Sr. Clinical Research Associate

Thermo Fisher Scientific

Full-time - Mid Level

Remote

Computer and Electronic Product Manufacturing

About the position

The Sr. Clinical Research Associate is responsible for monitoring investigator sites using a risk-based approach, ensuring compliance with protocols and regulations, and maintaining data accuracy through various monitoring activities. This role involves conducting on-site and remote monitoring, documenting observations, and collaborating with project teams to resolve issues and improve processes. The position requires strong analytical skills and the ability to mentor junior team members while participating in investigator meetings and site initiation processes.

Responsibilities

• Monitor investigator sites with a risk-based approach.
• Apply root cause analysis and critical thinking to identify site process failures.
• Ensure data accuracy through SDR, SDV, and CRF review during monitoring activities.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters using approved business writing standards.
• Escalate observed deficiencies to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites between monitoring visits.
• Conduct monitoring tasks according to the approved monitoring plan.
• Participate in the investigator payment process.
• Provide updates on potential trends across multiple sites to the Clinical Team Manager.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company.
• Initiate clinical trial sites to ensure compliance with protocols and regulations.
• Ensure trial closeout and retrieval of trial materials.
• Conduct on-site file reviews as per project specifications.
• Mentor new team members and assist in project publications/tools preparation.
• Identify areas for potential process improvements and share solutions.

Requirements

• Bachelor's degree in Biology, Science, Chemistry or related field.
• Three years of experience as a Clinical Research Associate II, Clinical Research Associate I, Remote Site Monitor, or related role.
• Experience with clinical monitoring and FDA guidelines.
• Knowledge of ICH GCPs and applicable regulations.
• Familiarity with risk-based monitoring concepts and processes.
• Experience using clinical systems such as EDC and CTMS.
• Proficiency in root cause analysis and corrective and preventative action planning.
• Experience in monitoring visit reporting and site management.