Surveillance Supervisor - San Diego, United States - General Dynamics Information Technology

General Dynamics Information Technology

Verified Company

San Diego, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Type of Requisition:
Regular

Clearance Level Must Currently Possess:
None

Clearance Level Must Be Able to Obtain:
Secret

Suitability:
Public Trust/Other

Required:

Job Family:
Research

Job

Qualifications:

Skills:
Clinical Research, Clinical Trials, Following Protocols, Surveillance

Certifications:

Experience:

2 + years of related experience

US Citizenship

Required:
Yes

Job Description:

GDIT is seeking a Surveillance Supervisor in support of the Naval Health Research Center (NHRC) Operational Infectious Disease (OID) Field Surveillance and Laboratory Research Services.

As the Navy hub for the Armed Forces Health Surveillance Center, the NHRC Operational Infectious Diseases Directorate conducts on-going, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses.

This position will provide support services for operational infectious disease surveillance, accredited clinical laboratory testing, diagnostic evaluations, clinical research support and scientific research services.

Specific Responsibilities:

Provide supervisory support for surveillance of operational infectious diseases that affect DoD personnel in coordination with federal agencies, local governments, research organizations, and universities at locations around the world (coordination will be completed by the Government).
Provide operational support for diagnostic evaluations, clinical studies, and/or clinical trials supported by NHRC and sponsored by Federal Agencies or private companies.
Maintain Good Clinical Laboratory Practices standards in performance of laboratory testing.
Maintain the existing Government approved QA/QC (quality assurance/quality control) program that meets accreditation standards (such as CAP
College of American Pathologists) and improves the safety and quality of the laboratory.
In cases of nation emergency or infectious disease outbreaks, employee may be required to support efforts deemed appropriate in their position. Given the rapid response that may be required and emergency nature of the situation, significant overtime may be required during these periods.
Provide support for protocol‐driven scientific research addressing infectious diseases
Input research data into database.
Report adverse events to the IRBprotocol PI for submission to governing agencies and sponsors as required by protocol and regulations.
Conduct telephone or facetoface interviews and mail government approved information for followup visits.
Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigator's File Binder/Regulatory Binder.
In collaboration with OID, PIs, and assigned medical monitor, 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.
In collaboration with key research personnel and investigators, process and prepare specimens for lab analysis and shipping.
Interact on a regular basis with the PI regarding the conduct of the research study.
Attend conferences (approved by the COR) and other meetings as required by the protocol, the PI, or the sponsoring agency.
Respond to 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 research support duties that are within the scope of work.
Shall be eligible for enrollment in a Biological Personnel Reliability Program (BPRP)

Qualifications:

Required:

BS (Bachelor of Science) in biology or related field 4+ years' clinical laboratory experience or a clinical laboratory certificate

Preferred:

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).
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.
Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from the start of performance.
Proficient in scheduling and communicating with participants.
Proficient in writing and editing to assist PIs in preparation of their manuscripts, scientific abstracts, and/or research presentations.
Work requires concentration, periods of standing and walking on a regular basis; must work well under pressure, in often changing conditions and research workload.
Ability to exercise independent judgment to determine appropriate action and priorities in the performa