The CRA assists with the implementation and conduct of clinical studies, focusing on the areas of protocol development, study planning, site monitoring and/or monitoring management, enrollment, data quality and study reporting. The work for this position takes place in an office and not a lab. 1-2 years’ experience as a CRA required.
•May lead small operational study teams, i.e. act as sponsor-CRO liaison or Lead CRA for a particular study.
•Prepares study documents for assigned studies, e.g. consent and assent templates, site reference materials, site monitoring plan, pharmacy manual. Prepares materials for study startup or training, e.g. investigator meetings, vendor kickoff meetings, site initiation visits.
•Responsible for communications relating to assigned studies; generates and distributes meeting agendas, minutes and status reports.
•Manages Trial Master File (TMF) and Clinical Trial Management System (CTMS); responsible for reconciliation of the TMF when transferred from an external vendor.
•Participates in the review of clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory submissions (i.e. IND annual reports, IND and NDA filings) for consistency and quality.
•Participates in the identification and qualification of clinical investigators, and assists with the development of site budgets. May administer site payments.
•Participates in the assessment and selection of vendors and their ongoing performance, i.e. tracking of contracted costs and milestones.
•May conduct site monitoring visits, independently or as a co-monitor, and complete associated visit reports and follow-up documentation. Conducts remote monitoring, via an electronic Case Report Form (eCRF) database.
•Assists with inspection-readiness activities for FDA or other regulatory agency, preparing either internal or external teams (i.e. investigational sites).
•Other duties as assigned.
•Understanding of the study phases and general knowledge of how they apply to drug development.
•Bachelor’s degree in a biological science is preferred.
•Requires a minimum of 1-2 years’ experience as a CRA, with orphan drug/disease and/or pediatric knowledge very helpful.
•Previous experience in pharmaceutical industry required.
•Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary.
•Must be able and willing to travel on a periodic basis.
•Relocation not offered for this position.