Clinical Research Associate (CRA) - Prague, Czech Republic Nr ref.: /JOBS.pl Role: Clinical Research Associate (CRA) Location: Prague - Office Based Job Type: Permanent About Pharm-Olam International: With offices among the world's most populated cities, Pharm-Olam International provides cost effective coverage for full service or strategic outsourcing across all therapeutic areas and phases of research. Since 1994 we have used our local knowledge of an investigator's past performance, competing studies, and regulatory environment to offer sponsors an accurate and informed plan to complete trials on time. For more information about careers at Pharm-Olam please visit our careers page: Summary: To ensure that Investigators are conducting clinical trials in accordance with international regulatory and ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH). May be responsible for assisting the RA department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications. Key Responsibilities: Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and POI SOPs for monitoring requirements. Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Collects and reviews regulatory documents as required. Prepares site visit reports and telephone contact reports. May participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings. Resolves site issues, including site recruitment challenges, and determines status for IP shipment. Works with Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA), regulatory team members or sponsor to secure authorization of regulatory documents and site contracts. Informs team members of completion of regulatory and contractual documents for individual sites. Attends Investigator Meetings (IM) and study specific training meetings. May translate, coordinate translations or review completed translations of critical documents. Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed. Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required. Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings. Provides secondary in-house review of CRFs/eCRFs (if required). Works both independently and in a team environment. Desired Skills and Experience: A minimum of 2 years experience in a similar role Fluent English & Czech, both written and verbal Strong therapeutic background Can demonstrate experience and knowledge in the CRO industry that will support Pharm-Olam's management of clinical trials Demonstrates the ability to define and meet project requirements. Proven organizational abilities, and excellent written and oral communication and presentation skills An understanding of regulatory submissions and reporting requirements and guidelines Excellent understanding of the drug development process. **Please note that you must be eligible to live and work in The Czech Republic in order to apply for this position** Keywords: CRA, CRA I, CRA II, CRA III, Senior CRA, Clinical Research Associate, In-House CRA, Permanent CRA, Contract CRA, Freelance CRA, CRO, Clinical Research Organisation, Risk Based Monitoring, Late Phase, Early Phase, CTL, Clinical Team Leader, Project Manager, Junior Project Manager, EC Submissions, Clinical Research Manager, CRA Manager Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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