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**Req ID:** RQ201473

**Type of Requisition:** Regular

**Clearance Level Must Be Able to Obtain:** None

**Public Trust/Other Required:** NACLC (T3)

**Job Family:** Medical Affairs

Skills:

Clinical Research,Data Compilation,Research Protocols

Experience:

4 + years of related experience

US Citizenship Required:

Yes

Job Description:

GDIT's Military Health team is hiring a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.

The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.

This is a hybrid position and will report onsite 1-2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.

The CRA shall provide clinical trial monitoring to ensure clinical trials are conducted and deliverables provided according to 21 CFR 312, International Conference on Harmonization (ICH) practices, other applicable regulations, policies, and ORA SOPs. The monitor will:

HOW YOU WILL MAKE AN IMPACT:

Develop, implement, and maintain clinical monitoring plans.

Perform onsite and/or remote clinical monitoring activities inside and outside the continental United States for site qualification, site initiation, interim, and close-out visits.

Qualify sites for conducting clinical trials, which includes developing criteria, conducting the visit, documenting the findings, and making recommendations on whether a proposed clinical site and principal investigator (PI) meet the requirements for executing of the proposed clinical trial

Prepare or review calibration and maintenance records to ensure equipment is adequate, current, and accessible.

Review and help maintain clinical site regulatory files, also referred to as the regulatory binder or site file.

Prepare and perform site initiation training

Review electronic and/or paper source documents for completion, accuracy, and consistency

Perform source data verification (SDV) to ensure the quality and accuracy of data recorded and in a timely manner to allow major study milestones to occur on schedule.

Generate and resolve queries to address any findings, issues, and/or inconsistencies in a timely manner to allow major study milestones to occur on schedule.

Review other site documents, information, and materials applicable to the study Review shipment procedures and records, which includes shipping documentation for products, biological samples, and other study supplies.

Prepare and/or review laboratory sample and product accountability reports

Prepare and/or review sample accountability and product accountability logs

Identify and mitigate, or assist in mitigating, safety and data quality risks, to include implementing, reviewing, and managing corrective and preventative actions (CAPAs)

Submit documents to be filed in the sponsor’s regulatory file.

Follow-up on monitoring visit findings until resolution. Work to resolve findings in a timely manner to allow major study milestones to occur on schedule.

Coordinate and prepare for monitoring visits for single and multi-site studies.

Prepare clinical monitoring reports that document all clinical monitoring activities and findings.

Provide feedback on monitoring reports prepared by other clinical monitors.

Provide verbal and written input and subject matter expertise to ORA and external study teams.

WHAT YOU’LL NEED TO SUCCEED:

Bachelors degree, 4+ years’ experience supporting clinical research

Experience developing, implementing, and maintaining clinical monitoring plans

Experience performing onsite and/or remote clinical monitoring activities (travel when necessary)

Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), preparing Clinical Monitoring Reports and file in the sponsor’s regulatory file.

Experience providing remote evaluation of the study data

Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file.

Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites.

Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.

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

\#militaryhealth

\#GDITLabScienceJobs

\#GDITFedHealthJobs

The likely salary range for this position is $72,509 - $86,250. 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.

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 50 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.

Join our Talent Community to stay up to date on our career opportunities and events at https://gdit.com/tc.

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans