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Contract TypeContract TypeFull-time
Workplace typeWorkplace typeRemote
LocationLocationRiyadh

About the Role

Thermo Fisher Scientific is seeking a dedicated Clinical Research Associate (CRA) or Senior CRA to join their Functional Service Provider (FSP) team. This role is based in Riyadh, Saudi Arabia, and involves supporting pharmaceutical companies and biotechs in conducting clinical trials. The CRA will be responsible for monitoring and managing clinical trial sites, ensuring adherence to protocols, regulatory guidelines, and maintaining high standards of data reliability. This position contributes to the successful execution of clinical trials while safeguarding the rights and well-being of study participants.

Role Responsibilities

The role involves performing and coordinating all aspects of clinical monitoring and site management. This includes acting as a specialist in site processes to ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs). A proactive approach is required to identify and resolve site deficiencies, fostering collaborative relationships with investigational sites to ensure audit readiness and data integrity.

  • Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis and problem-solving skills to identify and rectify site process failures and implement corrective and preventive actions.
  • Ensure data accuracy through source data review (SDR) and source data verification (SDV), conducting both on-site and remote monitoring activities.
  • Assess investigational product through physical inventory checks and records review.
  • Document observations in reports and letters in a timely manner, adhering to approved business writing standards.
  • Escalate observed deficiencies and issues to clinical management and follow all issues through to resolution.
  • Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence 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 and findings resolution.
  • Participate in investigator meetings as necessary.
  • Identify potential investigators in collaboration with the client company.
  • Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol and regulatory obligations.
  • Perform trial close-out activities and retrieve trial materials.
  • 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.
  • 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, such as the Clinical Trial Management System (CTMS).
  • Facilitate effective communication between investigative sites, the client company, and the project team.
  • Respond to company, client, and applicable regulatory requirements, audits, and inspections.
  • Maintain and complete administrative tasks such as 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 Requirements

  • Bachelor's degree in a life sciences related field, or a Registered Nursing certification, or an equivalent and relevant formal academic/vocational qualification.
  • Previous experience comparable to 1 year as a clinical research monitor, or completion of a PPD Drug Development Fellowship.
  • A valid driver's license where applicable.
  • An equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient.

Required Skills

  • Proven clinical monitoring skills.
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
  • Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents.
  • Well-developed critical thinking skills, including in-depth investigation for root cause analysis and problem-solving abilities.
  • 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.
  • Ability to work in a team or independently as required.
  • Good computer skills, including 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.

Work Environment and Location

This is a full-time, office-based role with a standard Monday-Friday work schedule, located in Riyadh, Saudi Arabia. The position requires frequent drives to site locations and may involve travel of 60-80%, potentially including extended overnight stays. Work is performed in an office environment with exposure to electrical office equipment. There may be occasional exposure to biological fluids and fluctuating temperatures, requiring appropriate personal protective equipment.

Requirements

  • No experience required

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