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Clinical Research Associate
vor 1 Woche
Salary:
Negotiable
Job type:
Interim/Contract
Location:
Pratteln, Switzerland
Function:
Clinical Operations, Clinical Trial Administration
Posted:30/04/2024
Ref:
BBBH2524- Hi I'm
Elliott
, I manage this role
Please note that to be considered for this role you must have the right to work in this location.
***
Key Responsibilities
- For his role you will, review and provide input on trialrelated documents.
- Contribute to the collection and quality control of essential documents.
- Participate in and contribute to trial team meetings.
- Contribute to the CRO/Site selection process.
- Perform accompanied visits, qualification visits, and initiation visits for assigned studies.
- Conduct routine remote and/or onsite monitoring visits and closeout visits.
- Ensure trial compliance with regulatory requirements and ethical standards.
- Manage all trial supplies, including IMP and laboratory supplies.
- Supervise biological samples shipment(s) from the CRO/Site to the bioanalytical laboratory.
- Ensure timely eCRF completion and identify any data discrepancies.
- Responsible for Trial Master File (TMF) and eTMF maintenance and inspection readiness.
- Follow relevant quality control procedures.
Requirements:
- University degree in science or healthrelated discipline and/or degree in Nursing.
- Clinical research experience in a Contract Research Organization (CRO) or Pharmaceutical Company with experience in monitoring onsite clinical trial.
- Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements.
- Understanding of drug development process.
- Good organizational skills including proven ability to manage multiple activities and to set priorities.
- Ability to work independently as well as being a team player.
- Excellent interpersonal skills, able to motivate the site staff and implement the study successfully.
- Strong proficiency in both spoken and written English and Polish communication is essential, with proficiency in additional languages considered advantageous.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
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