Clinical Research Coordinator (CRC)

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other Required:

NACLC (T3)

Job Family:

Research

Job Qualifications:

Skills:

Clinical Research, Informed Consent, IRB (Inactive), Participant Recruiting

Certifications:

None

Experience:

3 + years of related experience

US Citizenship Required:

No

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 Treatment Interventions for the Mental Health Needs of Warfighters With Traumatic Brain Injury (TIME) located at Marines Corps Base Camp Pendleton, in San Diego, CA.

The CRC is responsible for coordinating and assuring integrity of all activities associated with conducting (TIME) clinical investigations in the area of TBI. S/he will ensure compliance with local, state, and/or federal regulatory

requirements.

HOW YOU WILL MAKE AN IMPACT:

• Coordinates and assures integrity of all activities associated with conducting (TIME) 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 (TIME) 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 (TIME) 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.

• Ability to pass a T3 security investigation.

WHAT YOU'LL NEED TO SUCEED (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 comput