POSITION OBJECTIVE:          As Senior Clinical Research Associate, you will work within a clinical team setting to ensure compliance with protocol and overall clinical objectives.  

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

• 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 Clinical Operations team members in the collection, review, and maintenance of regulatory documents; review may include 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)

• Participates in conference calls, prepares agenda and summaries; attends and participates in project and functional area meetings and continuing education; may run Project Team Meetings with oversight from Clinical Project Manager

• May serve as a mentor to other CRAs for their professional development; assists in establishing the priorities of work and leading/coordinating collective work efforts

• May perform other CRA duties as assigned

Required Education & Experience: 

• Bachelor’s degree in life sciences or Nursing

• Minimum 5 years of in-house CRA work experience (oncology preferred, or related field) across Phases 1, 2 and/or 3

• Knowledge of FDA regulatory requirements, ICH guidelines and commonly-used concepts, practices and procedures within Clinical Development 

Required Skills & Abilities:

• Proficient in RDE, CTMS, Excel and MS Word

• Communicates and coordinates effectively, both written and oral communication, with internal and external clients and colleagues

• Ability to prioritize multiple tasks and responsibilities

• Project lead experience preferred

Working Conditions:

• Prolonged periods sitting at a desk and working on a computer.

• May requires regional or national travel to sites or Athenex office locations

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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Do you have a Bachelor's degree in Nursing or a life sciences field?
Do you have experience with oncology clinical trials?