FSP Sr CRA I

Thermo Fisher Scientific • Denver, CO

4d • $90,000 - $113,000

About The Position

As a Senior Clinical Research Associate I in the FSP model, you will be dedicated to one specific client and act as its representative while using strong communication and collaboration skills. You will perform and coordinate clinical monitoring and site management, conducting remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will serve as a site processes specialist, ensuring trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to protect subjects’ rights and well-being and ensure data reliability. You will also maintain audit readiness and develop collaborative relationships with investigational sites.

The position involves risk-based site monitoring, identifying and resolving site process issues, reviewing clinical data and investigational products, maintaining study documentation and systems, and communicating trial status and findings to the project team. It also supports site selection, initiation, and closeout; investigator meetings and payments; audits and inspections; and project initiatives. Travel of more than 75% may be required for site monitoring activities.

The role requires a bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification, and comparable experience of 3+ years. Oncology experience is preferred. The salary range estimated for this position based in Colorado is $90,000–$113,000, with potential eligibility for a variable annual bonus. The schedule is standard Monday through Friday, and the environmental condition is listed as office.

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+ years.
• Strong critical-thinking and problem-solving skills.
• Excellent clinical trial monitoring skills, both remote and on-site.
• Demonstrated understanding of ICH-GCP guidelines, applicable regulations, and SOPs.
• Ability to address problems of diverse scope that require evaluation of identifiable factors through data analysis.
• 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 use of 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 corrective or preventive actions.
• Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) 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 using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management promptly and follow them through resolution.
• Maintain regular 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 other project team members for resolving issues and findings; investigate and follow up on findings as applicable.
• Provide trial status tracking and progress reports to the Clinical Team Manager (CTM) as required.
• Update study systems, including the Clinical Trial Management System (CTMS), according to agreed study conventions; perform quality-control checks of CTMS-generated reports where 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 relevant procedures and ensure compliance with the protocol, regulations, and ICH-GCP obligations; make recommendations where warranted.
• 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 as specified by the project.
• Assist with project publications and tools and share ideas and suggestions with team members.
• Perform additional study tasks as assigned by the CTM, such as trip report review, newsletter creation, or leading CRA team calls.
• Facilitate effective 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, promptly.
• 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 (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• Potential 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