Job Title:
Clinical Operations Associate
Location:
521 Cottonwood Dr, Suite 111, Milpitas, CA 95035
Expected hours of work:
Full time, overtime is expected.
Reports to:
Clinical and Regulatory Manager
Department interactions
(what specific positions/department must they communicate with or provide/obtain support from in order to perform essential functions of the job):
CMO
VPs and Directors
Therapeutic Development department
R&D department
QA department
Facility/operational manager
IT
Job Objective (What the position is supposed to accomplish, how it affects other positions and the organization):
Job Objective: The Clinical Operations Associate will manage all operational aspects of assigned clinical program/s.
Responsibilities
- Interact with CRO during identification, RFP and selection process
- Manages the study project plan, including timeline, budget and resources
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, trial master files)
- Contributes to relevant study documentation including clinical protocols, clinical study reports as well as operational plans
- Participates in and facilitates vendor selection process for outsourced activities
- Participates and assists in the coordination of site selections, evaluations and initiations
- Assists in the preparation of training materials and presentations related to the planning and conduct of the trial
- Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP), FDA/ICH regulations and adherence to SOPs.
Qualifications
- Excellent written and verbal skills required.
- Required experience: +3 years R&D experience in academia and/or industry
- Desired experience: Gene and/or Cell Therapy; Clinical Operations and Project Management