El Segundo, CA30+ days ago
Communicate scientific rationale for assigned studies to team members and clinical sites • Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements • Create/edit, distribute and collect site feasibility questionnaires • Oversee and support collection of essential documents during study start-up • Collect study and site metrics and maintain study trackers, as needed • Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed • Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits • Partner with field CRAs to resolve issues identified during site visits • Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions • Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues • Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor • Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed • Provide mentorship and training to newly hired research staff. Education & Experience • Bachelors degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting required; or • High school diploma with 8 years of experience in a clinical research setting required • Minimum of 2 years experience as a Clinical Research Associate II or higher required Knowledge, Skills, & Abilities • Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe • Excellent written/oral communication skills as well as strong organizational and multi-tasking skills • Strong organizational and multi-tasking skills • Understand the job-specific system, processes as defined by the companys SOPs, and adhere to the requirements listed in those documents.