As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines.
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 monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
- 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).
- Independently coordinate ongoing and upcoming monitoring assignments
- 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.
- May assist with CRA in-house site related responsibilities
- May participate in Clinical Operations Committees
Required Education & Qualifications:
- Bachelor’s degree in a related health profession or nursing
- 2+ years of oncology monitoring experience required
- Knowledge of FDA regulatory requirements, ICH guidelines, GCP, and commonly used study processes
- Proficient in RDE, CTMS, Excel and MS Word
- Experience with data listing and patient profile review is a plus.
- Ability to work effectively in teams as well as independently
- Strong verbal and written communication skills
- Ability to prioritize and manage multiple tasks and responsibilities
- Excellent communication skills, both oral and written
- May be home or office based depending on location
- National Travel: Approximately 50 – 60%
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.