Clinical Research Operations Specialist

2 days ago

Bethesda, Maryland, United States Guidehouse Full time

**About the Role**

A Clinical Research Operations Specialist is needed to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program.

This role is centered around clinical research protocol and informed consent document development, requiring expert writing skills. The specialist will develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, ensuring accuracy, consistency, and completeness of documents.

The specialist will also prepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation. Additionally, they will develop and review completed IND and IDE safety, clinical study reports, and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.

Maintaining all regulatory trial documentation, including a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs, and safety reports, is a crucial aspect of this role. The specialist will assist researchers with protocol development, assembly, and review of clinical trial documents, as well as develop and maintain trial-related documents and operational procedures.

Responsibilities include maintaining study databases, conducting basic analysis, assisting researchers in reviewing and submitting protocol actions for clearance within the NIH Protocol Tracking and Management System, and working with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.

**What You'll Need**

  • A Master's Degree or higher
  • A minimum of TWO (2) years of experience in a clinical trial or clinical research setting
  • Certification in any of the following: Association of Clinical Research Professionals Certified, Professional (ACRP-CP), Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Associate (CCRA)
  • Liaising with regulatory authorities
  • Previous experience in training clinical trial site staff
  • Phases I or II experience and/or regulatory compliance experience
  • Protocol development and protocol navigation knowledge
  • Previous experience with a Clinical Trial Management System (CTMS), Electronic Medical Records System, and/or Electronic Data Capture System

**Salary Range**

$75,800.00-$113,600.00 per annum

**Benefits**

Guidehouse offers a comprehensive total rewards package that includes competitive compensation and a flexible benefits package. This package reflects Guidehouse's commitment to creating a diverse and supportive workplace. Benefits include medical, dental, and vision insurance, personal and family sick time, company-paid holidays, parental leave, 401(k) retirement plan, group term life and travel assistance, voluntary life and AD&D insurance, health savings account, health care & dependent care flexible spending accounts, transit and parking commuter benefits, short-term & long-term disability, tuition reimbursement, personal development, certifications & learning opportunities, employee referral program, corporate-sponsored events & community outreach, and supplemental benefits via Corestream.

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