Clinical Research Coodinator

Clearance Level
Secret
Category
Research
Location
Camp Pendleton, California

REQ#: RQ130449

Travel Required: None
Public Trust: NACLC (T3)
Requisition Type: Regular

GDIT is hiring a Medical Record Abstractor/ Clinical Research Coordinator to support a grant funded research project for the Traumatic Brain Injury Center of Excellence (TBI CoE) (formally know as Defense & Veterans Brain Injury Center DVBIC) located at Marine Corps Base Camp Pendleton, CA!

TBI CoE promotes state-of-the-science traumatic brain injury care from point-of-injury to reintegration for service members, veterans and their families. Our goal is to help the Defense Health Agency provide optimal patient outcomes, leading to a medically ready and a ready medical force.

Learn More About the TBI CoE Mission HERE

The Medical Record Abstractor/ Research Coordinator is responsible for coordinating and assuring integrity of all activities associated with conducting a clinical trial and/ or human subjects research. S/he will complete investigations under the supervision of the lead of the project. S/he will participate in many aspects of research including data collection, organization, literature reviews, structured interviews, analysis and interpretation of basic data and will assist with the preparation of technical reports, summaries, and protocols. S/he will ensure compliance with local, state, and/or federal regulatory requirements.

Responsibilities:

  • Coordinates and assures integrity of all activities associated with conducting clinical investigations/ human subjects research as it relates to compliance with local, state, and/or federal regulatory requirements.
  • Assists Principal Investigators in the preparation and submission of clinical protocols and other documents to the scientific review committee, IRB and other regulatory organizations
  • Assists the development of study manuals.
  • Maintains regulatory files for TBI CoE clinical investigations.
  • Communicates with clinical/provider staff, regulatory affairs and data management groups, laboratory and clinical investigators, management, and outside collaborators.
  • Reviews and analyses electronic medical records
  • Utilizes working knowledge of ICD-9 and ICD-10 coding to analyze electronic medical records.
  • Completes medical record data abstraction/extraction to include diagnostic and procedural information across multiple disciplines.
  • Analyzes data to evaluate eligibility for study enrollment.
  • Analyzes and interprets laboratory and clinical data obtained during a medical evaluation, recognizes documentation inconsistencies and values, findings, or events that require clarification by providers or 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.
  • 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.
  • Participates in data collection and/or abstraction, data entry and organization, literature reviews, and structured interviews; may.
  • Assists with the preparation of technical reports, summaries, and protocols.
  • Maintains clear and accurate records, inventories and logbooks.
  • Verifies and corrects data entry for research projects, supports senior staff in quality control and provides trouble shooting.
  • Provides written updates to senior staff.
  • Other duties consistent with the above responsibilities.

Qualifications:

  • Bachelor's Degree or higher in biology, nursing, psychology, occupational therapy, social work, physical therapy or related allied health science, or health information management required.
  • 3+ years clinical trial or human subjects research experience or medical records abstraction is required.
  • Must have Human Subjects training completed.
  • Knowledge of standard qualitative and quantitative data collection techniques; familiarity with social science research methodology, and knowledge of medical record organizational structure and medical rehabilitation processes is required.
  • Knowledge of the design of patient electronic health record systems, preferably to include AHLTA, VISTA, MHS GENESIS and/or ESSENTRIS.
  • Knowledge of standards for storage of protected health care information. Ability to follow detailed instructions. S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
  • US Citizenship with the ability to obtain a T3 security investigation.

Preferred Qualifications:

  • Master’s Degree preferred.
  • TBI related experience in healthcare or rehabilitation setting in area of training preferred.
  • Prior experience within the DoD/VA health systems of care strongly preferred.
  • Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred.

Skills & Attributes for Success:

  • Ability to follow general instructions, work in a team ; excellent writing and analytical skills.
  • Excellent communication skills, organizational, and analytical skills and proficiency in research conduct.
  • Must be able to carry light items – up to 25 lbs. May encounter patients who are confused, agitated, or abusive.

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About Our Work

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

COVID-19 Vaccination

GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.

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.