Clinical Contract Associate II

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Clinical Contract Associate II. The ideal candidate would be working without appreciable direction, provide technical assistance in negotiating, reviewing, and processing clinical study and research contracts and subcontracts in support of CRMD?s clinical research activities. This position will negotiate with research sites, ensure contracts are written in accordance to associated CRMD and regulatory protocols, obtains necessary approvals from senior management for research sites set-up. Work requires the application of business principles/methods, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year academic course of study. Within a specialized range of expertise, applies clinical principles to the solution of a variety of problems; customarily and regularly exercises judgment in planning, organizing and performing own work; completes special assignments and projects as required. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field(s) of expertise.
Job Duties:
+ Monitors/reviews proposed grants and contracts for compliance with applicable company policy as well as applicable regulations. Performs a variety of activities involved in the review and negotiation of sponsored research grant and contract proposals.
+ In compliance with Company policies and in accordance with applicable regulations as well as the SJM Legal Department, negotiates with research sites. Writes technical contract language covering such issues as indemnification, subject injury language, intellectual property rights, confidentiality, fiscal/procedural constraints, and other similar matters.
+ Assists in obtaining approvals necessary for sponsored grants and contracts, subcontracts, and other agreements; also assists in obtaining grant/contract approvals from senior management; revises budgets as needed, and prepares forms as well as other required information.
+ Maintains up-to-date reference file.
+ Analyzes and resolves technical problems of contract interpretation. Resolves conflicts as necessary.
+ Participates in policy discussions and recommends policy or procedural changes as appropriate; revises and updates procedures as necessary.
+ Prepares periodic comprehensive reports of activities.
+ Remains current on developments in field(s) of expertise, applicable regulatory requirements, and a comprehensive knowledge of the company?s products, markets, and objectives as well as industry trends. Maintains an awareness of, and disseminates information to management and staff on all laws, regulations and nuances that may impact grants & contracts operations by reviewing literature, trade journals, remaining active in professional associations, and by attending conferences/seminars.
+ Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
Required Qualifications:
+ Bachelor?s Degree in Business Administration, a related field, or equivalent
+ Typically a minimum of three to six years of analytical experience or equivalent
+ Familiarity with grant and contract requirements, policies, and procedures including, but not limited to: Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals
+ Knowledge of federal, state and industry rules and regulations governing technical aspects of grants and contracts
+ Requires a demonstrated knowledge of the practices/procedures of the function, company polices, and programs
+ Requires demonstrated written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees
+ Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner
+ Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks
+ Must have demonstrated personal computer skills including a working familiarity with relevant word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel and Access)
+ Some evaluation, originality, and/or ingenuity required
Preferred qualifications:
+ Paralegal certification preferred
+ Previous related experience administering and/or coordinating grant and/ or contract requests in medical device, biologics, or pharmaceutical company
+ Experience preparing and giving presentations
+ Registered nurse, legal, clinical research associate experience desired
+ An advanced degree (i.e., masters and/or doctorate level) as well as professional certifications (i.e., Certified Professional Contracts Manager (CPCM), Certified Clinical Research Professional (CCRP), or related certifications) also a plus
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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