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Clinical Research Specialist – Leading Protocol Development
DLH CorporationClinical trials specialist leading HIV and infectious-disease protocol development for DLH’s federal health programs. Managing study start-up, conduct, documentation, site issues, and cross-functional clinical research teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial protocols, including development, implementation, and reporting, while effectively collaborating with cross-functional teams. Proficient in creating study-specific documents and enhancing operational efficiency through problem-solving and decision-making.
Highest-signal resume keywords
Protocol DevelopmentClinical Trial ManagementHIV Trials ExperienceVerbal Communication SkillsProblem-Solving Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Research Protocol WritingInformed Consent DevelopmentStudy-Specific Document ManagementPhase I–III Clinical TrialsProcess Improvement
Soft Skills
Organization SkillsCollaborationDecision-Making
Certifications & Qualifications
Master’s Degree in Public HealthBachelor’s Degree in Related Discipline
Industry Keywords
Clinical TrialsAncillary DocumentsStudy Start-UpStudy ConductSite Training Materials
About the role
Key responsibilities & impact- Manage protocol teams as they design, implement, and report results from clinical trials
- Lead protocol development, study start-up, and study conduct activities
- Lead development of protocol documents, incorporating input from subject matter experts and investigators
- Develop informed consent forms
- Develop and manage study-specific ancillary documents, including manuals of procedure and site training materials
- Manage and communicate study progress and activities
- Drive resolution of issues encountered with sites during all study phases
- Partner with clinical data management, statisticians, laboratory, and other cross-functional teams
- Develop and implement processes to mitigate impediments to protocol development and implementation
- Assess processes and implement solutions to improve efficiency
- Provide coaching and knowledge transfer to team members
- Attend an annual network meeting in the DC area
Requirements
What you’ll need- Master’s degree in public health, social sciences, or related discipline strongly preferred, with at least two years of experience in the design, development, and conduct of Phase I–III clinical trials
- Bachelor's degree may be accepted with at least five 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 organization skills
- Ability to follow detailed work instructions
- Strong problem-solving and decision-making skills
- Ability to handle multiple tasks simultaneously and work collaboratively
Benefits
Comp & perks- Basic compensation of $80,000–$90,000 yearly salary
- Performance incentives and program-specific awards may be included
- Personal Time Off (PTO)
- Medical insurance
- Dental insurance
- Vision insurance
- Supplemental life insurance with AD&D
- Short-term disability
- Long-term disability
- Flexible spending accounts
- Parental leave
- Legal services
- 401(k) Retirement Plan with matching component
- Career development training
- Best-in-class e-learning suite for formal and informal learning
- Professional and technical certification preparation
- Education assistance at accredited institutions