On-site Clinical Research Associate

Protagonist Therapeutics Inc.; Newark (CA); On-site; USD 125,000 - 135,000; Full time

Job summary

Protagonist Therapeutics Inc. seeks an On-site Clinical Research Associate to support ongoing trials and new studies in Newark, CA. You will lead study setup, site management, and monitoring activities in collaboration with CROs and cross-functional teams.

The role requires a Bachelor's degree, 2+ years of CRA experience in biotech/pharma or CRO, and experience with international Phase 1-2 trials. Strong English communication and a proactive, detail-oriented approach are essential.

Qualifications

• Bachelor’s Degree.
• 2+ years as a CRA within Biotech/Pharma or CRO.
• International Phase 1-2 trial experience preferred.
• Experience in GI, hematology or orphan drugs preferred.
• Strong English communication and attention to detail.

Responsibilities

• Serve as internal primary site operations lead with the Project Manager and CROs.
• Oversee site feasibility, activation and routine monitoring activities.
• Develop and review integrated site plans and weekly progress reports.
• Create contingency plans for site performance and recruitment.
• Ensure trial scope, progress, timelines, and budget adherence.
• Present site management strategy and metrics at meetings.
• Monitor CRO CRA resource utilization and performance.

Skills

CRA experience

Study startup

Site management

GCP awareness

MS Office

Education

Bachelor's Degree

Tools

MS Office

Job description

Position:On-site Clinical Research Associate

Location: Newark, CA

Job Id:416

# of Openings:0

Clinical Research Associate

About Us

Protagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited. ICOTYDE ™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further clinical and regulatory development and commercialization. Protagonist also discovered and led research and development through Phase 3 for MIMRYLO ™ (rusfertide), a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceutical Company Limited for worldwide commercialization. MIMRYLO is approved in the U.S. for the treatment of erythrocytosis in adults with PV. The Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com .

Position Summary

• Support ongoing trials and/or set-up and manage new trials.
• Contributions include:
  • Study planning and start-up,
  • Project, site and vendor management
  • Oversight of study site monitoring and performance
  • Clinical operations input into the general clinical development of Protagonist compounds.

We are committed to a thriving in-office culture. This role requires being on-site at our office in Newark, CA 4 days a week.

Responsibilities

• Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.
• Oversight of the site feasibility activities leading to site selection, activation and routine monitoring activities to ensure ongoing data integrity and quality.
• Develops and reviews integrated site plans/timelines and reports weekly progress including risks and mitigations
• Develops contingency plans for site performance, with regards to recruitment, data quality etc.
• Helps ensure the trial stays within the contracted site management scope, progress, timelines and budget.
• Presents site management strategy and status/metrics at project meetings.
• Monitors and reports on CRO CRA resource utilization, and analyzes expected vs. actual performance
• Implements and leverages best monitoring practices
• Experience and proficiency with Good Clinical Practices (cGCP) and compliance with Protagonist SOPs
• Works closely and effectively with other cross-functional teams to identify best practices and process improvements.
• Proficiency with MS Office computer software
• Other duties and assignments as requested for the overall performance of the function and Company.

Required Skills & Qualifications

• Bachelor’s Degree
• 2+ years as a CRA within Biotech/Pharma or CRO
• Clinical trial experience that includes international Phase 1-2 trials, involving CROs from study set-up through to completion.
• Experience with Gastrointestinal, hematology and/or orphan drug trials preferred.
• High level of appreciation and understanding of the feasibility, regulatory and start-up processes, together along with on-site monitoring and site management.
• Good overall understanding of the major areas within clinical development.
• Excellent communication and interpersonal skills, along with attention to detail and critical thinking skills.
• Strong written and spoken English.
• Ability to collaborate, problem solve and work in a small dynamic organization with minimal supervision, to achieve personal and collective goals.

Pay Range

The base pay range for this position at commencement of employment is expected to be between $125,000 and $135,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

A top priority for Protagonist Therapeutics, Inc. is to provide a robust and comprehensive health and wellness program for our employees and their families. We offer a variety of high-qualitycoverage and benefitoptions.

• Health Care benefits. Protagonist covers 100% of the premium costfor medical, dental, and vision coverage for all full-time employees and their dependents.
• Flexible Spending Accounts – Healthcare FSA, Dependent Care FSA, Commuter Benefits
• 401(k) Plan
• Flexible Vacation Policy
• Life Insurance (Basic, Voluntary & AD&D)