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Clinical Research Associate II

Clinical Research Associate II
Cranford, NJ, United States Full Time
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POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives.
This position is an office based position. Remote candidates will not be considered for this role.
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 of 3 years in-house oncology experience (Phases 1, 2 and/or 3) in a similar role
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
Proficient in Spanish or Chinese is a plus
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.

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