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Protocol Development Jobs (NOW HIRING)

Wells Fargo

Senior Specialty Protocol Engineer

Columbus, OH

$100.90K - $138.60K/yr

Core Protocol Development: Architect and build a custom blockchain application using Go , Cosmos SDK , and CometBFT (Tendermint) * Cryptographic Implementation: Implement and optimize privacy ...

Pulmovant

Director, Clinical Development, Pulmovant

$81.90K - $111.60K/yr

Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans and reporting to drive high value clinical data. * Medical strategic oversight and ...

Wells Fargo

Senior Specialty Protocol Engineer

Iselin, NJ

$106.10K - $145.70K/yr

Core Protocol Development: Architect and build a custom blockchain application using Go , Cosmos SDK , and CometBFT (Tendermint) * Cryptographic Implementation: Implement and optimize privacy ...

Wells Fargo

Senior Specialty Protocol Engineer

Concord, CA

$114.70K - $157.50K/yr

Core Protocol Development: Architect and build a custom blockchain application using Go , Cosmos SDK , and CometBFT (Tendermint) * Cryptographic Implementation: Implement and optimize privacy ...

Systimmune

Clinical Development Physician

Princeton, NJ · On-site

$200K - $300K/yr

You will also have the opportunity to participate in the protocol development, clinical development plan, strategic discussion and cross alliance discussion. This will be an associate director or ...

Loyal

Senior Director, Clinical Development

Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for ... Work tightly with: * R&D to vet new drug targets and mechanisms and interpret pre-clinical data

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 ...

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Protocol Development information

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$29K

$53.4K

$81K

How much do protocol development jobs pay per year?

As of Jun 3, 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
Protocol Project Manager

Protocol Project Manager

University of California San Francisco

San Francisco, CA • On-site

Full-time

Posted 4 days ago

Job description

Job Description
The Protocol Project Manager (PPM) will work in the GU Oncology program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and various departments within UCSF providing support. The candidate will be accountable for clinical trial study start up, maintenance, and close out.
A successful applicant will thrive in a fast-paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently.
Duties Include:
  • Complete pre-activation tasks such as feasibility surveys and assessment with study team; lead pre-site selection teleconference calls
  • Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review and Monitoring Committee
  • Serve as Disease Site Committee Administrator, set agendas, and lead meetings in close collaboration with the Site Committee Chair
  • Identify ancillary committee approval with study team required by a protocol and initiate the process for review; complete various applications to ancillary committees such as radiation safety and biosafety applications.
  • Assist PI with the development of concept sheets, protocols, investigational brochure or package insert, and consent forms working in close collaboration with the Protocol Development team for investigator-initiated trials. Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and IRB submission, contract execution, and billing set up; prepare reports and trackers to keep the Disease Site Committee appraised of activation status for all new protocols
  • Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiations
  • Prepare and make submissions to IRB; prepare and maintain regulatory binders
  • Collaborate with ancillary departments to set up operational aspects of new studies (e.g. pharmacy, radiology, and labs)
  • Ensure policies mandated by the UCSF IRB, HDFCCC, federal government, any outside entity, and study team are followed during trial activation pipeline, maintenance phase and close-out.
  • Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit, and monitor visits.
  • Update clinical trial management databases.
  • Assist study team to develop contingency action plans.
  • Lead trainings within the Disease Site Committee and HDFCCC
  • Develop and write group specific SOPs and policies
  • Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.); serve as registration coordinator to help investigators maintain these varied accounts
  • Flexibility to adapt to changing circumstances.
  • Excellent organizational skills, multitasking and communication both written and spoken.

