Clinical Operations Support Associate
Round Lake, IL
Req ID 51460BR
Business Title
Clinical Operations Support Associate
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
The Clinical Operations Support Associate will be responsible for working with the Manager, Contracts and Budgets to ensure that all contracts pertaining to clinical research are brought to execution in a timely, compliant and cost effective manner in support of Clinical Development and Operations (CD&O) clinical study timelines and goals. The primary responsibility will be to assist the Manager, Contracts & Budget in preparing clinical contracts for Medical Products, CD&O department. This position will review, negotiate, and ensure appropriate approval and final sign-off of all Medical Products, CD&O agreements. The position's responsibilities will include interacting with the Corporate Legal department, Finance and Baxter's Ethics and Compliance Department's Healthcare Fraud and Abuse Control Program (HDAC), to ensure that each agreement adheres to and enforces policies and applicable ethical, regulatory and clinical standards. Additional responsibilities will be tracking of payments to vendors, organizations, consultants and contractors in order to remain compliant with Sarbanes Oxley guidelines.
Contract management for clinical trials, this includes but is not limited to:
•Develop and maintain contract templates to ensure compliance with FDA guidelines (as well as Ex-US Regulatory Guidelines.
•Interface with Legal for contract revisions during contract negotiation.
•Provide legal and budgetary support for Investigators and Clinical Research Organizations.
•Amendments and addendums as needed.
•Assist in the review, finalization, approval, and final sign-off of the Clinical Agreements. Interact with Corporate Legal Personnel, PSM (Purchasing and Supplier Management), HFAC, Finance to ensure all agreements are compliant with Baxter's internal processes and Guidelines.
•Assist in the preparation of all CD&O contracts, consultant contracts with major key opinion leaders (KOLs)
•Records Management
•Tracking of payments to organizations, vendors, consultants and contractors in order to remain compliant with Sarbanes Oxley
•Tracking of grant payments
•Tracking Financial Disclosure to be compliant with FDA requirements.
•Administration Functions
Job Requirements
•Excellent interpersonal skills
•Strong oral and written communication skills
•Ability to organize, prioritize, exercise necessary follow-through skills, and work independently
•Handle numerous, diversified duties simultaneously under significant time pressures
•Technically competent with various computer software (Word, Excel, Powerpoint, Visio, Documentum, Access, Ariba/Baxter Buy-Right
•BS/BA and a minimum 2-3 years experience working in a pharmaceutical environment.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
