• Skip to primary navigation
  • Skip to main content
ASC Therapeutics

ASC Therapeutics

Genes and Cells for Cure

  • About Us
    • Our Team
    • Hemophilia Advisory Board
    • Cell Therapy Advisory Board
    • Join us!
  • Our Technology
  • Focus
    • Gene Therapy
    • Stem Cell Therapy
  • Our Pipeline
  • Our Partners
  • Investors
    • Investors
    • Releases
  • News
    • Publications
    • Industry News
    • Company News

Clinical Operations Associate

February 1, 2021 By admin

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

 

Apply now!

Filed Under: Job Description

Copyright © 2021 ASC Therapeutics

This website uses cookies to improve your experience. We'll assume you accept this policy as long as you are using this websiteAcceptLearn More