Providence Health & Services Clinical Contracts Specialist in Seattle, Washington
Providence St. Joseph Health is calling a Clinical Contracts Specialist to our location in Seattle, WA.
We are seeking a Clinical Contracts Specialist to 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.
In this position you will have the following responsibilities:
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;
Processes all agreements for execution, ensuring that the appropriate departments receive a copy;
Provides support to individual physician investigators and other Clinical Trials team members to ensure compliance with internal procedures and systems.
Establishes and promotes 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.
Works closely with financial teams who are preparing the budgets and financial coverage analysis. May involve actual budget negotiation with sponsors.
Performs other duties as assigned.
Required qualifications for this position include:
Bachelor’s degree in Business Administration, Finance, or related discipline OR Paralegal certification required. MPH, JD, or MBA
Minimum of 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.
Excellent negotiation and written/verbal communication skills.
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.
Preferred qualifications for this position include:
- Research Administration experience.
About the department you will serve.
Providence Strategic and Management Services provides a variety of functional and system support services for all eight regions of Providence Health & Services from Alaska to California. We are focused on supporting our Mission by delivering a robust foundation of services and sharing of specialized expertise.
We offer a full comprehensive range of benefits - see our website for details
As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence Health & Services is a not-for-profit Catholic network of hospitals, care centers, health plans, physicians, clinics, home health care and services guided by a Mission of caring the Sisters of Providence began over 160 years ago. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Job Category: Contracting
Req ID: 253432