Cra Ii

Syneos Health · ESP-Remote (Madrid) Syneos Health is seeking a CRA II to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. They will also verify the process of obtaining informed consent, assess factors that might affect subject/patient's safety and clinical data integrity, and apply query resolution techniques. Responsibilities: Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary Utilize available hardware and software to support the effective conduct of the clinical study data review and capture Verify site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation, and reviews storage and security Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents Support subject/patient recruitment, retention, and awareness strategies Enter 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 3-4 years of experience as CRA Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Experience in Immunology, Cardiology, Pulmonary Hypertension, Ophthalmology, or Lipids Excellent communication, presentation, and interpersonal skills