Under the direction of the Associate Director of Clinical Operations and the Clinical Trial Manager, the Clinical Research Associate II contributes to the tactical implementation and conduct of clinical research studies. The CRA II ensures the quality of each research study through on-site centralized, and remote monitoring of protocol and regulatory compliance. The CRA II represents Adela at the research site level and maintains collaborative relationships with investigator sites, any potential contract research organizations (CROs), and the internal clinical development team.
Serves as liaison between Adela clinical development team and research site staff with respect to tactical elements of study completion
Assesses site qualification potential (reviews study requirements and identifies sites through feasibility and qualification visits)
Completes study start-up activities:
Assists with creation of study tools and training materials
Directs site staff through start-up activities
Assists with regulatory processes as needed
Conducts on-site initiation, interim monitoring and close-out visits per Adela SOP to ensure data integrity and good clinical practice; writes and submits visit reports
Conducts centralized monitoring tasks (remote data review for identification of queries, data trends, deviations, issue escalation, etc.)
Verifies and fulfills site supply requests for product/study materials
Tracks and escalates any safety events
Drafts CAPA/intervention plans
Communicates site enrollment and study metrics through maintenance of tracking tools
Maintains trial master files for assigned clinical research projects
Maintains professional expertise through familiarity with up-to-date medical and clinical operations knowledge and familiarity with Adela’s product pipeline.
Works independently with minimal instruction and routine supervision by senior level CRA, CTM, or functional manager; may perform as CRA lead on studies as appointed by CRA Manager
Adela’s mission is to develop innovative and accessible technologies that harness biology and change the way we diagnose and treat disease. Adela’s genome-wide methylation enrichment technology was originally developed by Chief Scientific Officer Dr. Daniel De Carvalho, PhD, at University Health Network’s Princess Margaret Cancer Centre. Adela is initially planning to develop the technology for use across the entire cancer continuum—for detection, diagnosis and management of disease.