FSP Sr. CRA I

Thermo Fisher Scientific • San Diego, CA

9d

About The Position

As a Senior Clinical Research Associate I in the FSP model, you will be dedicated to one specific client and represent that client while collaborating with investigative sites and the project team. You will perform and coordinate clinical monitoring and site management, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. You will help ensure that trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and ensuring reliable data. The role also supports audit readiness and collaborative relationships with investigational sites.

The position involves risk-based site monitoring; evaluating site processes and data; documenting and escalating issues; maintaining contact with sites between visits; supporting site selection, initiation, and closeout; and ensuring essential trial documents and study systems are maintained. You will communicate with sites, the client, and internal teams; contribute to project work and process improvement; and complete administrative tasks. Travel of more than 75% may be required for site monitoring activities.

This is an office-environment role with a standard Monday–Friday schedule. The estimated California salary range is $90,000–$113,000, with possible eligibility for a variable annual bonus based on company, team, and/or individual performance. The company offers a comprehensive U.S. Total Rewards package, including medical, dental, and vision plans; employee assistance and family support programs; paid time off and holidays; parental leave; insurance and disability coverage; retirement savings; and an employee stock purchase plan.

Requirements

• Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent and 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 clinical trial monitoring skills, including remote and on-site monitoring.
• 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 the ability to interact effectively 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.
• Use root cause analysis, critical thinking, and problem-solving to identify site process failures and recommend corrective and preventive actions.
• Review source data, source documents, and case report forms as applicable to ensure data accuracy during remote and on-site monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters promptly, using approved business writing standards.
• Escalate deficiencies and issues to clinical management promptly and follow them through to resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with project team members for resolving issues and findings, and 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 agreed study conventions, and perform quality checks of CTMS reports where required.
• Participate in investigator meetings as necessary.
• Identify potential investigators with the client company and help assess the acceptability of qualified investigative sites.
• Initiate clinical trial sites according to applicable procedures and make recommendations to support protocol, regulatory, and ICH-GCP compliance.
• 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 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, or leading CRA team calls.
• Facilitate communication among investigative sites, the client company, and the project team through written, oral, and electronic contacts.
• 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 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.
• Possible eligibility 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