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Protocol Development Jobs (NOW HIRING)

Oran Inc

Clinical SME I

Herndon, VA · Remote

Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with clinical, regulatory, and ...

Oran, Inc.

Clinical SME I

Herndon, VA · On-site

Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with clinical, regulatory, and ...

Kite Pharma

OR

$261.38K - $338.25K/yr

... included, developed and empowered to fulfil their aspirations. Join Kite and help create more ... Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports ...

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$53.4K

$81K

How much do protocol development jobs pay per year?

As of Jun 2, 2026, the average yearly pay for protocol development in the United States is $53,418.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,500.00 and $60,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Protocol Development, and why are they important?

To thrive in Protocol Development, you need a solid background in clinical research, regulatory requirements, and scientific writing, often supported by a degree in life sciences or a related field. Familiarity with tools such as clinical trial management systems (CTMS), electronic data capture (EDC), and knowledge of ICH-GCP guidelines is typically required. Strong attention to detail, project management, and effective communication skills help professionals excel in this role. These competencies ensure the creation of clear, compliant, and scientifically sound protocols that are essential for successful clinical trials.

What are the main challenges someone might face when starting in a Protocol Development role?

One of the main challenges in Protocol Development is quickly understanding complex technical standards and aligning them with organizational goals. New team members often need to collaborate closely with cross-functional teams, such as engineering, legal, and product management, to ensure protocols are both technically sound and compliant with industry regulations. Adapting to rapidly evolving technologies and maintaining clear documentation can also be demanding, but strong communication and a willingness to learn can help overcome these hurdles.

What is protocol development?

Protocol development refers to the process of designing and creating detailed plans, often called protocols, which outline the methodology and procedures for conducting research or clinical trials. This includes specifying objectives, study design, data collection methods, and regulatory requirements to ensure the study is scientifically valid and ethically sound. Protocol developers work closely with researchers, regulatory bodies, and stakeholders to ensure all aspects of the protocol meet industry standards and compliance guidelines.

What is the difference between Protocol Development vs Clinical Research Associate?

AspectProtocol DevelopmentClinical Research Associate
Primary RoleDesigns and develops clinical trial protocolsMonitors clinical trials to ensure compliance and data integrity
Required SkillsKnowledge of clinical trial design, regulatory guidelines, and writing skillsMonitoring skills, regulatory knowledge, and communication skills
Work EnvironmentTypically in planning, development, and regulatory teamsOn-site or remote monitoring at clinical trial sites
CertificationsOften requires knowledge of GCP, regulatory affairsGCP certification often preferred

While Protocol Development focuses on creating and designing clinical trial protocols, Clinical Research Associates are responsible for monitoring and ensuring trial compliance at sites. Both roles are essential in clinical research but differ in their core responsibilities and work environments.

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Protocol Development jobs near you
Clinical SME I

Clinical SME I

Oran Inc

Herndon, VA • Remote

Full-time

Posted 11 days ago

Job description

Position Title

Clinical SME I

Overview

We are seeking a Clinical Subject Matter Expert (SME) with extensive experience in clinical trial operations, FDA regulatory processes, and protocol development. The ideal candidate will provide scientific and regulatory expertise supporting clinical research and healthcare initiatives.

Key Responsibilities
  • Review and analyze clinical trial protocols and regulatory documentation.
  • Provide guidance on FDA regulatory requirements and ICH guidelines.
  • Support protocol development, study design, and safety review processes.
  • Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments.
  • Collaborate with clinical, regulatory, and technical teams.
  • Assist in pharmacovigilance and informed consent review activities.
  • Provide subject matter expertise for healthcare and clinical research initiatives.
  • Ensure compliance with applicable federal and clinical research regulations.
Required Qualifications
  • Advanced degree preferred:
    • MD
    • PharmD
    • RN
    • MPH
    • MS in Clinical Research
    • Related clinical/scientific discipline
  • Minimum 10 years of relevant clinical research or regulatory experience.
  • Deep understanding of:
    • Clinical trial protocols
    • FDA regulatory review processes
    • Drug development lifecycle
    • Safety review
    • Protocol design
Required Skills
  • Clinical protocol review
  • ICH guidelines
  • FDA regulatory processes
  • Pharmacovigilance
  • Study design
  • Endpoint analysis
  • Risk-benefit evaluation
  • Informed consent review
Preferred Qualifications
  • RAC (Regulatory Affairs Certification)
  • Active clinical licensure preferred.