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Clinical Research Associate II / Sr CRA, Serbia - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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Clinical Research Associate II / Sr CRA, Serbia

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  • inVentiv Health - Transforming Promising Ideas into Commercial RealityJob Title:Clinical Research Associate II / Sr CRA, SerbiaPrimary Function:As a Clinical Research Associate you will be at the forefront of the clinical trials practice. As a member of our Clinical Research Team you will reflect its unique characteristics and help world class companies to ensure the right size and custom fit for their trial needs. This is an excellent opportunity enabling you to take your careers and skills to the next level working for the world's largest healthcare clients.Main Responsibilities: * Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 - 50% travel) for GCP compliance according to inVentiv Health SOPs and/or client guidelines * Recruit investigators for participation in clinical trials * Negotiate study budgets with investigators * Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites * Review draft protocols for completeness and feasibility * Develop Case Report Forms for clinical trials * Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators' Meetings * Prepare and process Serious Adverse Event (SAE) reports * Prepare project management reports for clients, project personnel, and inVentiv Health management * Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries * Resolve queries of CRF data with study site personnel * Review Tables and Listings generated from study data * Assist in writing Clinical Study Reports * Train junior CRAs on monitoring, internal procedures, and query resolution * When allocated by study management, submit essential/required documents to a central IRB or a country's central Ethics Committee, and, if necessary based on local requirements, the Competent Authority.Qualifications/Requirements: * Bachelor's Degree or RN * Experience in clinical research, data management, regulatory affairs, or other relevant healthcare research position * Experience in field monitoring of clinical trials * Excellent written and verbal communications skills * Ability and willingness to travel up to 50% * Excellent organizational skills and ability to manage time and work independently.In return we will offer: * Competitive remuneration package with excellent benefits * Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization * Opportunity to work within a successful and rewarding environment.Location: Serbia, home based.We look forward to receiving your application.inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients' therapies to market.


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