CRA II/Sr CRA - Ophthalmology

Syneos Health is seeking a CRA II/Sr CRA - Ophthalmology. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities and close-out visits. They will verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient. The CRA II/Sr CRA will assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.

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
• 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
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% 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