CRA/Sr CRA Client decicated (FSP)📣 إعلان

About the Opportunity

Thermo Fisher Scientific is seeking a full-time Clinical Research Associate (CRA) or Senior CRA, Client Dedicated (FSP), to join our team in Riyadh, Saudi Arabia. This role is integral to a global team that has supported top pharmaceutical companies and biotechs across numerous clinical trials worldwide. We are looking for candidates with 0-1 years of experience in clinical research to contribute to innovation in the field.

Role Overview

As a Clinical Research Associate (Level II), you will perform and coordinate all aspects of the clinical monitoring and site management process. This involves conducting remote or on-site visits to assess protocol and regulatory compliance and managing essential documentation. You will manage procedures and guidelines from various sponsors and monitoring environments, including FSO, FSP, and Government. The role requires acting as a site processes specialist, ensuring trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to safeguard subjects' rights, well-being, and data reliability. You will also be responsible for ensuring audit readiness and fostering collaborative relationships with investigational sites.

Key Responsibilities

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify and resolve site process failures.
• Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring activities.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters promptly, adhering to approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and ensure their resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Collaborate with other project team members on issue/finding resolution and follow up on findings.
• Participate in investigator meetings as required.
• Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures, ensuring compliance with protocol, regulatory, and ICH GCP obligations, and making recommendations as warranted.
• Perform trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place, in accordance with ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems, such as the Clinical Trial Management System, are updated per agreed study conventions.
• 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, and inspections.
• Maintain and complete administrative tasks, including expense reports and timesheets, in a timely manner.
• Contribute to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions.
• Contribute to other project work and initiatives for process improvement as required.

Qualifications and Experience

• A minimum of 0-1 years of experience in clinical research is required for this role.
• Demonstrated understanding of clinical monitoring and site management processes.
• Familiarity with ICH-GCP guidelines, applicable regulations, and SOPs.

Work Environment and Travel

Work is performed in a dynamic environment that may include an office, laboratory, clinical setting, and/or home office, with exposure to electrical office equipment. This role requires frequent drives to site locations and extensive travel, generally 60-80%, which may include extended overnight stays. There is potential exposure to biological fluids and infectious organisms, necessitating the use of personal protective equipment such as protective eyewear, garments, and gloves. Rare exposure to fluctuating and/or extreme temperatures may also occur.

Application Process

Candidates interested in this full-time position are encouraged to apply.