CRA / Clinical Research Associate

Location
Basel, Switzerland
Salary
£46.17 - £57.08 per hour
Posted
04 Jul 2019
Closes
01 Aug 2019
Ref
mc 24638
Contact
Mark Cussens
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
An excellent opportunity has arisen to join a leading pharmaceutical company as a CRA.

Job Responsibilities

* Contribute to the collection and the quality control of essential documents required for the Investigational Medicinal Product (IMP) shipment approval
* Participate in and contribute to the Clinical Pharmacology study team meetings by providing updates on monitoring activities
* Contribute to the CR0/Site selection process by sharing any experience with a CR0/Site (when required)
* Perform qualification visits (when required) and initiation visits as agreed with the Clinical Pharmacologist for the assigned studies
* Schedule and conduct routine monitoring visits and close-out visits at the frequency determined for the assigned studies, assuring that the CROs/Sites are delivering high quality research, overall integrity of study implementation, and adherence to the protocol at the clinical sites
* Ensure that the conduct of the assigned studies complies with ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs)
* Identify CR0/Site issues, ensure resolution, and/or escalate issues if necessary
* Report to the Clinical Pharmacology study team and the CR0/Site staff any findings noted during monitoring visits by completing monitoring visit reports and follow-up letters as per Idorsia processes
* Manage the assigned CR0/Site(s) through regular contacts to ensure about:
o Site compliance with regulatory requirements and ethical standards throughout the study,
o Adequate enrolment, and
o Understanding of study requirements
* Operate as a central communication link between the Clinical Pharmacology study team and the CR0/Site staff from the time of the IRB/IEC approval to the close-out visit, for the assigned studies
* Manage all study supplies, including (but not limited to) IMP and laboratory supplies, from receipt to return or destruction, as appropriate
* Supervise biological samples shipment(s) from the CR0/Site to the bioanalytical laboratory or central laboratory (when appropriate)
* Ensure timely eCRF completion, if applicable, and proactively identify any data discrepancies by remotely reviewing the eCRF data
* Ensure that query resolution is completed in a timely manner and supervise database lock in collaboration with the Clinical Pharmacologist and the Data Scientist
* Responsible for Trial Master File (TMF) maintenance
* Ensure set-up and maintenance of the Investigator Site File
* Ensure about the transmittal of requested TMF documents under the CRA's responsibility (e.g., Delegation of Authority) to Idorsia
* Ensure completion of Clinical Trial Management System when applicable

Candidate's Requirements

* University degree in science or health-related discipline and/or degree in Nursing
* Minimum 1-2 years clinical research experience in a Contract Research Organization (CRC) or Pharmaceutical Company with experience in monitoring on-site clinical trials
* Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements
* Understanding of drug development process

Additional experience requirement of the Senior Clinical Research Associate
* Minimum 4-5 years clinical research experience in a CR0 or Pharmaceutical Company with experience in monitoring on-site clinical trials including 2+ years' experience in monitoring early phase clinical trials (i.e., phase 0, 1, 2a), phase 1 experience advantageous


Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.

Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: mcussens@keypeople.co.uk
Tel: +41 4350 86620 or email: mark.cussens@keypeopleswitzerland.ch

Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years.
-We achieve results faster
-Our candidates really are a cut above
-We add greater value
We think it's because we're a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.





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