CRA II - Saudi Arabia
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Key skills for this role
About the Role
Thermo Fisher Scientific is seeking a Clinical Research Associate II in Saudi Arabia to perform clinical monitoring and site management. The role involves conducting remote/on-site visits, ensuring regulatory compliance, and managing documentation.
Key Skills for This Role
Responsibilities
- Monitor investigator sites using risk based monitoring approach; apply root cause analysis and problem solving
- Ensure data accuracy through SDR, SDV and CRF review via on site and remote monitoring
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters in a timely manner
- Escalate deficiencies and issues to clinical management and follow through to resolution
- Participate in investigator meetings and identify potential investigators
- Initiate clinical trial sites according to procedures to ensure compliance
- Perform trial close out and retrieval of trial materials
- Ensure essential documents are complete per ICH GCP and regulations
- Provide trial status tracking and progress update reports to Clinical Team Manager
Requirements
- Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent
- Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship
- Valid driver's license
- Fluency in Arabic and good English language skills
Full Job Posting
Job Description
- Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries.
What You’ll Do
- Monitors investigator sites with a risk based monitoring approach: applies root cause analysis, critical thinking and problem solving skills.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on site and remote monitoring activities.
- Assesses investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures a shared responsibility with other project team members on issues/findings resolution.
- Investigates and follows up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential investigators.
- Initiates clinical trial sites according to relevant procedures.
Education and Experience Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
- Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
Knowledge, Skills and Abilities
- 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
- Good oral and written communication skills
- Ability to maintain customer focus
- 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
Working Conditions and Environment
- Work is performed in an office/ laboratory/clinical/and/or home office environment.
- Frequent drives to site locations. Frequent travel, generally 60 80% but more for some individuals. May also 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.
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