Senior Clinical Research Associate

Senior Clinical Research Associate

Job Summary

The Sr. CRA is responsible for the execution of key clinical trial activities as delegated by the Clinical Trial lead. Key responsibilities focus on the logistical support for a trial which includes monitoring and management of clinical sites, vendor management and data review, query generation activities on single center or global studies.

Skills & Attributes

Clinical trial experience that includes international Phase 1-3 trials, involving CROs or IST trial led by Investigators, 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

4+ years as a CRA within Biotech/Pharma, Academia or CRO

Education Required

Bachelor's Degree, preferably in biological science.

Travel Required

Yes, up to 25%

Core Responsibilities

Overall Study Execution

• Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to:
• Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •
• May assist with development and coordination of any trial-specific sub-studies •
• Assist with selection, set-up and management of select vendors and clinical sites •
• Ensure activities under CRA''s responsibility are in compliance with GCP/ICH and all local regulatory guidelines
• Identify areas and methods to improve study processes and systems Site Management / Monitoring
• Lead or participate in site monitoring activities, with oversight by CTM, including:
• Evaluation and selection of new investigators
• Draft and/or review study monitoring documents such as monitoring plan, trip report template, monitoring tools, etc.
• Prepare sites for study initiation, including contract/budget finalization, collection/review of regulatory document and review/development of any training materials; conduct site initiation visits, in coordination with CRO
• May conduct interim site monitoring visits according to study monitoring plan and SOPs (including source document verification, eligibility review, AE/SAE review, study drug accountability, regulatory binder review); may conduct co-monitoring visits for studies outsourced to CROs. Activities may include but not limited to:
• Ensure proper documentation of informed consent
• Ensure proper reporting of adverse events and appropriate follow-up
• Perform source document verification of completed CRFs for completeness and accuracy of data
• Review of investigator regulatory document binder/files
• Work closely with assigned study sites to identify and resolve site-specific issues
• Ensure routine communication with study sites and that sites are adequately informed of necessary study information
• Review monitoring quality metrics and CRO monitoring reports; identify risks and communicate issues to CPM for resolution
• Provide written reports and follow-up letters summarizing site visits, site communication and study-related discussions
• Assist with planning and coordination of study Investigator''s Meetings and other external study meetings (DMC/DSMB, steering committee, etc.) Vendor Management
• Support study vendor management by performing key activities as delegated by study CTM, including but not limited to:
• Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors • Manage the day to day interactions with select study vendor(s), such as a central or specialty lab including developing training materials, lab manuals and acting as first point of contact for issue and query escalation and resolution
• Review vendor invoices and track against contract and study budget to anticipate and address any deviations Data Management/ Biostatistics
• May support study Data review by performing key activities as delegated by Study CTM Drug Supply/ Sample Management
• May support drug supply management, inventory and accountability for assigned clinical sites (determining site readiness for shipment, coordinating tracking of inventory/shipments with designated Clinical Supply Manager)
• May assist the reconciliation of biomarker samples with Personalized medicine from assigned sites (or all sites) Financial • Review and submit invoices for CTM, CPM and Finance approval for sites/vendors under CRA''s responsibility
• 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 $135K and $150K / 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 https://www.protagonist-inc.com.