Job Description
Clinical Research Associate
Job 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.
Skills & Attributes
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.
Experience Required 2+ years as a CRA within Biotech/Pharma or CRO
Education Required Bachelors Degree
Travel Required Yes, up to 10%
Core 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.
The base pay range for this position at commencement of employment is expected to be between $125K and $135K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc.,a Johnson & Johnson company. 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 development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.
More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at .
Job Tags
Full time, Worldwide