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 24,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services. General Dynamics Information Technology is an Equal Employment Opportunity and Affirmative Action employer.
***THIS POSITION IS NOT CURRENTLY FUNDED AND IS TIED TO A PENDING GDIT PROGRAM AWARD***
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.
to 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
and other documents to the scientific review committee, IRB and other regulatory organizations.
- Assists Principal Investigators in the preparation and submission of clinical protocols, consent forms,
- Maintains regulatory files.
clinical investigators, management, and outside collaborators.
- Communicates with research volunteers, regulatory affairs and data management groups, laboratory and
- Recruits, interviews, examines, counsels, and educates clinical trial volunteers, administer and obtain
report significant values, findings, and events that require prompt attention to clinical investigators.
- 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,
Forms for patient eligibility, protocol compliance, omissions, errors, and submits these forms as
- Assists with the documentation and reporting of adverse events, completes and reviews Case Report
criteria, visit date, and lab data.
- 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
updated and properly maintained.
- Ensures that research records are stored and secured properly, and that inventory and records are
with questions, may transcribe and resolve queries of data in case report forms (hardcopy or electronic).
- Conducts data verification as indicated, documents, assists the investigator and protocol coordinator
- Prepares documents, under direction of project leads.
- Reports statistical analyses and descriptive data from patient's study books to be used in research
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.
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.
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