GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed.
Under the general supervision of the Program Manager and Chief of Nuclear Medicine/PET, provides IND monitoring for protocols within the Sponsor's IND portfolio. Working directly with the Program Manager, will help ensure adherence to current FDA regulations, applicable ICH/GCP guidelines, protocol/investigational plans, local policies, and standard operating procedures.
Work directly with the Program Manager to ensure all protocols under the Sponsor's IND portfolio are monitored appropriately.
Ensure the Sponsor, Investigators, and study teams adhere to current FDA regulations, applicable ICH/GCP guidelines, protocol/investigational plans, 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 monitor-related tools and templates.
Monitor clinical trial progress through a combination of data review and on site monitoring visits.
Verify that the trial data is consistent with patient clinical notes and other sources of 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.
Assist in the development and writing of clinical trial monitoring plans.
Provide recommendations and guidance to specific study teams and assist in audit readiness and preparation.
Participate in regular monitoring meetings with the Program Manager.
Assist the Program Manager in writing annual IND reports for the FDA.
All other duties as assigned.
BS or BA or equivalent required. Master's degree or higher preferred.
At least one year of work with increasing responsibility in a clinical research setting preferred.
Ability to work independently and as a team.
Knowledge of ICH guidelines, GCP, and clinical trial study process.
Ability to work effectively in teams as well as independently.
Strong verbal and written communication skills.
Sound independent judgment and competence in clinical research methodologies.
Careful attention to detail.
Brigham And Women's Hospital