CRA/Sr CRA - Client decicated (FSP)

Role Overview

Clinical Research Associate / Senior Clinical Research Associate (Client Dedicated, FSP) at Thermo Fisher Scientific.

Company Overview

Thermo Fisher Scientific has successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Role Purpose

As a Clinical Research Associate (Level II), you will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure trials are 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

Monitoring & Compliance

• Monitor investigator sites using a risk-based monitoring approach.
• Apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site process failures 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 that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Ensure data reliability and audit readiness.

Site Management & Initiation

• 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.
• Develop collaborative relationships with investigational sites.
• Make recommendations for site qualification where warranted.
• Perform trial close out and retrieval of trial materials.

Documentation & Governance

• 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.

Financial & Administrative

• Participate in the investigator payment process.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.

Reporting & Communication

• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.

Regulatory & Quality

• Respond to company, client and applicable regulatory requirements/audits/inspections.
• Ensure the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
• Act as a site processes specialist to ensure data reliability.

Stakeholder & Team Collaboration

• Ensure a shared responsibility with other project team members on issues/findings resolution.
• Investigate and follow-up on findings as applicable.
• Participate in investigator meetings as necessary.
• Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contribute to other project work and initiatives for process improvement, as required.

Qualifications & Experience

• Bachelor's degree in a life sciences related field, or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• In some cases an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient to meet the requirements of the role.

Skills & Competencies

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Fluency in Arabic and good English language and grammar skills.
• Good presentation skills.

Additional Information

Work Schedule

• Standard (Monday–Friday).

Work Environment

• Work is performed in an office, laboratory, clinical and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations.
• Frequent travel, generally 60–80% but more for some individuals.
• May include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.