Project Manager * Nuclear Medicine / Per Diem / Day / BWH Radiology

Brigham And Women's Hospital Boston , MA 02298

Posted 10 months ago

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.

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Project Manager * Nuclear Medicine / Per Diem / Day / BWH Radiology

Brigham And Women's Hospital