Senior Clinical Research Associate

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.
• Serving as a liaison between the Sponsor and CRO investigative sites, managing vendor activities, and overseeing vendor performance.
• Supporting the conduct, management, and completion of assigned clinical trials under the leadership and guidance of the Clinical Study Lead.
• Participating in study start-up activities, including vendor RFPs and vendor selection, and may lead vendor selection for some vendors.
• Developing and formatting study-related documents/spreadsheets.
• Following study timelines to meet deadlines for assigned tasks.
• Leading oversight of CRO clinical monitoring activities and the overall site management, ensuring compliance with project-specific plans, Good Clinical Practices (GCP), and regulations.
• 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.
• 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.
• Willingness to embrace change and work in a changing environment.
• Proficiency in Microsoft Outlook, Word, PowerPoint, and Excel.

Desired Skills and Experience

• Clinical Trial Management, Clinical Operations, Sponsor-Side Oversight, CRO Oversight, Vendor Management, Investigative Site Management, Clinical Monitoring Oversight, Study Start-Up, Site Feasibility, Site Qualification, Site Selection, Site Initiation, ICH-GCP, Regulatory Compliance, SOP Development, Protocol Review, Study Documentation, TMF/eTMF Management, TMF Quality Control, DIA TMF Reference Model, EDC, IRT, CTMS, Sample Tracking and Reconciliation, Investigational Product Accountability, CRF Query Resolution, Protocol Deviation Management, CAPA, Vendor RFI/RFP and Selection, Scope of Work and Invoice Review, Purchase Orders, Site Budget Negotiation, Site Payment Tracking, Safety Support, Site Training, Performance Metrics, Issue Escalation, Cross-Functional Collaboration, Project Tracking, Microsoft Office