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Clinical Research Coordinator with Security Clearance

Company: General Dynamics IT
Location: Portsmouth
Posted on: September 6, 2018

Job Description:

With more than 8,000 health experts, clinicians and advisors, General Dynamics Health Solutions' personnel provide vital expertise and project management support to help organizations research, diagnose and treat varying healthcare issues to improve outcomes. Our program and project management professionals supply the necessary expertise and administrative support to keep pace with industry demands. Relying on our specialized scientists, technicians and providers, organizations gain the necessary clinical staff to meet organizational needs and advance medical research. This position is responsible for providing research coordinator support for Institutional Review Board (IRB) and Institutional Animal Care and Utilization Committee (IACUC) - approved research protocols. This position organizationally supports the Department Head of the CID, Directorate for Professional Education, NMCP. The individual will coordinate activities of NMCP's Combat Trauma Research Group (CTRG), including human clinical research and animal research in conjunction with the group's Director and Principal Investigators (PI) of approved research protocols. * Responsible for coordinating the research activities of assigned IRB and IACUC-approved study protocols. Specific protocols that require the CRC's support will be determined by the Department Head of CID in consultation with the PI. Protocols will include both pediatric and adult patients * Supports the Department Head of CID and is accountable for research matters to the PIs of each research protocol. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness. * Provides support to the Department Head of CID and the Principal Investigators of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties. * 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 Investigational New Drug (IND) requirements. * Ensures all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations. * Works closely with the Senior Research Technician/Supply Purchase officer in ordering study materials, equipment and/or research animals as specified in the research protocol in accordance with CID IACUC policies and animal facility standard operating procedures. * Coordinate with Principal Investigator to ensure all resources are available as necessary to meet research timelines. * Personal contacts are with patients, their families and/or significant others, providers, clinical nurses, nursing department head, 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. Refer eligible patients to the PI for final evaluation. * 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. * Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol. * Will be adept in the use of managerial skills, communication skills and leadership skills as the coordinator of complex human and animal research protocols. * Must be proficient in appointment booking, coordinate laboratory studies, x-rays, and other tests. * Assign appropriate patient randomization number per protocol design. * In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol. * Maintain accurate documentation record of drugs received. * Process and prepare specimens for lab analysis and shipping. * Observe universal precautions and OSHA standards when processing or handling specimens. * Obtain laboratory results and consult with the PI for follow-up care. * Collect data in a timely and accurate manner and submit information to coordinating centers as required. * 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. * Prepare reports and other correspondence regarding the research protocol for IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol. * Interact on a regular basis with the PI and Research Scientist regarding the conduct of the research study. * If properly certified (LVT-licensed) may extract blood or place bandages on animal subjects, assist with the restraint and handling of laboratory animals, surgical preparation, induction and maintenance of anesthesia, operation of physiologic monitoring equipment, collection and recording of anesthetic and experimental data and parameters. * Assists with amendment creation and review. * Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency. * Work is performed in ambulatory care spaces inpatient wards, and the vivarium, all of which present some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons. Education A Bachelor's Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Master's Degree or certification as a Registered Nurse may be given preference during the technical evaluation. * A BS/AAS is preferred in animal science, zoological, biological sciences, veterinary technology specifically related to Laboratory Animal Research required. Bachelor with certification as ALAT, LAT or LATG with AALAS may be given preference during the technical evaluation. Qualifications * Must be a US Citizen. 2-5 years of related experience in scientific research and analysis. A minimum of two years' experience coordinating research protocols (four years preferred) as a certified research coordinator OR 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). A minimum of two years' experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification may be given preference during the technical evaluation. Working knowledge of PHS, OLAW, AWA, USDA, Guide and AAALAC Working knowledge of IACUC rules and regulations. Experience with submission of protocol amendments Experience with exotics, small animal ruminants, and large animal models. Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research. 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 Investigational New Drug (IND) requirements Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings. Skills in counseling, guidance, and maintaining interpersonal relationships. Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date and additional protocol specific training as required. * This position requires a favorable NACLC investigation which is completed by the government after the offer letter has been executed. 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. #DICE #HCSDCJ

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Keywords: General Dynamics IT, Portsmouth, Clinical Research Coordinator with Security Clearance, Healthcare, Portsmouth, Virginia

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