Job Description: Clinical Research Associate

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location Type: Office Environmental Conditions: Office

Position Overview

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects' rights, well-being, and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.

Key Responsibilities

• Site Monitoring: Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to bring the site into compliance and decrease risks.
• Data Accuracy: Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review as applicable through on-site and remote monitoring activities.
• Investigational Product Assessment: Assesses investigational product through physical inventory and records review.
• Documentation & Reporting: Documents observations in reports and letters in a timely manner using approved business writing standards.
• Issue Escalation & Resolution: Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
• Site Communication: May need to maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
• Supervision & Payments: Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
• Team Collaboration: Ensures shared responsibility with other project team members on issues/findings resolution. Investigates and follows up on findings as applicable.
• Investigator Meetings: Participates in investigator meetings as vital.
• Investigator Identification: Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Site Initiation: Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Trial Close-out: Performs trial close-out and retrieval of trial materials.
• Essential Document Management: 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.
• Reporting & Updates: Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• System Updates: Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
• Communication Facilitation: Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
• Regulatory Compliance: Responds to company, client, and applicable regulatory requirements/audits.

Application Instructions

• (No specific application instructions were provided in the original text.)

Company Information

Thermo Fisher Scientific is dedicated to enabling their customers to make the world healthier, cleaner, and safer. They provide resources for individual career goals and advance science through research, development, and delivery of life-changing therapies. Their PPD clinical research portfolio includes clinical trials in over 100 countries and the development of novel frameworks for clinical research, encompassing laboratory, digital, and decentralized clinical trial services.