FSP Experienced Clinical Research Associate (CRA II/Sr. CRA I) - Oncology - Respiratory - Cardiovascular - US West

Thermo Fisher Scientific • San Diego, CA

4d

About The Position

Performs and coordinates all aspects of clinical monitoring and site management for oncology, respiratory, and cardiovascular studies. Conducts remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure audit readiness. Applies sponsor-specific procedures and guidelines while ensuring trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and ensuring data reliability. Builds collaborative relationships with investigational sites. The role is an individual contributor with no management responsibility and has a travel requirement of more than 75%.

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 1–5 years as a clinical research monitor depending on level.
• Valid driver’s license where applicable.
• Proven clinical monitoring skills.
• Demonstrated understanding of medical or therapeutic-area knowledge and medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including a critical mindset, in-depth investigation, root cause analysis, and problem-solving.
• Ability to manage risk-based monitoring concepts and processes.
• Good oral and written communication skills, including effective communication with medical personnel.
• Ability to maintain customer focus through listening, attention to detail, and recognition of customers’ underlying issues.
• Good organizational and time-management skills.
• Effective interpersonal skills and attention to detail.
• Flexibility and adaptability across a wide range of scenarios.
• Ability to work independently or as part of a team.
• Good computer skills, including solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.
• Ability to travel frequently; travel is generally 60–80%, and the role specifies a requirement of more than 75%.
• Ability to comply with sponsor, client, and site requirements, which may include disclosure of vaccination status or other personal information.
• Ability to work upright and/or stationary for 6–8 hours per day; perform repetitive hand movements; move frequently; occasionally crouch or stoop and frequently bend or twist the upper body and neck; and lift or carry up to 15–20 pounds.
• Ability to perform under stress, multitask, communicate and understand complex information, and maintain regular and consistent attendance.

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 data review, source data verification, and case report form review, as applicable, during on-site and remote monitoring.
• Assess investigational products 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 and follow them through resolution.
• Maintain contact with investigative sites between monitoring visits as needed to confirm protocol compliance, resolution of issues, and timely data recording.
• Conduct monitoring activities according to the approved monitoring plan and 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.
• 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 make recommendations to support protocol, regulatory, and ICH-GCP compliance.
• Perform trial closeout and retrieve trial materials.
• Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews according to project specifications.
• Provide trial status tracking and progress updates to the Clinical Team Manager as required.
• Update study systems, such as the Clinical Trial Management System, according to agreed study conventions.
• Facilitate communication among investigative sites, the client company, and the project team through written, oral, and electronic contact.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, promptly.
• Assist with project publications and tools, share ideas with team members, and 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.
• Short- and long-term disability in accordance with company policy.
• 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• Variable annual bonus may be available based on company, team, and/or individual performance.

What This Job Offers

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