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Clinical Research Specialist - Leading Protocol Development Exp. Req. (Job 1416)

7 hours, 36 minutes ago
United States
Full-time
Senior
Program Manager
Project and Program Management
Statistics
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DLH

DLH

DLH addresses health and national security challenges by providing innovative solutions through digital transformation, research and development, and systems engineering, specifically tailored to enhance the readiness of federal programs.

Construction & Engineering
1K-5K
Founded 1969
View All Jobs 2

Description

  • Lead protocol development, study start-up, and study conduct activities.
  • Develop the protocol document and informed consent forms with input from subject matter experts and investigators.
  • Create and manage study-specific ancillary documents such as manuals of procedure and site training materials.
  • Monitor and communicate study progress and activities to stakeholders.
  • Drive resolution of site issues across all phases of the study.
  • Partner with cross-functional teams including clinical data management, statisticians, and laboratory staff during protocol development and implementation.
  • Develop and implement processes to reduce impediments to protocol development and implementation.
  • Assess current and new processes and implement improvements to increase efficiency across related functional areas.
  • Provide coaching and knowledge transfer to team members.
  • Attend the annual network meeting in the DC area as required.

Requirements

  • Master’s degree in public health, social sciences, or a related discipline strongly preferred.
  • At least 2 years of experience in the design, development, and conduct of Phase I-III clinical trials.
  • Bachelor’s degree accepted with at least 5 years of experience in the design, development, and conduct of Phase I-III clinical trials.
  • Experience leading protocol development, including writing clinical research protocols and ancillary documents, is required.
  • Experience with HIV, hepatitis, and/or tuberculosis trials is preferred.
  • Excellent verbal communication and organizational skills.
  • Ability to follow detailed work instructions.
  • Strong problem-solving and decision-making skills.
  • Ability to handle multiple tasks simultaneously and work collaboratively.

Benefits

  • Basic compensation of $80,000 to $90,000 per year.
  • Additional compensation may include performance incentives and program-specific awards.
  • Personal Time Off (PTO).
  • Medical, dental, and vision insurance.
  • Supplemental life insurance with AD&D, plus short- and long-term disability coverage.
  • Flexible spending accounts.
  • Parental leave.
  • 401(k) retirement plan with a matching component.
  • Training, e-learning resources, certification preparation, and education assistance.

Interested in this position?

Apply directly on the company website

Apply Now

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