Job Description: Clinical Research Associate (CRA)

Employment Type: Full-time Work Schedule: Standard (Monday-Friday) 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 over 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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start-up to monitoring through to study close-out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

This role is within our FSP (Functional Service Partnership) division, which is a partnership between Thermo Fisher Scientific and one of our strategic clients. In this position, employees will be assigned to work with a specific client to carry out the responsibilities outlined below.

If you are a Nurse, Pharmacist, Site Coordinator, or have other life science/pharma/CRO experience, then please apply now to start your CRA career journey at one of the world’s leading global CROs!

Responsibilities

Discover Impactful Work:

• 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 the sponsor and/or monitoring environments (i.e., FSP client).
• 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.

A Day in the Life:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failures 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 follows all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved, and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Ensures shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows up on findings as applicable.
• Participates in investigator meetings as necessary.
• May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to protocol.

Company Information

Thermo Fisher Scientific is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. Our PPD® clinical research services offer end-to-end support for clinical trials.