Work Schedule

Environmental Conditions

Job Description

About the Role

Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data
accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence and follow-up of previously identified issues. Conducts monitoring tasks in accordance with the approved monitoring plan.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the
protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).

Responsibilities

• Conduct and monitor clinical trials to ensure strict adherence to protocols and regulatory requirements.
• Implement study protocols and related documents with proven precision.
• Perform site visits to determine compliance and support site staff.
• Collect, review, and analyze clinical trial data to ensure its accuracy and integrity.
• Collaborate with cross-functional teams to successfully implement study plans.
• Prepare and present detailed reports on trial progress and findings.
• Ensure timely and accurate documentation of all clinical activities.

Requirements

• Bachelor's degree or equivalent experience in a scientific or healthcare-related field.
• Proven experience as a Clinical Research Associate.
• Outstanding comprehension of clinical trial processes and regulations.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of an inclusive, collaborative team.
• Excellent communication and organizational abilities.
• Willingness to travel as needed.

What We Offer

At Thermo Fisher Scientific, you will be part of an inclusive and collaborative environment where diverse experiences and perspectives are valued. We offer competitive compensation, opportunities for professional growth, and a chance to create a significant impact on global health.