20 Commerce Drive, Suite 100 Cranford, NJ
Job Category: Clinical: Clinical Operations and Development
Job Number: 2052
As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines.
- 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
- Bachelor’ s degree in a related health profession or nursing
- 2+ years of oncology monitoring experience
- 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%