Senior Clinical Research Associate

Position: Senior Clinical Research Associate

Location: Newark, CA

Job : 397

# of Openings: 0

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.

• 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.

• 4+ years as a CRA within biotech/pharma, academia, or CRO.

• Bachelor’s Degree, preferably in biological science.

• Yes, up to 25%.

• 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,…