Clinical Research Coordinator - Military veterans preferred
2019-01-02 General Dynamics Information Technology (www.gdit.com)
Ft Hood Texas United States
GDIT is HIRING a Clinical Research Coordinator in support of the Defense & Veterans Brain Inury Center (DVBIC). This person will responsible for coordinating and assuring integrity of all activities associated with conducting a clinical trial at the Intrepid Spirit Center/TBI Clinic at Ft Hood, TX. S/he will ensure compliance with local, state, and/or federal regulatory requirements.
Find our more about DVBIC HERE
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.
2+ years clinical trial experience required.
Prior experience within the DoD/VA systems of care strongly 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.
US citizenship is required with the ability to obtain a T3 security investigation.
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.
Bachelors Degree 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.