Travel-Heavy Clinical Research Associate II

ThermoFisher Scientific; Augusta (ME); Sur place; USD 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

120+ PTO hours

10 paid holidays annually

Parental leave (3 weeks)

Disability coverage

401(k) retirement plan

Résumé du poste

Thermo Fisher Scientific is seeking a CRA (Level II) to lead and coordinate clinical monitoring and site management activities. This role ensures protocol adherence, ICH-GCP compliance, and robust data integrity through on-site and remote monitoring.

The candidate will develop site relationships, manage essential documents, and participate in investigator meetings while traveling extensively to trial sites. A life sciences degree (or RN) and relevant monitoring experience are required.

Qualifications

• Bachelor's degree in a life sciences related field and relevant formal academic qualification.
• 1 year of experience comparable to a clinical research monitor.
• Valid driver's license where applicable.

Responsabilités

• Monitors investigator sites with a risk-based monitoring approach.
• Applies RCA and problem-solving to drive corrective actions and reduce risk.
• Ensures data accuracy through SDR, SDV and CRF reviews during on-site and remote monitoring.
• Assesses investigational products via inventory and records review.
• Documents observations promptly and Escalates issues to clinical management.
• Travels to site locations (travel >60%).

Connaissances

Clinical monitoring

Problem solving

Analytical thinking

English proficiency

MS Office

Formation

Bachelor's degree in life sciences

Registered Nursing certification

Outils

Microsoft Office

Description du poste

Thermo Fisher Scientific is seeking a CRA (Level II) to lead and coordinate clinical monitoring and site management activities. This role ensures protocol adherence, ICH-GCP compliance, and robust data integrity through on-site and remote monitoring.

The candidate will develop site relationships, manage essential documents, and participate in investigator meetings while traveling extensively to trial sites. A life sciences degree (or RN) and relevant monitoring experience are required.