FSP Sr. CRA I

Thermo Fisher Scientific • San Diego, CA

1d • $90,000 - $113,000

About The Position

As a Senior Clinical Research Associate I in Thermo Fisher Scientific’s FSP model, you will be dedicated to one client and represent that client while collaborating with investigative sites and internal project teams. You will coordinate clinical monitoring and site management, including remote and on-site visits to assess protocol and regulatory compliance, review and maintain required documentation, and help ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs. The role supports subject rights and well-being, reliable data, audit readiness, and productive relationships with investigative sites.

Requirements

• Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 3 or more years.
• Strong critical-thinking and problem-solving skills.
• Excellent remote and on-site clinical trial monitoring skills.
• Demonstrated understanding of ICH-GCP guidelines, applicable regulations, and SOPs.
• Ability to work on problems of diverse scope and evaluate identifiable factors when analyzing data.
• Good judgment in selecting methods and techniques to obtain solutions.
• Strong communication and collaboration skills, including effective interaction with investigative sites, clients, and internal teams.
• Ability to represent the client while maintaining professional relationships.
• Advanced written and oral communication skills.
• Strong organizational skills and attention to detail.
• Demonstrated ability to use computer systems, including CTMS and other trial management platforms.
• Ability to travel more than 75% as required for site monitoring activities.

Nice To Haves

• Oncology experience.

Responsibilities

• Monitor investigator sites using a risk-based monitoring approach.
• Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and develop corrective and preventive actions.
• Ensure data accuracy through source data review, source data verification, and case report form review, as applicable, during on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters promptly and in accordance with approved business writing standards.
• Escalate deficiencies and issues to clinical management and follow them through resolution.
• Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, resolution of previously identified issues, and timely data recording.
• Conduct monitoring tasks according to the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with project team members for resolving issues and findings; investigate and follow up on findings as applicable.
• Provide trial status tracking and progress updates to the Clinical Team Manager as required.
• Update study systems, including the Clinical Trial Management System, according to study conventions, and perform quality checks of CTMS-generated reports when required.
• Participate in investigator meetings as necessary.
• Identify potential investigators with the client company and assess the acceptability of qualified investigative sites.
• Initiate clinical trial sites according to applicable procedures and recommend actions as warranted to support compliance with protocol, regulatory, and ICH-GCP obligations.
• Ensure trial closeout and retrieval of trial materials.
• Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews according to project specifications.
• Assist with preparation of project publications and tools, and share ideas and suggestions with team members.
• Perform additional study tasks assigned by the Clinical Team Manager, such as trip report review, newsletter creation, and leading CRA team calls.
• Facilitate written, oral, and electronic communication among investigative sites, the client company, and the project team.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, in a timely manner.
• Contribute to other project work and process-improvement initiatives as required.

Benefits

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• May be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior