Job Description
GDIT’s Military Health Solutions is HIRING a Clinical Research Coordinator to support Traumatic Brain Injury Research within our military population. The CRC will be working with the Defense & Veterans Brain Injury Center (DVBIC) located at the Naval Medical Center in San Diego, California!
As the traumatic brain injury (TBI) Pathway of Care manager within the Military Health System (MHS), the Defense and Veterans Brain Injury Center promotes state-of-the-science care from point-of-injury to reintegration for service members, veterans, and their families to prevent and mitigate consequences of mild to severe TBI.
Learn More About DVBIC HERE
The Clinical Research Coordinator is responsible for coordinating and assuring integrity of all activities associated with conducting a clinical trial. S/he will ensure compliance with local, state, and/or federal regulatory requirements.
Primary Responsibilities:
- Coordinates and assures integrity of all activities associated with conducting a clinical trial as it relates to compliance with local, state, and/or federal regulatory requirements.
- Assists Principal Investigators in the preparation and submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB and other regulatory organizations.
- Maintains regulatory files related to DVBIC clinical investigations. Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management, and outside collaborators.
- Recruits, interviews, examines, counsels, and educates clinical trial volunteers, administer and obtain informed consent. May collect and analyze data to evaluate volunteer eligibility for enrollment.
- May collect, analyze and interpret 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 Case Report Forms for patient eligibility, protocol compliance, omissions, errors, and submits these forms as required.
- Prepares and maintains written and electronic volunteer databases/logs. Perform data extraction and chart reviews of patient’s medical records.
- Reviews the source document file for information such as verification of critical variables, entrance criteria, visit date, and lab data.
- 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 in case report forms (hardcopy or electronic).
- Prepares documents, under direction of project leads. Reports statistical analyses and descriptive data from patient's study books to be used in research reports.
Education
- Bachelor's Degree or higher in biology, psychology or related science required.
- Must have Human Subjects training completed.
- Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred.
Qualifications
- 2+ years clinical trial experience required.
- 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.
- S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
- US citizenship is required with the ability to obtain and maintain a favorable T3 security investigation.
- Prior exerience supporting DVBIC is preferred.
- Prior experience within the DoD/VA systems of care strongly preferred.
- Must be able to sit and stand for long periods of time.
- Must be able to carry light items – up to 25 lbs.
- May encounter patients who are confused, agitated, or abusive.
For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.