Clinical Research Associate
Publicerad 2024-06-13
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Join a team that is committed to approaching each opportunity with foresight, character, resilience, and innovation.
Responsibilities:
Assist with the development and negotiation of study budgets for clinical trial centers Assist in the development of clinical protocols amendments, informed consents, CRF source document design, monitoring plan, site instruction manuals, protocol specific training documentation, administrative letters, and other project related documents Serve as liaison between project management team, clinical sites, site investigators, study coordinators, staff members and study CRO Review site data quality trends via trip reports and review data including queries and protocol deviations Assist with the overall management of the project Trial Master File Assist in providing data to support the annual progress reports and the final clinical study report Oversee the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of the investigational Sage products Review source data and case report forms for accuracy, completeness, and integrity of the data, as well as identifying and resolving any data issues Visit report writing and site correspondence Monitoring clinical studies of investigational products. This may include qualification, initiation, interim monitoring, and close out site visits Monitoring studies by reviewing and reporting on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events Qualifications: Minimum 3+ years of direct monitoring and investigative site management experience on the sponsor-side BA/BS degree and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous Sr CRA experience. Excellent organizational skills, strong interpersonal, communications skills and problem-solving skills Flexibility with changing priorities Ability to efficiently perform and prioritize multiple tasks Extensive knowledge of ICH, ISO and FDA regulations Willingness to travel domestically, 50% depending on sites Computer proficiency in Microsoft Word, Excel, and PowerPoint
