POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives.
This position is based in our Buffalo, New York office.
Essential Job Functions/Responsibilities
- Participates in the preparation and/or review of draft protocol and informed consent documents
- Possesses detailed knowledge of the study protocol and its associated activities and timelines
- Participates in conference calls, prepares agenda and summaries
- Coordinates with project team and other study personnel to determine data collection requirements based on protocol and to test electronic case report forms
- May review and contribute to, and processes project documents and required reports, such as study protocol documents and consent forms, SAE and protocol deviation reports, accrual and other study status and/or study site reports
- Contributes to project-specific site initiation activities, tracks readiness status of sites for study initiation, (e.g., submission of essential documents, writes and distributes corresponding internal reports)
- May conduct site assessments, including site activation, interim monitoring and close-out visits. Writes and distributes site visit reports within established timelines, and tracks resolution of outstanding issues
- Supports Senior Monitors in the collection, review and maintenance of regulatory documents.
- Review includes assessment of completeness and compliance with regulatory requirements
- Prepares and reviews study and project materials, (e.g., Standard Operating Procedures (SOPs), Safety, Monitoring and Issue Escalation Plans, Laboratory Manuals, Data Management User's Guides, and Study Tools
- Reviews data listings for inconstant or missing data
- Generates queries, produces and distributes exception reports and resolves data discrepancies
- Coordinates with the project statistician or CRO to develop and produce project-specific reports
- Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs
- Maintains documentation required by corporate and project SOPs
- Prepares and may conduct training sessions for site personnel on GCP, study protocol requirements, data systems and data management practices
- May participate in internal audits and other project and corporate quality assurance activities
- Reviews and contributes to project-required reports (e.g., MS Project Gantt and Timeline reports)
- Attends and participates in project and functional area meetings and continuing education
- Communicates and coordinates effectively with internal and external clients and colleagues
- May be assigned to special assignments as determined by the Department Head and/or Supervisor
Required Education & Qualifications
- Bachelor’s degree in life sciences or Nursing
- Minimum 6+ years’ in-house oncology experience, phases 1, 2 and/or 3; must also have field experience.
- Knowledge of FDA regulatory requirements, ICH guidelines and commonly-used concepts, practices and procedures within Clinical Development
- Proficient in RDE, CTMS, Excel and MS Word
- Excellent communication skills, both oral and written
- Ability to prioritize multiple tasks and responsibilities
- Must be available for up to 20% to 30% national travel
- Proficient in Spanish or Chinese is a plus