CRA II - Saudi Arabia
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Key skills for this role
About the Role
Join Thermo Fisher Scientific as a Clinical Research Associate II to perform and coordinate clinical monitoring and site management. You will conduct remote or on-site visits, ensure regulatory compliance, and manage documentation.
Key Skills for This Role
Responsibilities
- Monitor investigator sites with a risk based monitoring approach
- Ensure data accuracy through SDR, SDV and CRF review as applicable
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters in a timely manner
- Escalate observed deficiencies and issues to clinical management
- Maintain regular contact between monitoring visits with investigative sites
- Conduct monitoring tasks in accordance with the approved monitoring plan
- Participate in the investigator payment process
- Initiate clinical trial sites according to relevant procedures
- Perform trial close out and retrieval of trial materials
- Ensure required essential documents are complete and in place
- 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 where applicable
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well developed critical thinking skills
- Good oral and written communication skills
- Ability to maintain customer focus
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
Full Job Posting
Join Us as a Clinical Research Associate (Level II)
- We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
- As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process.
What You’ll Do
- Monitors investigator sites with a risk based monitoring approach: applies root cause analysis, critical thinking and problem solving skills to identify site processes failure and corrective/preventive actions.
- 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 in collaboration with the client company.
Education and Experience Requirements
- 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 years 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, including but not limited to: 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 the utilization of 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
Working Conditions and Environment
- 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 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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