CRA II - Saudi Arabia
On-siteRiyadh, Riyadh Region, Saudi Arabia
Job Summary
Monitor investigator sites using a risk-based approach, applying root cause analysis to identify compliance failures and implement corrective actions. Ensure data accuracy through SDR, SDV, and CRF reviews while managing procedures for sponsors and regulatory environments. Assess investigational product via physical inventory and records, then document observations in reports and letters using approved business standards. Escalate deficiencies to clinical management and follow issues through resolution, maintaining regular contact with sites to confirm protocol adherence and data recording. Participate in investigator meetings, initiate clinical trial sites, and conduct on-site file reviews to ensure ICH-GCP compliance. Provide trial status tracking reports and facilitate communication between sites, the client company, and the project team. Respond to audits and inspections, while completing administrative tasks such as expense reports and timesheets.
Required Qualifications
- Bachelor's degree in a life sciences related field
- Registered Nursing certification
- equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor)
- completion of PPD Drug Development Fellowship
- Valid driver's license
- 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
- Ability to manage Risk Based Monitoring concepts and processes
- Fluency in Arabic
- good English language and grammar skills
Desired Qualifications
- Good oral and written communication skills
- ability to communicate effectively with medical personnel
- ability to maintain customer focus through the utilization of good listening skills
- attention to detail
- ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Ability to remain flexibile 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
- ability to learn appropriate software
- Good presentation skills
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