DVBIC SUMMARY: As a leader in traumatic brain injury research, the Defense and Veterans Brain Injury Center (DVBIC) serves active duty military, veterans and their beneficiaries with coordinated care throughout 23 Army, Navy and Veterans Affairs medical treatment centers.
General Dynamics Health Solutions' researchers and healthcare professionals treat and track more than 8,500 TBI patients a year to measure the impact of care on long term health and occupational outcomes.
Conducting 72 different clinical research studies - to include a 15-year congressional directed study - our experts educate political leaders, caregivers, clinicians, and the general public to provide and improve evidence-based, best practice TBI care for service members, veterans and their families
S/he 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.
- 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 patients' 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.
Non Primary Responsibilities:
- Other duties consistent with the above responsibilities.
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.
Must maintain Continuing Education credit sufficient to maintain both their clinical license and to meet medical facility specific Quality Assurance standards for credentialing when applicable.
2-3 years clinical trial experience required.
Prior experience within the DoD/VA systems of care strongly preferred.
Specialty Healthcare License preferred.
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.
S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.
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