Polish CRA based in Switzerland - 1 FTE - 12 month contract
Location | Switzerland |
Discipline: | Clinical Operations |
Job type: | Contract |
Salary: | £CHF 56.77 - CHF 65.25 |
Contact name: | Harry Henson |
Contact email: | harry.henson@rbwconsulting.com |
Contact phone: | +44 (0)1293 364 092 |
Job ref: | PLCRACHF2 |
Published: | 4 months ago |
Duration: | 12 month contract |
Expiry date: | 01 Aug 2024 10:59 |
Startdate: | ASAP |
RBW Consulting are currently partnered with a Swiss based, industry leading, Biotech in their search for a Freelance CRA who is fluent in both Polish and English, to join their 6 strong team on a 1 FTE, 12 month contract.
The studies you will be working on will be within Dermatology, with a keen focus on Psoriasis, so previous monitoring experience in these areas would be desired. Estimated travel time / time on site is around 40-50%.
RESPONSIBILITIES AND TASKS
Review and provide input on requested trial-related documents and on any CRO prepared documents, e.g., protocol and protocol amendment, Informed Consent Form, Delegation of Authority, Case Report Forms Study-Specific Monitoring Plan (SSMP), trial forms, source document templates, Clinical Study Report
Contribute to the collection and the quality control of essential documents
Participate in and contribute to the Clinical Pharmacology trial team meetings by providing updates on monitoring activities
Contribute to the CRO/Site selection process by sharing any experience with a CRO/Site (when required)
Perform accompanied visits, qualification visits (when required) and initiation visits as internally agreed for the assigned studies
Schedule and conduct routine remote and/or on-site 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
Ensure that the conduct of the assigned trials complies with ICH-GCP Guidelines, local regulations, working instructions (WIS) and Standard Operating Procedures (SOPs)
Identify CRO/Site issues, ensure resolution, and/or escalate issues if necessary
Report to the Clinical Pharmacology trial team and the CRO/Site staff any findings noted during onsite and remote monitoring visits by completing contact reports, monitoring visit reports and follow-up letters as per processes
Manage the assigned CRO/Site(s) through regular contacts to ensure about:
Site compliance with regulatory requirements and ethical standards throughout the trial
Adequate enrolment and understanding of trial requirements
Operate as a central communication link between the Clinical Pharmacology trial team and the CRO/Site staff from the time of the IRB/IEC approval to the close-out visit, for the assigned trials
Manage all trial 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 CRO/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 in collaboration with the Data Scientist
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) and eTMF maintenance and inspection readiness
Ensure set-up and maintenance of the Investigator Site File
Follow relevant quality control procedures to verify that the quality requirements for the trial related activities are fulfilled
If allocated, act as a Project Manager for trials assessed as having a low level of complexity (e.g., Drug-Drug Interaction studies) as defined by the Head Clinical Pharmacology
If allocated, create, review, update, and provide input to CP and cross-functional QS documents, to ensure compliance with Regulations, and company policies and procedures
Please apply here and Harry Henson will be in touch to discuss your application further.
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