CRA I/II - FSP - EMEA
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Key skills for this role
About the Role
Thermo Fisher Scientific seeks a Clinical Research Associate (Level I/II) to perform and coordinate clinical monitoring and site management. You will conduct remote or on-site visits, ensure protocol and regulatory compliance, and manage documentation.
Key Skills for This Role
Responsibilities
- Monitors investigator sites with a risk based monitoring approach
- 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 the relevant procedures
- Performs trial close out and retrieval of trial materials
- Ensures that required essential documents are complete and in place, according to ICH GCP and applicable regulations
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
- Facilitates effective communication between investigative sites, the client company and the PPD project team
Requirements
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent
Full Job Posting
Job Description
- Join Us as a Clinical Research Associate (Level I/II) – Make an Impact at the Forefront of Innovation.
- 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 (RCA), 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.
- Participates in investigator meetings as necessary.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
- Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH GCP and applicable regulations.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team.
Education and Experience Requirements
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
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