Experience
3 yrs required
Location
Maitland, FL, United States
Posted on
Sep 20, 2020
Profile
Senior Contract Specialist - Medical Research
Duties: Demonstrates, through behavior, core values of Integrity, Compassion, Balance, Excellence, Stewardship, and Teamwork. Orients, trains, and mentors’ new staff as well as contract specialists in areas related to contract drafting and negotiation. In coordination with the Manager Sponsored programs, Clinical Trial Agreements & Contracts manages efforts and workflow to achieve department goals and objectives, such as decreased activation times. Creates, reviews, revises, and negotiates simple and complex research-related contracts, including amendments, consistent with relevant clinical trials study documents (e.g. protocol, informed consent, budget, manuals, etc.), institutional policies and procedures, and applicable federal, state, and local regulations. Exercises independent judgment to provide guidance and interpretation of contract terms, federal, state, and local laws, and institutional policies and procedures internally and externally to resolve issues and to ensure compliance. Follows, develops, and updates established processes pre and post-execution to ensure metrics and tracking, compliance, document harmonization, and timely execution of contracts. Consults with stakeholders and partners to solve simple and complex problems related to research studies and applying knowledge of applicable regulations, institutional policies and procedures, and logistics and programmatic requirements of conducting research. Facilitates the execution of clinical trial agreements and/or related requests. Serves as a liaison with the Institutes, Research Operations and Legal department to ensure clinical trial and other agreements are processed timely. Interacts directly with all levels of management and staff to provide useful information, guidance, and integrity to contract negotiation, execution, and compliance. Assists in developing, enhancing, and communicating policies and procedures in research administration. Manages and/or assists with special projects in research administration processes, as assigned.
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