Senior CRA II – Sponsor Dedicated, Cell & Gene Therapy

Role Overview

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documents
• Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures
• Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages
• Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities
• Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise
• Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders
• Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases
• Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
• Collaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialists

Requirements

• Bachelor's degree in a related field
• Minimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA I
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong scientific background
• Strong experience in Cell & Gene Therapy
• Certified Clinical Research Associate (CCRA) or equivalent certification preferred
• Proficiency in clinical trial management systems and software
• Ability to manage multiple projects and priorities
• Strong attention to detail and organizational skills
• Ability to travel as required for on-site monitoring
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Tech Stack

• Google Cloud Platform

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time