Assistant Clinical Research Coordinator

Responsibilities for this Position

Location: USA CA San Diego - 140 Sylvester Rd, Bldg 146 (CAC173)

Full Part/Time: Full time

Job Req: RQ174883

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, Patient Interactions, Protocol Management

Certifications:

Experience:

1 + years of related experience

US Citizenship Required:

Yes

Job Description:

GDIT's Military Health Team is seeking an Assistant Clinical Research Coordinator 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.

HOW YOU WILL MAKE AN IMPACT:

• 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 national emergency or infectious disease outbreaks, the COR will notify the contractor. The COR will also notify the Contracting Officer. The contractor shall provide rapid assessment as they occur and provide appropriate personnel and response task forces with information that can be used to develop effective short and long-term solutions.

• Provide support for protocol-driven scientific research addressing infectious diseases

• Shall be eligible for enrollment in a Biological Personnel Reliability Program (BPRP)

• Recruit and screen subjects using protocol inclusion/exclusion criteria.

• 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.

• Input research data into database.

• Report adverse events to the IRB-protocol PI for submission to governing agencies and sponsors as required by protocol and regulations.

• Evaluate compliance of research subject to protocols and complete documentation of status and progress.

• Conduct telephone or face-to-face interviews and mail government approved 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 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.

WHAT YOU'LL NEED TO SUCCEED:

• Education: BS degree required.

• Required Experience: 1+ years experience in research or clinical research setting

• Preferred Skills: 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.

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

• 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 performance of duties outlined herein.

• US Citizenship Required: US Citizenship required and ability to obtain clearance

WHAT GDIT CAN OFFER YOU:

• Challenging work that makes a real impact on the world around you

• Internal mobility team dedicated to helping you own your career

• 401K with company match

• Diverse, highly collaborative teams

• Professional development, education assistance, certification and training opportunities

#GDITHealth

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The likely hourly rate for this position is between $27.82 - $28.75. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly Hours:

40

Travel Required:

None

Telecommuting Options:

Onsite

Work Location:

USA CA San Diego

Additional Work Locations:

Total Rewards at GDIT:

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation's most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.

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.