance.
• Maintain written/electronic volunteer databases/logs.
• Perform data extraction and chart reviews of medical records.
• Ensure secure storage of research records; maintain inventory.
• Conduct data verification and resolve data queries.
• Prepare documents; train new staff on SOPs.
• Assist with statistical analyses and descriptive data capture under supervision.

Skills

Communication

Analytical skills

Teamwork

Attention to detail

Written communication

Data collection techniques

Confidentiality/privacy

Education

Bachelor's degree or higher in biology/psychology/related health/social science

Master's degree preferred

Human Subjects training completed

Tools

Microsoft Office

Job description

Position Summary

Odyssey is looking for a Clinical Research Coordinator to coordinate and assure the integrity of all activities associated with conducting Traumatic Brain Injury Center of Excellence (TBICoE) clinical investigations in TBI, brain health, and related outcomes. The candidate will ensure compliance with local, state, and/or federal regulatory requirements. This job is onsite at Ft Bragg, NC.

***Contingent upon contract award***

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 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.
• Assists with TBI Program/Quality Improvement initiatives or implementation science studies.
• 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 needed.
• 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.

***Contingent upon contract award***

Qualifications

Minimum Required Qualifications

• Citizenship: Must be a US citizen.
• Clearance: Ability to Obtain Secret.
• Education: Bachelor's Degree or higher in biology, psychology or related health/social science required. Master's degree preferred. Must have Human Subjects training completed.
• Years of Experience: 3-5 years clinical investigations experience required. Prior experience within the DoD/VA systems of care preferred.
• Certification: 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).
• Excellent communication skills, basic clinical acumen, knowledge of universal precautions, organizational skills and proficiency in research conduct are required.
• Knowledge of standard qualitative and quantitative data collection techniques; ability to follow general instructions; works effectively in a team and independently; demonstrates strong communication, writing and analytical skills. Familiarity with social science research methodology is required. Ability to follow detailed instructions.
• Must be able to work comfortably with computer software, including Microsoft Office and familiarity with basic statistical analyses.
• Adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
• Physical Capabilities: Must be able to sit and stand for long periods of time. Must be able to carry light items - up to 25 lbs.
• Work Environment: Office clinical and hospital environment. May encounter patients who are confused, agitated or abusive.
• Must be available to travel locally, regionally and nationally. May include hours in the late afternoons, evenings, and/or weekends, depending on study assessments and participant scheduling requirements.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities