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.