POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol, FDA and ICH guidelines.  

                                   

Ideal candidates will be located in the Central US, close to a major airport hub.

 

Essential Job Functions/Responsibilities

  •  Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures.
  • Adhere to clinical trial monitoring plans associated with assigned protocols; (e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates
  • Reviews protocols and associated study lab, safety and data management manuals)
  • Monitor clinical trial progress through a combination of data review and on-site monitoring visits
  • Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review)
  • Ensure ISF/TMF reconciliations are complete and inspection ready
  • Independently coordinate ongoing and upcoming monitoring assignments
  • Serve as the primary site manager between sites and Athenex
  • Meet expected timelines for completion of monitoring activities and submission of written monitoring reports
  • May assist in the development and writing of clinical trial monitoring plans
  • May provide recommendations and guidance to study-specific monitoring teams and assist in audit readiness and preparation
  • Participate in regular monitoring team group meetings
  • Serve as a mentor to other CRA Monitors for their professional development; assists in establishing the priorities of work and leading/coordinator collective work efforts
  • May perform co-monitoring observational assessments as determined by the CRA Manager
  • May perform Lead CRA Monitor activities
  • May be primary point of contact for CRA Monitor support
  • May assist in report review to support studies
  • May assist with CRA in-house/monitor site related responsibilities
  • May participate in Clinical Operations Committees
  • May perform other duties as assigned


Required Education & Experience

  • Bachelor’s degree in a related health profession or nursing
  • Minimum 5 years of clinical study monitoring experience
  • At least 2 years of oncology clinical trial monitoring experience required (both solid tumors and hematological malignancies, highly preferred)
  • 1+ years of cell therapy/gene therapy clinical trial experience, preferred
  • Knowledge of FDA regulatory requirements, ICH guidelines, GCP, and commonly used study processes
  • Experience with data listing and patient profile review is a plus

 

Required Skills & Abilities:

  •  Proficient in RDC, CTMS, MS Excel and MS Word, eTMF
  • Excellent written and oral communications skills with internal and external colleagues
  • Ability to prioritize multiple tasks and responsibilities
  • Ability to work effectively in teams as well as independently
  • Excellent communication skills, both oral and written

 

Working Conditions:

  • May be home or office based depending on location of position
  • Prolonged periods sitting at a desk and working on a computer
  • Must be available for up to 60% national travel.


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.

 

Apply for position now

Are you legally authorized to work in the United States?
Will you now or in the future require sponsorship for employment visa status (e.g. H-1B, O-1, E-3, L-1, or TN)?
How did you hear about this opportunity with Athenex?
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By checking the box below, I attest that all information contained in this application is true and accurate, and I understand that any false statement or omission is grounds for rejecting my application, or for termination of employment if I receive an offer of employment.
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How many years of clinical monitoring experience do you have?
Check off all of the therapeutic areas below that you have clinical trial monitoring experience in: