General Dynamics Information Technology Clinical Research Coordinator/Nurse in North Charleston, South Carolina

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 will be in Fort Gordon - Georgia.

The DDEAMC Department of Clinical Investigation’s (DCI) mission is to promote, coordinate, support and oversee organized scientific inquiry in basic laboratory and clinical research using both human and non-human subjects. Our objective is to provide support for clinical research (human, animal, and laboratory-based research projects) and clinical trials conducted at DDEAMC and or conducted by DDEAMC staff in collaboration with other military, federal and/or civilian institutions/organizations. In support of this work GDIT is seeking a clinical research coordinator to perform the following tasks:

Preparation for Research Tasks

  • Assist investigators/researchers with protocol development.

  • Prepare key research documents to include, but not limited to, protocol preparation (writing, reviewing, and amending), regulatory submission documents, protocol training material, clinical study reports, and internal and external presentations.

  • Complete Human Research Subjects Protections training, investigator/researcher training appropriate to research role, and other research training required in accordance with DDEAMC policies and the organization’s Human Research Protection Plan/Program (HRPP).

  • Develop or provide assistance in developing study specific materials and tools necessary to appropriately train individuals involved in the conduct of identified research studies.

  • Conduct or provide assistance in conducting the required training. Document the training in accordance with according to DDEAMC policies. Maintain documentation of this training in accordance with DDEAMC policies.

  • Track and assist PIs in assuring that all persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations, DDEAMC policies, and sponsoring agency policies and procedures. Document date of training and signatures of study personnel trained on study specific training log.

  • Prepare research project materials (these project materials include, but are not limited to, enrollment logs, drug/device accountability logs, informed consent documents, and case report forms).

  • Develop and implement or assist PIs with developing and implementing recruitment strategies in accordance with IRB requirements and approval.

  • Ensure the adequacy of planning for study implementation. Work with PIs and research teams to prioritize project/study timelines ensuring overall timeline adherence and assists PIs in meeting milestones associated with their studies. Plan and coordinate the initiation of the research study and help establish the study operating policies and procedures.

Research Execution Tasks

  • Protect and assist PI with protecting the rights and welfare of all human research participants in accordance with Federal regulations, MEDCOM, DDEAMC HRPP, and sponsoring agency policies and procedures. Coordinate with PIs to ensure that clinical research studies are conducted in accordance with IRB approved protocols, Federal and Army regulations, MEDCOM and DDEAMC policies, and sponsor agency requirements. Document the training in accordance with DDEAMC policies. Maintain documentation of this training in accordance with DDEAMC policies.

  • Support, manage, facilitate, and coordinate the day-to-day research activities including problem-solving, communication, and routine protocol management.

  • Participate in and/or assist with subject recruitment activities and study procedures as required by specific protocols (including prescreening, subject screening, conducting study visits, tracking and distributing test articles, and educating subjects.

  • Participate in/Assist with the informed consent process including interactions with research participants and answering questions related to the study. Assure information is documented on the appropriate forms. Assure that amended consent forms are appropriately implemented and signed.

  • Coordinate participants’ tests and procedures; Collect, process, track, and ship protocol specific lab samples; Collect data as required by protocol

  • Assist in designing/developing processes, techniques, tools/equipment, testing devices required to support clinically based laboratory research projects.

  • Cooperate with and participate in DDEAMC compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to appropriate compliance office.

  • Assist PI, DCI, and DDEAMC in coordinating monitoring and reviewing research study audit findings and in implementing approved recommendations.

  • Collect, analyze and manage research/study information and data:

  • Initiate and conduct ongoing database analyses to support clinical objectives

  • Review scientific data and participate in reviewing ongoing summary data

  • Complete study documentation and maintain study files in accordance with regulations, DDEAMC policies, and sponsor requirements. Manage study documentation including confirming that required documents are archived and available

  • Present data and participate in the presentation of data at internal DDEAMC meetings.

  • Maintain detailed records of research conducted (produce accurate and timely reports as requested).

  • Establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other material.

  • Conduct and complete timely data management activities (including recording source data and keying in source data to study specific electronic data capture systems) in compliance with protocol specifications.

  • Assist PIs in preparing/reviewing publications related to active research projects; serve as co-author on publications on projects he/she is supporting as an Associate Investigator, Clinical research Coordinator or Research Team Member

  • Assist PIs in preparing/reviewing posters and podium presentations related to active research projects; may serve as co-author on posters and be a co-presenter in poster/podium presentations on projects he/she has supported as an Associate Investigator, Clinical research Coordinator or Research Team Member.

Post Research Execution Tasks

  • Assist PIs in preparing/reviewing publications related to closed research projects; serve as co-author on publications on projects he/she has supported as an Associate Investigator, Clinical research Coordinator or Research Team Member

  • Assist PIs in preparing/reviewing posters and podium presentations related to closed research projects; may serve as co-author on posters and be a co-presenter in poster/podium presentations in projects he/she has supported as an Associate Investigator, Clinical research Coordinator or Research Team Member.

  • Assist PIs in submitting accurate and timely closeout documents

  • Assist PIs in securing secure storage of study documents that will be maintained according to Federal, MEDCOM, and DDEAMC requirements.

Education

Bachelors Degree in a scientific discipline.

Qualifications

  • 2-5 years of related experience in scientific research and analysis.

  • Registered Nurse or Licensed Practical/Vocational Nurse (Current, Active, and Unrestricted Nursing License from the State of Georgia).

  • Must meet all licensing, educational, and credentialing requirements to function at DDEAMC as a Registered Nurse or Licensed Practical/Vocational Nurse.

  • Must remain in compliance with these licensing, educational, and credentialing requirements through the entire period of performance.

  • Minimum of four (4) years of demonstrated clinical research experience is required

  • Strong communication and interpersonal skills

  • Proficient in Computer Use (must be able to become proficient in using DDEAMC electronic systems)

  • Clinical Research Coordinator certification is preferred

  • US Citizenship is a prerequisite for this position per the contract requirements.

  • This position requires a favorable NACI investigation which is completed by the government after the offer letter has been executed.

  • This position requires credentialing at Dwight D. Eisenhower Army Medical Center.

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

Requisition ID2018-44507

of Openings1

Job FunctionScience and Engineering

Security Clearance LevelNone

Full/Part TimeFull Time