CRA (Level II)

Job Description

Position Overview

This role involves monitoring investigator sites using a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and reduce risks. The position ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring. Responsibilities include assessing investigational products, documenting observations, escalating deficiencies, maintaining contact with sites, and ensuring study systems are updated. The role also involves identifying potential investigators, initiating clinical trial sites, ensuring essential document completeness, and facilitating communication between sites, clients, and project teams.

Employment Type

Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.
• Monitor investigator sites with a risk-based monitoring approach.
• Apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence and follow-up of previously identified issues.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS).
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements/audits/inspections.
• Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to other project work and initiatives for process improvement, as required.

Requirements

• Bachelor's degree or equivalent experience in a scientific or healthcare-related field.
• Proven experience as a Clinical Research Associate (comparable to 2+ years as a clinical research monitor).
• 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.

Company Information

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.