Clinical Research Associate in Slovakia

Exiting new opportunity! We are currently seeking a CRA in Slovakia to work at Accelsiors, a well-established international CRO, we work with some of the most interesting and challenging indications and provides clients with the professional support they need throughout the drug development process.

Purpose of Job:
The Clinical Research Associate is the primary responsible for managing the investigative site, from site identification and selection, through site activation, subject enrolment and study conduct until close out, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and any applicable regulations and Accelsiors and/or sponsors’ SOPs.

Job Components:
Non project specific duties: Completes all role specific trainings and records these trainings; Regularly meets with the line manager, and escalates any issues regarding work load or need of additional training.

Communication to third parties: Adheres to the communication plan stated in the Project Plan; Acts as and Accelsiors representative as required when contacting or meeting with local regulatory authorities; Is the primary contact for the study site/s; Participates in company, study and site audits, and may act as one of the contacts for the auditor if required; If approved by the Clinical Team Lead (CTL), may contact local/global vendors as required for the management of their sites.

Project set-up: Supports with site selection process by contacting the candidate sites to send or collect back the Confidentiality Disclosure Agreement (CDA), briefing package and feasibility questionnaire (FQ); Upon approval of a candidate site, arranges and performs Site Selection Visit; Within one week of the site selection visit, or sooner if otherwise indicated by the Clinical Team Lead (CTL) and/or sponsor, completes and provides a site visit report to the CTL and a follow up letter for the site. Revises and corrects the site visit report as indicated by the CTL to ensure the report is final within 14 days of the visit, etc.

Project conduct: Provides regular status reports to the CTL; Attends regular CRA meetings and internal project team meetings as required; Attends client meetings as requested; Performs regular site monitoring visits; Within a maximum of 5 working days the visit to the site, completes the visit report detailing all relevant information collected on site, and submits it to the CTL for review and finalization within another week, during which the CRA corrects or completes any missing information as required by the CTL; Within a maximum of 5 working days after the visit to the site, writes and sends to the site the follow up letter summarizing the findings and the actions to be completed.

Project closure: Ensures data management has locked the subject at the site, i.e. that all data has been source data verified as indicated in the clinical management plan, and there are no data or queries pending to be resolved; Ensures final accountability, inventory and reconciliation of the IMP is performed and documented, and that any reminding IMP is returned or sent for destruction previously agreed; Ensure study records are stored as per GCP-ICH, local regulations requirements and/or any other study specific requirements, etc.

Management of the timelines and quality of deliverables: Adheres to Scope of Work as described in Project Plan and Clinical Management Plan and procedures to ensure compliance with agreed timelines for study deliverables and milestones; Follows the study specific instructions and processes defined by the sponsor and/or project team at each time point; CRAII/CRAIII: May lead a group of CRAs from their region or different regions to coordinate some study activities, reporting to the CTL.

In case of interest, do not hesitate to send us your Curriculum Vitae in English language to the email: [email protected]