CRA II

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