Position:
On-site Clinical Research Associate
Location:
Newark, CAJob Id:
416
# of Openings:
0
Clinical Research AssociateAbout UsProtagonist 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 .Position SummarySupport ongoing trials and/or set-up and manage new trials.Contributions include:
Study planning and start-up,Project, site and vendor managementOversight of study site monitoring and performanceClinical 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.ResponsibilitiesServes 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 mitigationsDevelops 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 performanceImplements and leverages best monitoring practicesExperience and proficiency with Good Clinical Practices (cGCP) and compliance with Protagonist SOPsWorks closely and effectively with other cross-functional teams to identify best practices and process improvements.Proficiency with MS Office computer softwareOther duties and assignments as requested for the overall performance of the function and Company.Required Skills & QualificationsBachelor’s Degree2+ years as a CRA within Biotech/Pharma or CROClinical 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.BenefitsA 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-quality coverage and benefit options.Health Care benefits. Protagonist covers 100% of the premium cost for medical, dental, and vision coverage for all full-time employees and their dependents.Flexible Spending Accounts – Healthcare FSA, Dependent Care FSA, Commuter Benefits401(k) PlanFlexible Vacation PolicyLife Insurance (Basic, Voluntary & AD&D)Short Term & Long Term DisabilityCompany paid lunch and snacks
Apply for this Position
On-site Clinical Research Associate
Location:
Newark, CAJob Id:
416
# of Openings:
0
Clinical Research AssociateAbout UsProtagonist 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 .Position SummarySupport ongoing trials and/or set-up and manage new trials.Contributions include:
Study planning and start-up,Project, site and vendor managementOversight of study site monitoring and performanceClinical 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.ResponsibilitiesServes 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 mitigationsDevelops 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 performanceImplements and leverages best monitoring practicesExperience and proficiency with Good Clinical Practices (cGCP) and compliance with Protagonist SOPsWorks closely and effectively with other cross-functional teams to identify best practices and process improvements.Proficiency with MS Office computer softwareOther duties and assignments as requested for the overall performance of the function and Company.Required Skills & QualificationsBachelor’s Degree2+ years as a CRA within Biotech/Pharma or CROClinical 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.BenefitsA 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-quality coverage and benefit options.Health Care benefits. Protagonist covers 100% of the premium cost for medical, dental, and vision coverage for all full-time employees and their dependents.Flexible Spending Accounts – Healthcare FSA, Dependent Care FSA, Commuter Benefits401(k) PlanFlexible Vacation PolicyLife Insurance (Basic, Voluntary & AD&D)Short Term & Long Term DisabilityCompany paid lunch and snacks
Apply for this Position
On-site Clinical Research Associate in newark at Unknown Company
This position is listed as contract and onsite.