Senior Clinical Research Associate

W2 Contract

Pay Rate: $60 - $63 per hour

Location: Remote Role - PST

Job Summary:

As a Senior Clinical Research Associate (Sr. CRA) Contractor in Clinical Operations, you will be responsible for supporting the Clinical Development Team to ensure the execution of assigned trials according to the study timelines and company goals and in compliance with ICH GCP, country regulations, and SOPs. The primary role involves oversight of 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 the development of 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 in relation to 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 the Clinical Study Lead and assisting with the resolution of 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 vendor selection for some vendors, developing RFI/RFP, collecting feedback, and setting up vendor with guidance.
• Assisting with the review and tracking of vendor scope of work and invoices.
• Generating Purchase Orders.
• Participating in vendor management, including the oversight of 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
• regulations and tracking of site performance metrics.
• Overseeing the implementation of training of Investigator/site staff.
• Assisting in the management of 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 the medical monitor in addressing safety-related questions.
• Ensuring protocol deviations are appropriately classified, documented, and followed up on, in collaboration with the CRO and the medical monitor.
• Supporting Data Management in the escalation of CRF queries to vendors/sites/CRO to ensure the resolution of findings.
• Developing and finalizing the pharmacy manual.
• Supporting IP Accountability activities.
• Collaborating with Regulatory Affairs to ensure the Essential Document Packet is accurate and complete.
• Assisting Quality Assurance with the resolution of site and vendor quality event Corrective Actions and Preventive Actions (CAPA).

Requirements and Qualifications:

• Bachelor's degree with 2-3 years relevant experience, or master's degree with 1 year of relevant experience
• Knowledge of clinical trial processes, medical terminology, and ICH GCP guidelines
• Experience with Trial Master File management according to the DIA reference model
• Experience using eTMF, EDC, IRT, CTMS, and other vendors' systems/portals
• Clear and concise verbal and written communication skills, along with strong organizational skills
• Ability to multitask, 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

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

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.