Clinical Operation Consultant
640 Galveston Drive Redwood City, CA 94063 US
This Clinical Operations Consultant position is a remote role, responsible for the assigned aspects of clinical trial management in support of the clinical development portfolio.
The position will support CRO and vendor management and oversight, including eTMF management. The position will be responsible to execute assigned tasks in accordance with all applicable Standard Operating Procedures (SOPs), with FDA and other applicable regulatory guidance, and with the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP).
- Support Clinical Operations staff to ensure ongoing compliance with clinical protocol and regulatory and ICH GCP obligations in assigned aspects of clinical trial execution
- Assist in management of trial vendors
- Assist with the development and implementation of study-specific plans (e.g., Clinical Monitoring Plan, Project Management Plan, Protocol Deviation Plan, etc.)
- Assist in the review of study documents such as Informed Consents (ICFs)
- Participate in clinical data review
- Responsible for management of electronic Trial Master File (eTMF) for the clinical trial portfolio, including assuring audit readiness at all times throughout the study lifecycle.
- Provide administrative support to Study Execution Team, including preparing agendas, drafting minutes, scheduling, maintaining study trackers, etc.
- Perform miscellaneous job-related duties as assigned.
- Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent
- 3+ year of experience in clinical research trial environment preferred
- General knowledge of regulatory requirements & GCP
- Ability to multi-task and deal with shifting priorities
- Data evaluation skills
- High proficiency with full Microsoft applications
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; highly accurate and detail-oriented
- hourly pay rate of 50-75 per hour
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