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