CRA II📣 إعلان

About the Role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA II) to join their team in Riyadh. This full-time position involves coordinating and performing all aspects of clinical monitoring and site management for clinical trials. The role requires a proactive approach to ensuring trial integrity and compliance.

Key Responsibilities

• Monitor investigator sites using a risk-based approach, identifying process failures and implementing corrective actions.
• Ensure data accuracy through source data verification (SDV) and case report form (CRF) review via on-site and remote monitoring.
• Assess investigational products through physical inventory and records review.
• Document observations and deficiencies in reports and letters, escalating issues to clinical management for timely resolution.
• Maintain regular communication with investigative sites to confirm protocol adherence and resolve issues.
• Conduct monitoring tasks in accordance with approved monitoring plans and initiate clinical trial sites according to procedures.
• Perform trial close-out activities and retrieve trial materials.
• Ensure essential documents are complete and compliant with ICH-GCP and applicable regulations.
• Provide trial status updates to the Clinical Team Manager (CTM) and ensure study systems are updated.
• Facilitate communication between sites, the client, and the project team.
• Respond to company, client, and regulatory requirements, audits, and inspections.
• Complete administrative tasks such as expense reports and timesheets.
• Contribute to project team initiatives and process improvement efforts.

Qualifications and Requirements

• Bachelor's degree in a life sciences related field, Registered Nursing certification, or equivalent qualification.
• Previous experience equivalent to approximately 1 year as a clinical research monitor, or completion of a relevant fellowship program.
• A valid driver's license may be required.
• An equivalency of combined education, training, and experience may be considered.

Required Skills and Abilities

• Proven clinical monitoring skills.
• Understanding of medical/therapeutic area knowledge and medical terminology.
• Working knowledge of ICH-GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking, root cause analysis, and problem-solving abilities.
• Ability to manage Risk Based Monitoring concepts.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Customer focus, good listening skills, and attention to detail.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Flexibility and adaptability.
• Ability to work independently or as part of a team.
• Proficiency in Microsoft Office and ability to learn new software.
• Fluency in Arabic and good English language skills.
• Good presentation skills.

Work Environment and Travel

This role involves work in an office, laboratory, clinical, or home office environment. Frequent travel to site locations is required, typically ranging from 60-80%, with potential for extended overnight stays. Exposure to biological fluids may occur, necessitating the use of personal protective equipment. Occasional exposure to fluctuating or extreme temperatures is possible.