This site uses cookies. To find out more, see our Cookies Policy

Clinical Research Coordinator (Human Subjects) in Camp Lejeune at General Dynamics Information Technology

Date Posted: 2/13/2019

Job Snapshot

  • Employee Type:
  • Location:
    Camp Lejeune
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

GDIT's Military Health Solutions is seeking a Clinical Research Coordinator (CRC) in support of the Naval Medical Center Camp Lejeune, NC. The Clinical Research Coordinator is responsible for providing research coordinator support for Institutional Review Board (IRB) approved research protocols. The position will coordinate human clinical research activities of specific research protocols as assigned by the Clinical Investigator Department Head (CIDH). 

Primary Responsibilities Include:

  • Responsible for coordinating the research activities of assigned IRB-approved study protocols. Supports the clinical investigations department and is accountable for research matters to the PIs of each assigned research protocol.
  • Provides support to each protocol in accordance with written Federal, DoD, DON, BUMED, and NMCCL regulations, policies, and procedures.  Ensures all studies performed are in accordance with the approved protocol and applicable regulations. 
  • Works closely with the Research Administration Officer (RAO) to compile the list of and order the required study materials, equipment, and supplies as specified in the research protocol.
  • Coordinate with Principal Investigator to ensure all resources are available as necessary to meet research time-lines.
  • Personal contacts are with patients, their families and/or significant others, providers, clinical nurses, department heads, corps staff, respiratory staff and clerical staff. The CRC will also have frequent contacts with research personnel from government agencies, granting agencies and industry sponsors. Contacts will be for the purpose of consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to elicit positive behavioral response such as guiding patients through a research protocol.  Shall report data on research patients in accordance with IRB-approved protocols and applicable regulations.
  • Recruit and screen patients using protocol inclusion/exclusion criteria, and refer eligible patients to the PI for final evaluation, as dictated by the IRB-approved protocol.  
  • Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.
  • Provide education to patients on compliance, possible side effects, drug interactions, and the importance of contacting the coordinator for any possible adverse events. 
  • Coordinate the performance of phlebotomies, electrocardiograms, intravenous infusions, vital signs, specimen collection, and other procedures as required by the protocol.
  • Must be proficient in appointment booking, coordinating laboratory studies, x-rays, and other tests
  • Assign appropriate patient randomization number per protocol design
  • In collaboration with the Pharmacist, verify that drugs are correctly dispensed as per protocol.
  • Process and prepare specimens for lab analysis and shipping. Observe universal precautions and Occupational Safety and Health Administration (OSHA) standards when processing or handling specimens. 
  • Obtain laboratory results and consult with the PI for follow-up care.
  • Report adverse events to governing agencies and sponsors as required by protocol and regulations.
  • Evaluate compliance of research subject and complete documentation of status and progress. Maintain detailed documentation of the research study as required by the protocol and the Investigator’s File Binder/Regulatory Binder.
  • Assists with amendment creation and review, reporting protocol deviations or violations, reporting Serious Adverse Events and UPIRTSO, submitting continuing review documents, and final reports.
  • Attend conferences and other meetings as required by the protocol, the PI, or sponsoring agency. Attends seminars, workshops, and conferences in order to gain insight into new trends in human research, improve effectiveness and efficiency in their primary duties, and to learn new approaches for the application of federal regulations.
  • Work is performed in ambulatory care spaces, in-patient wards, and outlying clinics.
  • Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.

Job Requirements

  • 2+ years of experience coordinating research protocols as a certified research coordinator.
  • Certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) is highly desired.
  • Knowledge of medical terminology and treatment concepts.
  • Knowledge of applicable Department of Defense (DoD), Department of the Navy (DoN), Health and Human Services (HHS), Food and Drug Administration (FDA) policies, guidelines and regulations, and federal and state laws pertaining to the use of human subjects in research - to include the use of investigative drugs/devices.  
  • Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and IND/IDE requirements. 
  • Demonstrated ability to interact professionally and effectively with investigators, sponsors and multidisciplinary teams. Sufficient personal and professional skills to interact professionally and effectively and conduct collaborations with investigators, sponsors, and multidisciplinary teams and to participate with higher authorities and colleagues in a variety of settings. Skill in delivering recommendations that may be disputed to a varied group of managerial and professional staff.
  • Ability to communicate orally and in writing with all levels of the organization and to teach in formal and informal settings. Effective, accurate, timely, and tactful communication are essential to the proper function of the department.
  • Skill in using desktop and networked computer software, to include intermediate or advanced level competencies with Microsoft Windows and the Microsoft Office suite (Outlook, Word, Excel). Ability to learn and master proprietary software such as EIRB, ProIRB, PROMIS and IRBNet protocol data management software, as these programs are critical to the day-to-day operations of the CIDH.
  • Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, and be adept at prioritizing and multitasking. Must be comfortable with changing conditions and research workload.
  • US citizenship is required with the ability to pass a T3 security investigation and clear occupational health requirements. 

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.