Job Details

Clinical Contracts Specialist

Company name

Providence Health & Services.

Organization Type

Public Interest

Job Type

Non-practicing Attorney

Valid Through

Sep 03, 2020

Posted on

May 21, 2020

Years of Experience

Min 2 yrs required

Location

Portland, OR, United States

Employment Type

Full-time

Industry

Legal
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Clinical Contracts Specialist
The candidate will be responsible for the review or preparation, tracking and finalization of the clinical trial agreements, amendments, and confidentiality agreements in the System-level research contracts hub model. This position reports to the hub-level Manager and includes collaboration with several research entities within Providence and Swedish to address research-specific challenges. Main responsibilities include, but not limited to, the review and negotiation of clinical trial agreements/amendments with industry sponsors, meeting the standards of PH&S, FDA, OIG, and other regulatory agencies; development of clinical research agreements for investigator-initiated studies; processing of all agreements for execution; close interactions with finance and regulatory staff. Must uphold the standards of confidentiality, attendance and punctuality. The incumbent performs all duties in a manner that promotes Providence mission, values, and philosophy. In all aspects, he/she serves as a role model for the values and mission of the organization. Responsible for the review of clinical trial agreements and amendments with industry sponsors and other sponsoring organization ensuring compliance with Providence’s internal procedures and meet requirements of FDA, OIG, and other regulatory agencies. Ensure agreements with non-Providence physicians are negotiated in alignment with Clinical Trial Agreements as necessary and are approved by Providence physician contracting team. Closely monitor status of outstanding agreements/amendments and budgets, and provide weekly updates to appropriate teams. Process all agreements for execution, ensuring that the appropriate departments receive a copy. Provide support to individual physician investigators and other Clinical Trials team members to ensure compliance with internal procedures and systems. Establish and promote positive working relationships within the department, throughout the hospital and between other institutions involved in clinical research. Assist in internal audit and help identify process deficiencies. Serve as a resource to study teams for interpretation of study language insertion and contract related issues. Provide adjudication on contractual requirements for amendments to study agreements based on changes to study related activities. Work closely with financial teams who are preparing the budgets and financial coverage analysis. May involve actual budget negotiation with sponsors. Perform other duties as assigned.

Qualification and Experience

The candidate should have 2 years of experience in a contract administration environment in an academic, pharmaceutical or biotech company or law firm. Strong knowledge of general research contract law, research regulatory guidelines and policies relevant to clinical research contracts is needed. Excellent negotiation and written/verbal communication skills is needed. Should have ability to work independently, creative thinking and problem solving skills. Must have good organization and planning skills, proven ability to handle multiple priorities and work independently. Proficiency with MS Word, Excel, Access and Outlook; comfortable with a variety of database applications is needed. Should preferably have Bachelor’s degree in Business Administration, Finance, or related discipline OR Paralegal certification required. MPH, JD, or MBA. Research Administration experience is preferred.

Additional info

Req ID: 258356

Company info

Hiring Coordinator
Providence Health & Services.
4805 NE Glisan St
Portland, OR 97213

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