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Oncology Protocol Development

I am responsible for the development of phase I and II oncology clinical trials (drug, device, imaging, data collection, tissue collection, etc.) at an academic medical center. Approximately 50 hours/week.


My duties include:


- meeting with investigators who are interested in writing trials (or who have trials in progress)
- meeting with management about trials in progress (so that the people who are in charge of budgeting and research coordinators know how to plan)
- writing trials based on concepts provided by investigators
- drafting consent forms and other documents required to initiate a study
- completing applications for internal scientific and ethical review committees
- corresponding with these committees
- corresponding with pharmaceutical companies about trials in progress (if they’re providing financial support or drug support)
- corresponding with external groups (such as FDA, RAC, etc.)
- creating research databases so that research coordinators will have places to collect data for the trial

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