CRA II - Saudi Arabia

Role Overview

Clinical Research Associate (Level II) at Thermo Fisher Scientific, located in Saudi Arabia.

Role Purpose

Perform and coordinate all aspects of clinical monitoring and site management across investigational sites. Conduct remote or on-site visits to assess protocol and regulatory compliance, manage 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

Site 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 processes failures.
• Identify corrective and preventive actions to bring sites into compliance and decrease risks.
• Ensure data accuracy through SDR, SDV and CRF review via 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 protocol adherence.
• Confirm that previously identified issues are being resolved and that data is being recorded in a timely manner.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Ensure audit readiness and develop collaborative relationships with investigational sites.

Site Initiation & Closeout

• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory and ICH-GCP obligations.
• Make recommendations where warranted.
• Perform trial closeout and retrieval of trial materials.

Documentation & Essential Files

• 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.

Investigator Payments & Compliance

• Participate in the investigator payment process.
• Ensure shared responsibility with other project team members on issues and findings resolution.
• Investigate and follow-up on findings as applicable.

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 (for example, 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.
• Respond to company, client and applicable regulatory requirements, audits and inspections.

Administrative & Project Support

• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in preparation of project publications and tools.
• Share ideas and 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.
• Equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient in some cases.

Skills & Competencies

• Proven clinical monitoring skills.
• Demonstrated understanding of medical and therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain a working knowledge of ICH-GCP, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including 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 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 to Friday.

Environment & Working Conditions

• 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.