Experienced Clinical Research Associate (CRA II/Sr CRA) - US Central - Multiple Therapeutic Areas Available

Thermo Fisher Scientific • Chicago, IN

19d • $66,800 - $125,000

About The Position

The Clinical Research Associate (Level II) performs and coordinates clinical monitoring and site management activities across clinical trials. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manage documentation, and ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures. The CRA supports audit readiness and builds collaborative relationships with investigational sites while applying sponsor-specific procedures and monitoring environments.

The position uses risk-based monitoring practices to protect participant rights and well-being and ensure reliable trial data. It involves frequent travel to site locations, generally 60–80%, with potential extended overnight stays. Work may take place in office, laboratory, clinical, or home-office environments.

Requirements

• 1–2 years of traveling, on-site monitoring experience.
• Therapeutic experience in at least one of the following areas: oncology, ophthalmology, neurology, cardiology, rare disease, respiratory, obesity, or pulmonary.
• Live within 60 miles of the nearest major airport and be able to travel up to 80%.
• Be legally authorized to work in the United States without sponsorship.
• Be able to pass a comprehensive background check, including drug screening.
• 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 and skills to perform the job, comparable to one year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• Proven clinical monitoring skills and 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.
• Critical-thinking, root-cause-analysis, problem-solving, and risk-based monitoring skills.
• Good oral and written communication skills, including effective communication with medical personnel.
• Customer focus, listening skills, attention to detail, and ability to understand customers’ underlying issues.
• Good organizational, time-management, and interpersonal skills.
• Ability to remain flexible and adaptable and 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 and good presentation skills.

Responsibilities

• Monitor investigator sites using a risk-based monitoring approach, applying 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 during on-site and remote monitoring.
• Assess investigational product through physical inventory and records review, and document observations in reports and letters promptly.
• Escalate deficiencies and issues to clinical management and follow them through resolution; maintain contact with sites between visits as needed.
• Conduct monitoring tasks according to the approved monitoring plan and participate in the investigator payment process.
• Work with project team members to resolve issues and findings and investigate and follow up on findings as applicable.
• Participate in investigator meetings as needed and identify potential investigators with the client company.
• Initiate clinical trial sites according to relevant procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations; make recommendations where warranted.
• Perform trial closeout and retrieval of trial materials.
• Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations, and conduct on-site file reviews as specified.
• Provide trial status tracking and progress updates to the Clinical Team Manager and update study systems according to agreed conventions.
• Facilitate communication between investigative sites, the client company, and the project team.
• Respond to company, client, and regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, in a timely manner.
• Assist with preparation of project publications and tools, share suggestions with team members, and contribute to process-improvement initiatives and other project work.

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 annually and 10 paid holidays.
• Paid parental leave, including three weeks for bonding and eight 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, with eligible colleagues able to purchase company stock at a discount.
• Position may be eligible for a variable annual bonus based on company, team, and/or individual performance.

What This Job Offers

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