Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis and management and in the future will be applied to other conditions beyond cancer.
Under the direction of the Associate Director of Clinical Operations, the Clinical Trial Manager leads the tactical implementation and conduct of clinical research studies. The CTM ensures the quality of each research study through study management and on-site/centralized and remote monitoring of protocol and regulatory compliance. The CTM represents Adela at the research site level and maintains collaborative relationships with investigator sites, contract research organizations (CROs), vendors and the internal clinical development team. The CTM may also be responsible for direct supervision of one or more CRA I/CRA II/CR Assistants.
• Manages and is accountable for all aspects of study conduct. Leads team of assigned CRAs and CROs with regards to study operations.
• Facilitates team meetings with internal cross functional teams on key projects and provides project updates to key stake holders within the organization.
• Lead discussions/interactions with external collaborators.
• Develops operational plans including risk assessments, monitoring plans and communication plans.
• Develops and manages clinical study budgets and contributes to staffing/resourcing plans.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics.
• Participates in trial design and protocol development on a project specific basis.
• 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)
• Manages study start-up activities: o Creates study tools and training materials
o Directs site staff through start-up activities in collaboration with regulatory associate
• 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.)
• Tracks and escalates any safety events • Drafts CAPA/intervention plans
• Tracks enrollment and manages accrual issues
• Reports study metrics to PM and monitors compliance with established timelines
• Maintains trial master files for clinical research projects
• Maintains professional expertise through familiarity with up-to-date medical and clinical operations knowledge • Trains and conducts co-monitoirng visits with junior level CRAs.
•Field site travel up to 25%
• Bachelor Degree: RN/BS/BA; scientific discipline preferred
• Minimum of 5+ years of Clinical Research Associate experience in diagnostics, pharmaceutical, medical device, or CRO setting with substantial experience independently managing a research study
• Knowledge of medical terminology, clinical monitoring procedures (SOPs), and ICH/GCP guidelines
• Excellent oral and written communication skills demonstrated by the ability to present clear instruction/direction and influence at higher levels within the organization; including demonstrated presentation skills
• Ability to lead and gain consensus from cross functional team
• Demonstrated significant problem solving skills
• Excellent organizational, time management and project management skills
• Advanced working knowledge of Excel, Word, PowerPoint, SharePoint