Job Description

Senior CRA / Clinical Research Associate

W2 Contract

Salary Range: $89,400 - $104,000 per year

Location: South San Francisco, CA - Hybrid Role

Job Summary:

As a Senior Clinical Research Associate, you will support the Clinical Development Team in ensuring the execution of assigned trials according to the study timelines and company goals and in compliance with ICH GCP, country regulations, and SOPs. You will oversee CRO investigative site management activities from the Sponsor perspective (i.e., in-house Sr. CRA responsibilities) and vendor management. This role provides the opportunity to expand one's knowledge and experience in clinical research and management of clinical trials.

Duties and Responsibilities:

• Contributing to developing the Clinical Operations SOPs, best practices, work instructions, tools, and templates.
• Reviewing protocol/amendment for operational aspects, discrepancies, and quality.
• Preparing/updating, and participating in the review of study documents concerning the study protocol/amendment.
• Supporting the conduct, management, and completion of assigned clinical trials under the leadership and guidance of the Clinical Study Lead.
• Partnering with team members and other functional areas, including Regulatory Affairs, Clinical Pharmacology, Clinical Development, Quality Assurance, Legal, Data Management, and Biostatistics, to perform study-related activities.
• Providing accurate and up-to-date information, including study status reports, to the study team members.
• Timely issue escalation to Clinical Study Lead and assisting with resolving issues.
• Sample tracking and reconciliation.
• Coordinating delegated study management activities and tracking
• Development and formatting of study-related documents/spreadsheets.
• Following study timelines to meet deadlines for assigned tasks.
• Participating in study start-up activities, including vendor RFPs and vendor selection, and may lead to vendor selection for some vendors, develops RFI/RFP, collects feedback, and sets up the vendor with guidance.
• Assist with review and tracking of vendor scope of work and invoices.
• Generating Purchase Orders.
• Participating in vendor management, including overseeing vendor performance, communicating expectations, and tracking performance metrics
• Preparing vendor oversight plans and responsible for the oversight of some vendors.
• Cultivating and maintaining excellent working relationships with study vendors.
• Leading oversight of CRO clinical monitoring activities and the overall site management, ensuring compliance with project-specific plans, Good Clinical Practices (GCP), and applicable regulations, and tracking of site performance metrics.
• Overseeing the implementation of training for Investigator/site staff.
• Assisting in managing the ongoing filing of study documents to the TMF, including performing periodic QC of assigned sections of the TMF and providing TMF support & guidance for CTA. Reviewing CRO TMF Plan.
• Participating in study start-up activities, including feasibility, site qualification, site selection, and site initiation.
• Negotiating site budgets (as applicable).
• Overseeing the status of site payments planned vs. actual.
• Supporting medical monitor by addressing safety-related questions.
• Ensuring protocol deviations are appropriately classified, documented, and followed up on in collaboration with CRO and medical monitor.
• Reviewing the Safety Management Plan
• Supporting Data Management in escalation of CRF queries to vendors/sites/CRO to ensure resolution of findings.
• Developing and finalizing pharmacy manual.
• Supporting IP Accountability activities.
• Collaborating with Regulatory Affairs to ensure the Essential Document Packet is accurate and complete.
• Assisting Quality Assurance with resolving site and vendor quality events, Corrective Actions, and Preventive Actions (CAPA).
• Assisting in planning and organizing Investigator Meetings, including developing and reviewing investigator meeting material and possibly presenting at investigator meetings.

Requirements and Qualifications:

• Bachelor's degree with 3-7 years of relevant experience
• Knowledge of clinical trial processes, medical terminology, and ICH GCP guidelines
• Start-up phase experience
• Vendor Management Experience
• Experience with Trial Master File management according to the DIA reference model
• Experience using eTMF, EDC, IRT, CTMS, and other vendor systems/portals
• Clear and concise verbal and written communication skills, along with strong organizational skills
• Ability to multi-task, prioritize, track projects, and follow through on time with assigned tasks
• Exceptional attention to detail
• Ability to work independently and as part of a team
• Proactive; applies critical thinking to improve execution of study tasks
• Ability to learn quickly and effectively using newly acquired skills
• Willingness to embrace change and work in a changing environment
• Ability to work collaboratively across cultures and geographies
• Proficiency in Microsoft Outlook, Word, PowerPoint, and Excel

Desired Skills and Experience

Clinical Development, Vendor management, Sample management experience, laboratory, Trial Master File, eTMF, EDC, IRT, CTMS, Microsoft Office

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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