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CRA I - Sponsor Dedicated | Oncology / Neurology
Syneos Health
Sponsorship not confirmed
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About the job
Syneos Health is seeking a CRA I - Sponsor Dedicated | Oncology / Neurology. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. The CRA I will use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions. Responsibilities: Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits Evaluates overall performance of site and site staff and provides recommendations regarding site-specific actions Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary May perform investigational product (IP) inventory, reconciliation, and reviews storage and security Routinely 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 Supports subject/patient recruitment, retention, and awareness strategies Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Excellent communication, presentation, and interpersonal skills Ability to manage required travel of up to 30% on a regular basis Benefits: Company car or car allowance Health benefits to include Medical, Dental, and Vision Company match 401k Eligibility to earn commissions/bonus based on company and individual performance Flexible paid time off (PTO) and sick time Job Data by YubHub .
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