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Research Nurse Coordinator in San Diego at General Dynamics Information Technology

Date Posted: 3/14/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    San Diego
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    3/14/2019
  • Job ID:
    2019-53962

Job Description

General Dynamics Health Solutions is hiring an experienced Clinical Research Nurse to join our team in support of our client, Navy Medical Center San Diego (NMCSD) in California. 

“From the original tent dispensary established in 1914 to the modern facility of today, Naval Medical Center San Diego’s (NMCSD) mission has remained constant: provide the finest medical care in a family-centered environment to military service members, their families and those who served in the past”

Find out more about NMCSD HERE 

Preparation for Research Tasks

  • Assist investigators/researchers with protocol development.
  • Prepare and assist key research documents to include, but not limited to, protocol preparation (writing, reviewing, and amending), regulatory submission documents to EIRB,
  • Develop protocol training material, clinical study reports, and assist in development internal and external presentations and or reports.
  • Be a mentor for faculty, staff, residents and fellows on how to conduct research.ie CITI training , EIRB submissions
  • Complete Human Research Subjects Protections training (CITI), investigator/researcher training appropriate to research role, and other research training required in accordance with policies and the organization’s Naval Medical Center San Diego (NMCSD) Clinical Research Department (CID) 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 DOD HRPP policies. Maintain documentation of this training in accordance with NMCSD CID and DOD HRPP policies.
  • Track and assist PIs in assuring that all persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations, NMCSD CID, DOD HRPP 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, NMCSD CID, 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, policies, and sponsor agency requirements. Document the training in accordance with NMCSD CID, DOD HRPP policies. Maintain documentation of this training in accordance with 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 NMCSD CID and DOD HRPP compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to appropriate compliance office.
  • Assist PI, and DOD HRPP in coordinating monitoring and reviewing research study audit findings and in implementing approved recommendations.
  • Collect, analyze and manage research/study information and data:
  • Complete study documentation and maintain study files in accordance with regulations, DOD HRPP policies, and sponsor requirements. Manage study documentation including confirming that required documents are archived and available
  • Assist in presentation of data and participate in the presentation of data at internal research protocol 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 Nurse  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 Nurse 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, DOD HRPP requirements.

Job Requirements

  • 5+ years of related experience in scientific research and analysis.
  • 2+ years of clinical research experience (human subjects).
  • Current clinical competence within the past 2 years
  • Experience coordinating human research protocols within the past 2 years.
  • Must be a US citizen with the ability to obtain a favorable T3 security investigation prior to start date.
  • Possess a current unrestricted Registered Nurse (RN) license to practice as a nurse in any of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Territory of Guam or the U.S. Virgin Islands. 

Preferred Certifications:

  • Certification as a Clinical Research Associate (CRA) from the Association of Clinical Research Professionals (ACRP)  or
  • Possess current certification in American Heart Association (AHA) Basic Life Support (BLS) for Health Care Providers or American Red Cross (ARC) Cardio Pulmonary Resuscitation (CPR) for the Professional Rescuer. 

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.

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