Polish CRA based in Switzerland - Basel-Country, Schweiz - Pharmiweb

Beschreibung

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.