Senior Clinical Research Associate

Position: Senior Clinical Research Associate Location: Newark, CA Job Id: 397 # of Openings: 0 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 logistical support for a trial which includes monitoring and management of clinical sites, vendor management, and data review, as well as query generation activities on single-center or global studies. Skills & Attributes Clinical trial experience with international Phase 1-3 trials, involving CROs or investigator-led studies, from study set‑up through completion. Experience with gastrointestinal, hematology, and/or orphan drug trials preferred. High level of appreciation for feasibility, regulatory and start-up processes, including on‑site monitoring and site management. Good overall understanding of major areas within clinical development. Excellent communication and interpersonal skills, attention to detail, and critical thinking skills. Strong written and spoken English. Ability to collaborate, problem‑solve, and work independently in a small dynamic organization. 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: Lead key activities delegated by the Clinical Study lead, including development and review of study operational documents (study reference manual, laboratory and pharmacy manuals, data management plan, monitoring plan, etc.). 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 compliance with GCP/ICH and local regulatory guidelines. Identify areas and methods to improve study processes and systems. Site Management / Monitoring: Lead or participate in site monitoring activities under CTM oversight, including evaluation and selection of new investigators. Draft and review study monitoring documents (monitoring plan, trip report template, monitoring tools, etc.). Prepare sites for study initiation, including contract and budget finalization, regulatory document review, and training material development; conduct site initiation visits in coordination with CRO. Conduct interim site monitoring visits according to study monitoring plan and SOPs (source document verification, eligibility review, AE/SAE review, study drug accountability, regulatory binder review). Ensure proper documentation of informed consent and adverse event reporting. Perform source document verification of completed CRFs. Review investigator regulatory binder and resolve site‑specific issues. Maintain routine communication with sites and ensure timely information flow. Review monitoring quality metrics and CRO reports; identify risks and communicate to CPM. Provide written reports and follow‑up letters summarizing site visits. Assist with planning and coordination of study investigator meetings and other external meetings (DMC/DSMB, steering committee). Vendor Management: Support vendor management by evaluating new vendors, drafting and reviewing RFPs, analyzing responses, and drafting work orders. Manage day‑to‑day interactions with selected vendors, including training material development and issue escalation. Review vendor invoices and track against contract and study budget. Data Management / Biostatistics: Support data review by performing key activities as delegated by Study CTM. Drug Supply / Sample Management: Support drug supply management, inventory, and accountability for assigned sites. Reconcile biomarker samples with personalized medicine data from assigned or all sites. Financial: Review and submit invoices for CTM, CPM, and finance approval for sites/vendors under CRA responsibility. Oversight of site feasibility activities leading to site selection, activation, and routine monitoring for data integrity and quality. Develop integrated site plans, timelines, and weekly progress reports including risks and mitigations. Develop contingency plans for site performance relating to recruitment, data quality, etc. Ensure the trial stays within contracted scope, progress, timelines, and budget. Present site management strategy and status/metrics at project meetings. Monitor and report on CRO CRA resource utilization and performance. Implement and leverage best monitoring practices. Demonstrate proficiency with Good Clinical Practices (cGCP) and Protagonist SOPs. Work closely with cross‑functional teams to identify best practices and process improvements. Proficiency with MS Office. Perform other duties and assignments as requested to support overall function and company objectives. The base pay range for this position at the commencement of employment is expected to be between $135,000 and $150,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. #J-18808-Ljbffr