Clinical Research Associate (CRA)

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Location Type: [Not Specified] Salary: [Not Specified] 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.

As a CRA, you will perform and coordinate different aspects of the clinical monitoring and site management process, including audit readiness. Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation, procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). You will play a key role in 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.

Key Responsibilities

• 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 corrective/preventive actions to bring the site into compliance and decrease risks.
• 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.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Brings 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 the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Performs trial close-out and retrieval of trial materials.
• 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.
• Provides trial status tracking and progress update reports to the team as required.
• Ensures study systems are complete, accurate, and updated per agreed study conventions (e.g., Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company, and internal project teams through written, oral, and/or electronic contacts.
• Responds to company, client, and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.

Qualifications

• Bachelor's degree in a life science field.