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Location:

Toledo Hospital

Department:

Enterprise System Research

Weekly Hours:

40

Status:

Full time

Shift:

Days (United States of America)

Job Summary:

ACCOUNTABILITIES

*All duties listed below are essential unless noted otherwise*

+ Evaluates contract terms to ensure compliance with ProMedica policies, applicable governmental regulations, and legal requirements in coordination with ProMedica legal counsel.

+ Verifies that all agreements include required language that supports the interests of ProMedica.

+ Serves as the primary liaison between sponsors and ProMedica Legal to ensure timely review, feedback and resolution of contract matters from initiation to contract execution.

+ Consults with ProMedica Legal and/or Compliance on disputed issues and/or language to resolve contract issues with any funded research study.

+ Assists in reviewing budgets for consistency with contract terms and institutional cost principles.

+ Drafts appropriate amendments and/or sub-contracts, as needed, and ensures signatures obtained by all parties.

+ Develops and maintains a centralized tracking system for all clinical research contracts, providing regular metrics and status updates on negotiations and contract progress.

+ Stays up to date on contemporary compliance research activities. Monitors executed contracts so ensure current regulation and compliance standards are met.

+ Establishes and maintains effective relationships with pharmaceutical, biotechnology, and medical device sponsors, contract research organizations and higher learning institutions.

+ Other duties as assigned to contribute to compliance throughout the lifespace of the contract including study start-up activities through closure.

REQUIRED QUALIFICATIONS

**Education** : Bachelor’s Degree in Legal Studies or Bachelor’s or Associate’s Degree in Paralegal Studies. Relevant experience may be considered in lieu of formal degree.

**Skills** : Must have proven ability to draft and review contracts. Must possess knowledge of relevant contract law and practices common to contracting. Knowledge of research practices helpful.

**Years of Experience** : 2 years

**License** : As appropriate to education and field.

**Certification** : N/A

PREFERRED QUALIFICATIONS

**Education** : N/A

**Skills** : Knowledge of ProMedica standard practices and policies helpful, but an understanding of federal and state regulations relating to clinical trials contracting (e.g. subject injury and indemnification, intellectual property, publication rights, HIPAA, and access to records) or similar regulatory experience is recommended.

**Years of Experience** : 3 years

**License** : N/A

**Certification** : N/A

WORKING CONDITIONS

**Personal Protective Equipment:** N/A

**Physical Demands:** Must be able to move about facility and travel between ProMedica locations and other research locations as needed. Option for hybrid remote work schedule after orientation.

The above list of accountabilities is intended to describe the general nature and level of work performed by the positions; it should not be considered exhaustive.

Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or other status protected by applicable law.

Equal Opportunity Employer/Drug-Free Workplace

**ProMedica** is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus (https://www.promedica.org/Pages/about-us/default.aspx) .

Benefits:

We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It’s what makes us one of the best places to work, and helps our employees live and work to their fullest potential.

Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact **[email protected]**

Equal Opportunity Employer/Drug-Free Workplace