CRA/Sr CRA - Client decicated (FSP)
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Key skills for this role
About the Role
Thermo Fisher Scientific is seeking a Clinical Research Associate to perform and coordinate clinical monitoring and site management. The role involves conducting remote or on-site visits, ensuring regulatory compliance, and managing 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
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters in a timely manner
- Participate in investigator meetings and initiate clinical trial sites
- Ensure required essential documents are complete and in place
- Provide trial status tracking and progress update reports
- Facilitate effective communication between investigative sites, client and project team
Requirements
- Bachelor's degree in a life sciences related field or Registered Nursing certification
- Previous experience comparable to 1 year as a clinical research monitor
- Valid driver's license
- Proven clinical monitoring skills
- Fluency in Arabic and good English language skills
Full Job Posting
Job Description
- Join Us as a Clinical Research Associate – 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 in the last 5 years.
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
- Participates in investigator meetings as necessary
- Initiates clinical trial sites according to relevant procedures
- Performs trial close out and retrieval of trial materials
- Ensures required essential documents are complete and in place
- Provides trial status tracking and progress update reports to the Clinical Team Manager
- Facilitates effective communication between investigative sites, client company and PPD project team
- Responds to company, client and applicable regulatory requirements/audits/inspections
- Maintains & completes administrative tasks such as expense reports and timesheets
Education and Experience Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent
- 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
- 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
- Fluency in Arabic and good English language and grammar skills
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%
- Exposure to biological fluids with potential exposure to infectious organisms
- Personal protective equipment required
- Exposure to fluctuating and/or extreme temperatures on rare occasions
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