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

About the role

We are seeking a Clinical Research Associate (Level II) to join our dynamic team. This role involves performing and coordinating all aspects of the clinical monitoring and site management process, ensuring compliance and data reliability.

Responsibilities

• Makes remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manages procedures and guidelines from different sponsors and/or monitoring environments.
• Ensures audit readiness and develops collaborative relationships with investigational sites.
• Conducts remote or on-site monitoring activities to ensure data accuracy and investigational product assessment.
• Documents observations in reports and letters, escalating observed deficiencies and issues to clinical management.
• Participates in the investigator payment process and ensures compliance with protocols and regulations.
• Facilitates communication between investigative sites, the client company, and the PPD project team.
• Responds to company, client, and regulatory requirements/audits/inspections.
• Completes administrative tasks such as expense reports and timesheets.
• Assists in project publications/tools and shares ideas/suggestions with team members.
• Contributes to process improvement initiatives as required.

Requirements

• Up to 80% travel is expected.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including a drug screening.

Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification and relevant formal academic/vocational qualification.
• Previous experience as a clinical research monitor or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.

Skills

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Knowledge of ICH GCPs, applicable regulations, and procedural documents.
• Ability to apply critical thinking and problem-solving skills.
• Effective communication and interpersonal skills.
• Good organizational and time management skills.
• Good computer skills: solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Benefits

This position is eligible for a comprehensive Total Rewards package, including:

• A choice of national medical and dental plans, and a national vision plan.
• Employee assistance and family support programs.
• Paid time off (PTO), paid holidays, parental leave, accident and life insurance, and short- and long-term disability.
• Retail and savings programs, such as a competitive 401(k) U.S. retirement savings plan and the Employees’ Stock Purchase Plan (ESPP).

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards