Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
Demonstrates diligence in protecting the confidentiality of each subject/patient
Assesses factors that might affect subject/patient’s safety and clinical data integrity
Requirements
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
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis
Benefits
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite initiationinterim monitoringsite managementprotocol complianceinformed consentclinical data integrity
Soft skills
judgmentexperiencerecommendationsdiligencecommunicationpresentationinterpersonalability to manage travel