About the Role:

The Clinical Research Coordinator (CRC) is responsible for coordinating and assuring integrity of all activities associated with conducting clinical investigations for the Traumatic Brain Injury Center of Excellence (TBICoE). The CRC will ensure compliance with local, state, and/or federal regulatory requirements.

Primary 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.

Non-Primary Responsibilities:

• Other duties consistent with the above responsibilities

Position Requirements:

Knowledge, Skills and Abilities: 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; work in a team; good communication, writing and analytical skills; familiarity with social science research methodology is required. Ability to follow detailed instructions. The incumbent must be able to work comfortably with computer software, including Microsoft Word, Excel, Outlook, and PowerPoint. S/he must adhere to legal, professional, and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Bachelor's Degree or higher in biology, psychology or related science required. Master’s degree preferred. Must have Human Subjects training completed. 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).

Minimum Experience: 3-5 years clinical investigations experience required. Prior experience within the DoD/VA systems of care preferred.

Required Licenses: None.

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.

Supervisory Responsibilities/Controls: None.

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. 

CITIZENSHIP AND CLEARANCE REQUIREMENTS:

• Must be eligible to work in the US.
• Must be able to pass a National Agency Check with Inquiries (NACI).

 CICONIX, LLC is an Equal Opportunity Employer.

• Competitive market-based salary, commensurate with experience and education
• Comprehensive benefits available (Medical, Dental, PTO, 401k etc).