Clinical Research Nurse Jobs in Maryland

Job Overview
Program Management and Technology Services, Inc. (PMTS) is seeking multiple Clinical Research Associates to support the Defense Health Agency (DHA) Research and Development MRDC Office of Regulated Activities (ORA) at Fort Detrick, MD. This is a contingent position pending award of a federal GSA MAS task order with a target start date of August 1, 2026.

The Clinical Research Associate (CRA) supports the conduct and monitoring of FDA-regulated clinical trials across the ORA product portfolio. Working under the direction of the Clinical Trial Manager, CRAs ensure that clinical trials are executed in compliance with the study protocol, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and 21 CFR requirements. This role performs site monitoring visits, source data verification, regulatory documentation review, and quality oversight of clinical trial operations.

Responsibilities

• Conduct pre-study, site initiation, interim monitoring, and closeout visits at clinical trial sites in accordance with the Monitoring Plan and applicable regulations
• Perform source data verification (SDV), source data review (SDR), and query resolution using Electronic Data Capture (EDC) systems including Medidata Rave, Oracle Clinical, and Veeva CDMS
• Review Investigator Site Files (ISFs) and Trial Master Files (TMFs) for regulatory compliance and completeness; ensure essential documents are current and properly maintained
• Verify site compliance with the study protocol, GCP, ICH E6(R2/R3), 21 CFR Parts 11, 50, 54, 56, 312, and applicable ORA standards
• Monitor informed consent processes, subject eligibility, adverse event reporting, and investigational product accountability at study sites
• Prepare monitoring visit reports and follow-up letters within timelines specified in the Monitoring Plan; escalate significant findings to the Clinical Trial Manager and sponsor
• Support Data Safety Monitoring Board (DSMB) preparation and reporting through data reviews, safety data summaries, and query resolution
• Assist with clinical study startup activities including site qualification, regulatory document collection, and IRB submission support
• Contribute to CRF design review, protocol amendment review, and study conduct planning
• Support inspection readiness activities and respond to FDA information requests through data verification and documentation

Required Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field required
• Minimum 4 years of clinical research monitoring experience, including at least 2 years as a lead or independent CRA
• Current knowledge of ICH-GCP, FDA regulations (21 CFR 11, 50, 54, 56, 312, 314, 600), and international regulatory requirements
• Hands-on experience with major EDC platforms (Medidata Rave, Veeva Vault CDMS, Oracle Clinical, Inform)
• Demonstrated experience monitoring Phase I–III interventional clinical trials
• Strong analytical, communication, and documentation skills; ability to interact professionally with site investigators, study coordinators, and Government stakeholders
• U.S. citizenship required; ability to obtain and maintain a T1/HSPD-12 Public Trust investigation
• Ability to travel occasionally to clinical trial sites as required (typical monitoring travel volume: light-to-moderate given DoD-centric portfolio)

Preferred Qualifications

• SoCRA CCRP, ACRP CCRA, or equivalent clinical research certification
• Prior experience supporting DoD, DHA, USAMRDC, BARDA, NIH, or FDA-regulated federal clinical research programs
• Therapeutic-area experience in vaccines, infectious diseases, oncology, or medical countermeasures
• Experience with risk-based monitoring (RBM) and centralized monitoring approaches
• Master's degree in life sciences, public health, or clinical research administration

Pay: $80,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person