657473 - Clinical Research Coordinator


Leidos's Military & Veterans Health Solutions Group is seeking a Clinical Research Coordinator to support our operations at the Naval Medical Center in Portsmouth, VA (NMCP). The Clinical Research Coordinator will coordinate and conduct human clinical research in conjunction with the Principal Investigators (PI) of Institutional Review Board (IRB)-approved research protocols primarily within the Nursing Research Department.

Specific responsibilities include:

* Coordinate the research activities of assigned IRB-approved study protocols. Protocols will include pediatric and adult subjects, animals and human anatomical specimens (including cadavers).

* Be accountable for research matters to the PIs of each research protocol.

* Support PIs 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.

* Exercise independent judgment to determine appropriate action and priorities in the performance of duties. Work will be evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness.

* Input research data into the appropriate databases.

* Recruit and screen subjects using protocol inclusion/exclusion criteria

* Administer and collect questionnaires from patients and healthcare providers at study sites.

* Observe patient care teams and complete teamwork questionnaires at study sites.

* Assign appropriate subject identification number per protocol design.

* Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.

* 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.

* Conduct telephone, face-to-face interviews or mail information for follow-up visits.

* Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the PI's File Binder/Regulatory Binder.

* In collaboration with PIs, prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol.

* Process and prepare specimens for laboratory analysis and shipping.

* Interact on a regular basis with the PI regarding the conduct of the research study.

* With approval, attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.

* Return telephone calls from research participants in an efficient and timely manner and documents interactions appropriately.

* Observe safety regulations when working in ambulatory care spaces and inpatient wards such as the use of Government provided personal protective equipment (PPE).

* Provide other administrative duties that are within the scope of work.


Candidates must possess one of the following:

* Bachelor's Degree from an accredited college or university and a minimum experience of 2 years as a Clinical Research Coordinator within the past five years.

* Current 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).

Candidates must also possess:

* Completed human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date.

* Proficiency in medical record reviews and searches. In order to accomplish this task, personnel must have experience in the use of clinical computer systems such as CliniComp (Essentris), Cerner (MHS-Genesis) or SPSS.

* Ability to perform work requiring concentration, periods of standing and walking on a regular basis; must work well under pressure, in often changing conditions and research workload.

* Favorably completed National Agency Check with Law and Credit (NACLC) or T3/T3R equivalent investigation.

* U.S. Citizenship

Ideal Skills:

* Completed human protection training developed by the Collaborative Institutional Training Initiative (CITI).

* Demonstrated proficiency in appointment booking and other participant interactions as well as writing and editing to assist PIs in preparation of their manuscripts, scientific abstracts, and/or research presentations.

* Experience in a human subject research setting and experience in the US federal government system is highly desired.

Work Location:

* Personnel may be exposed to contagious diseases, infections and flying debris, requiring the wearing of personal protection equipment such as scrub attire, gloves, masks, and eye protection.

* Personnel will participate in the Government's Blood-borne Pathogen Orientation Program. Personnel will also participate in all required annual training and in periodic training for all procedures that have the potential for occupational exposure to blood-borne pathogens.

* Personnel will comply with infection control guidelines to include the proper handling, storage, and disposal of infectious wastes and the use of universal precautions to prevent the spread of infections.

* Work is to be primarily performed on Government installations. Up to 10% CONUS travel may be required.


Leidos Overview:

Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company's diverse employees support vital missions for government and commercial customers. 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. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

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