Provides materials for protocol development to study chairs and assistance in implementing protocol development policies and procedures.
Formats, proofreads, and edits protocols. Distributes protocol drafts for review, integrates technical and scientific information from multiple sources, and incorporates necessary revisions.
Ensures protocol compliance with the Alliance model protocol and current policies and procedures, and federal regulatory requirements and guidelines.
Sets schedule for each protocol under development and ensures that all members of the study team (study chair, committee chair, statistician and data coordinator) adhere to timeline as closely as possible. Works closely with Executive Officers and study teams to identify and resolve impediments to the development process.
Acts as liaison to funding agencies (NCI CTEP and/or DCP) staff, the Cancer Trials Support Unit (CTSU), and the NCI Central Institutional Review Board (CIRB) regarding studies in development or undergoing revision, and monitors progress of review performed by these organizations.
Identifies and seeks resolution of issues raised during the course of review.
In collaboration with study team, prepares response to review, makes all necessary revisions to the protocol document, and submits all necessary materials.
In conjunction with the Executive Officer, ensures that protocols meet pharmaceutical sponsor requirements. Drafts or assists in drafting of model patient consent form, ensuring compliance with federal guidelines and templates for informed consent documents.
Prepares amendments for active protocols as required. Obtains necessary approvals, including submission to the Alliance Data and Safety Monitoring Board, the CIRB, and CTEP. Prepares and distributes amendments to the group membership via the Alliance website.
Identifies emergent issues arising during development and implementation of studies and seeks resolution of such issues. Implements emergency procedures as required.
Fields telephone queries from clinical research associates, nurses and physicians at Alliance institutions regarding conduct of studies. Responsible for addressing administrative issues and referring scientific/medical inquiries to the appropriate individuals as needed.
Coordinates events, research logistics, assists with planning and preparing presentations, event outreach, and post-event write ups.
Assists with other administrative projects as needed and acquire higher level guidance and skills.
Performs other related work as needed.
Some clinical research experience strongly desired.
Knowledge of program subject matter (health care, medicine, clinical research).
Strong analytical and problem- solving skills.
Attention to detail.
Strong organizational skills.
Strong oral and written skills.
Strong interpersonal and customer service skills.
Ability to work independently and as part of a team.
Ability to work on multiple projects simultaneously, set priorities and meet deadlines.
Cover Letter (preferred)
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