Department Overview:
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of "comprehensive" from the National Cancer Institute (NCI).
The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.
Responsibilities
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
15Yes
Pre-Trial Activation
  • Work with the research program director and PIs to identify potential studies and ensure a diverse research portfolio.
  • Complete pre-activation tasks such as feasibility surveys and assessment with study team; lead pre-site selection teleconference calls
  • Act as the main point of contact between the industry sponsor/collaborator and UCSF.
  • Serve as Disease Site Committee Administrator and coordinate program site committee meeting per NCI and UCSF Protocol Review and Monitoring System (PRMS) standards for meeting conduct and documentation; coordinate protocol reviews and submissions to Disease Site Committee
  • Determine, submit and/or communicate all ancillary committee requirements and approvals.
  • Facilitate the completion of site questionnaires and communication between sponsors/collaborators and PI(s).
  • Assist PI with the development of concept sheets, protocols, investigational brochure or package insert, and consent forms working in close collaboration with the Protocol Development team for investigator initiated trials.
  • Collect and disseminate start up packet documentation from sponsor/collaborator to study team and trial activation teams in the CRSO regulatory unit
  • Submit protocol package to the Protocol Review and Monitoring Committee (PRMC), Committee for Human Research (IRB/CHR) and/or any ancillary committees (i.e. BioSafety, radiation safety, etc.).
  • Track all regulatory approvals and notify study team for trial status and proper training; prepare reports and trackers to keep the Disease Site Committee appraised of activation status for all new protocols
  • Ensure protocol progression through the activation pipeline liaising between the sponsor/collaborator, study team and UCSF trial activation teams (regulatory affairs, budget, and contracts).
  • Request and review trial activation team work for accuracy and completion for ICF drafting, CHR and FDA submission/approval, clinicaltrials.gov registration and NCT#, calendar build, coverage analysis and budget completion including pharmacy, nursing and/or central lab budget, contract execution, COA# and ZZ# from PostAward and billing mechanisms (APEX, HBS).
  • Prepare and make submissions to IRBServe as point of contact for communication with the drug manufacturer as needed, including consent form approval and submission of committee review, approval information and CRSO unit needs.
  • Consult with PI to determine which procedures are standard of care vs. research-related for coverage analysis and radiation safety form completion and submission.
  • Assist PI with responses to protocol review, CHR and ancillary committees, and ensure timely response to stipulations, while proactively tracking and communicating approvals to study team, sponsors/collaborators and trial activation team(s).
  • Provide the CRSO trial activation teams with the necessary documents to begin work such the sponsor's protocol, investigator's brochure or package insert, draft budget, CTA, and ICF template.
  • Review and approve ICF language, MCA with calendar and budget.
    • Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiation teleconference calls
  • Prepare and maintain regulatory binders; ensure that all regulatory documents (committee approvals, 1572, lab certifications, CVs, etc.) are sent and/or obtained from the sponsor/collaborator.
  • Request creation of case report forms for investigator-initiated trials.
  • Collaborate with ancillary departments to set up operational aspects of new studies (e.g. pharmacy, radiology, and labs)
  • Follow up with Nurse Practitioner (NP) and/or CRC to ensure proper communication of required information and documentation (including MD/Infusion Orders, lab information, etc.).
  • Schedule and conduct site initiation visits with PI, CRC, pharmacy, research RN and sponsor.
  • Follow up with investigational pharmacy to ensure correct written orders and drug treatment supply.
  • Interface with affiliates to ensure quick activation or affiliate (e.g., VAMC).
  • For MCT ISTs (UCSF coordinating site), ensure that all participating centers are in compliance and are monitored regularly.
40YesTrial Activation
30
Yes
Study Maintenance
  • Track and manage communication and procedures for all IRB-open studies at various stages, simultaneously; all within compliance standards.
  • Forward all investigator-initiated modification requests to the protocol editors in a timely manner, and send all protocol amendments from industry sponsors to the regulatory affairs specialists, ITR Clinical Trials Budget Office and post-award analysts.
  • Complete and submit updated renewal information for CHR renewals and IND annual reports to the regulatory affairs.
  • Ensure that the electronic clinical trials management database(s) remain(s) current.
  • Assess amendments after notification, process the amendment from protocol review through to budget amendment, and communicate changes to study team members/CRCs.
  • Ensure appropriate correct ICF version is being used by CRCs, and the re-consenting of patients is/is not necessary.
  • Notify industry sponsors/collaborators and study team as timelines change.
  • Maintain up-to-date regulatory binder(s).
  • Interface with Compliance team to ensure that clinicaltrials.gov is updated regularly and appropriately
  • Schedule and lead weekly budget meetings with budget analyst.
  • Prepare for audits and monitoring visits, and corresponding to any outstanding regulatory items.
  • Ensure policies mandated by the UCSF IRB, HDFCCC, federal government, any outside entity, and study team are followed during trial activation pipeline, maintenance phase and close-out.
  • Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit, and monitor visits.
  • Assist study team to develop contingency action plans.
  • Lead trainings within the Disease Site Committee and HDFCCC
  • Develop and write group specific SOPs and policies
  • Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.); serve as registration coordinator to help investigators maintain these varied accounts

5
Yes
Study Close-Out (Including Withdrawal)
  • Ensure data and regulatory repositories are accurately updated, and regulatory paperwork is submitted for close-out, and properly archived; all teams are notified accordingly.
  • Input final results data into clinicaltrial.gov within one year of the study completion date.

10
YesOther Duties as assigned
100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)
Qualifications
Requirements:
  • BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
  • Project management or coordinator experience.
  • Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience.
  • Working knowledge of clinical trial design, clinical study operations, or regulatory approval process.
  • Demonstrated ability to work within a team environment with faculty and staff at all levels.
  • Working knowledge of Microsoft Office applications such as Word, PowerPoint, Project and Excel.
  • Experience working with medical providers and personnel.
  • Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire.

Preferred Qualifications:
  • Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
  • Experience with oncology clinical trials, or related therapies in drug clinical trials.
  • Exposure to, or on the job use of, medical terminology.
  • Experience preparing submissions for IRB, IND safety reporting, or continuing reviews.
  • Experience with clinical trials management software such as OnCore.
  • Licensure for management, healthcare and/or clinical trials coordination (i.e. PMP, CCRP, SoCRA).

About Us
About UCSF
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.
Pride Values
UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.
In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.
Join us to find a rewarding career contributing to improving healthcare worldwide.
Equal Employment Opportunity
The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for ...

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