Job - Skilled - Recruitment Solutions GmbH
Aufgaben
- Review and provide feedback on trial-related documents and those prepared by CROs, such as protocols, protocol amendments, informed consent forms, power of attorney, case report forms, source document templates, and clinical study reports
- Contribute to the collection and quality control of necessary documents
- Participate in clinical pharmacology team meetings, providing updates on monitoring activities
- Assist in the CRO/site selection process by sharing CRO/site experience if required
- Perform co-monitoring, qualification visits (if required), and initiation visits according to internal arrangements for assigned studies
- Plan and conduct routine monitoring visits remotely and/or on-site, as well as close-out visits, ensuring that CROs/sites deliver high-quality studies, maintain overall study integrity, and comply with the protocol
- Ensure the conduct of assigned studies complies with ICH-GCP guidelines, local regulations, working instructions (WIS), and standard operating procedures (SOPs)
- Identify CRO/site issues, ensure their resolution, and/or escalate problems as necessary
- Report any observations during on-site and remote monitoring visits to the clinical pharmacology team and CRO/site staff by completing contact reports, monitoring visit reports, and follow-up letters according to applicable procedures
- Site compliance with regulatory requirements and ethical standards throughout the study
- Proper enrollment and understanding of study requirements
- Act as the central communication link between the clinical pharmacology team and CRO/site staff from IRB/IEC approval to the close-out visit for assigned studies
- Manage all study supplies, including IMP and lab materials, from receipt to return or destruction as needed
- Oversee the shipment of biological samples from CRO/sites to the bioanalytical or central lab as appropriate
- Ensure timely completion of eCRF, if applicable, and actively identify any data discrepancies by remotely reviewing eCRF data in collaboration with the data scientist
- Ensure query resolution is completed in a timely manner and oversee database lock in collaboration with the clinical pharmacologist and data scientist
- Responsible for maintaining and inspection readiness of the Trial Master File (TMF) and eTMF
- Ensure the creation and maintenance of the Investigator Site File
- Adhere to relevant quality control procedures to verify that quality requirements for study activities are met
- The role requires presence in Basel with 50-60% travel, predominantly to sites in Poland
Qualifikationen
- Proficient in English AND Polish
- Degree in a scientific or healthcare-related field and/or a nursing diploma
- 1-3 years of experience in clinical research within a CRO or pharmaceutical company with on-site clinical monitoring experience
- High familiarity with ICH-GCP guidelines and other applicable regulatory requirements
- Understanding of the drug development process, with knowledge supporting dermatological compounds in phase 1 and 2 being advantageous
- Good organizational skills, including proven ability to manage multiple activities and prioritize effectively
- Ability to work independently
About the company