Clinical Research Associate I – Sponsor – Dedicated – Ukraine
Job title: Clinical Research Associate I – Sponsor – Dedicated – Ukraine
Company: Syneos Health
Job description: Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You’ll be supported with comprehensive resources based on today’s emerging technologies, data, science and knowledge – instead of practices from the past. Teaming with some of the most talented professionals in the industry, you’ll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
We are currently recruiting for the Clinical Research Associate – Sponsor – Dedicated to be home-based in Ukraine. This is an excellent permanent opportunity where one can develop their skill set further and work on exciting studies of a well-known and established pharmaceutical company.
Your main responsibilities:
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
Reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.The ideal candidate will need the following experience/skills:
Bachelor’s degree or RN in a related field or equivalent combination of education
First experience in the clinical research as a Study Coordinator or CRA will be preferred
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines
Strong organizational skills
Must demonstrate good computer skills
Excellent communication, presentation, interpersonal skills
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Job date: Fri, 14 May 2021 22:31:38 GMT
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