Clinical Research Coordinator

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

Duties include, but are not limited to:

• 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
• 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.

Certifications:   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).

 

Other requirements:

• 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, p