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Education requirement: Bachelor's Degree
Experience Required: 2+ years
Union Representation: Non-Union (100)
Work Schedule: 8-4:30
Hours per pay period: 80
Job ID: 33234
Job Code: 5RI
Date posted: Jan 8, 2013
Supports all activities for Park Nicollet Institute’s (PNI) Institutional Review Boards (IRB) and the IRB for the Community Oncology Programs. Supports enhancement of PNHS and Community Oncology Programs physicians’ and associates’ research activities to ultimately improve the quality of patient care. Serves as a resource for all matters related to human research subject protection and compliance with applicable federal, state and local laws. Supports implementation of and serves as a resource for research education. Works with the IRB Administrator to direct the receipt, review, processing, and documentation of research studies conducted by PNHS. Supervises clerical staff, volunteers, and/or students on an as needed basis. Bachelor’s degree and minimum of two years of experience in a research or health-related field. Experience working in IRB administration and knowledge of federal regulations relating to IRBs and human subject research preferred. Proficiency in the advanced features of the IRB’s current computer software packages for word, excel, database management and PNHS e-mail. Administering and advising on all phases of IRB application process. Consulting on practices in keeping with ethical standards and relevant laws applicable to human research subjects. Strong organizational skills with high attention to detail. High degree of accuracy and ability to work under deadlines and effectively manage high volume workload required. Excellent interpersonal skills, ability to work well with individuals from different disciplines and backgrounds. Excellent verbal and written communications skills. Ability to work independently and to recognize when to seek direction and/or additional resources. Ability to prioritize and work on numerous projects. NIH or comparable certificate demonstrating course completion in human subjects research ethics. Willingness to pursue certification for IRB Professionals within three years of hire.
This position requires competency in the following tasks or skills in addition to the responsibilities stated in the job description.
Tasks and Responsibilities:
- Review, redline, draft language as needed and negotiate the terms of clinical trial agreements and other research-related contracts in accordance with Park Nicollet Health Services (PNHS) and Park Nicollet Institute (PNI) policies and standards.
- Communicate with key stakeholders, including Research Managers/Directors, the Director of Contract Management, industry sponsors, and other internal and external parties.
- Coordinate and manage the research contract review and negotiation process. Maintain a central contract document management and tracking system.
- Develop and implement tools and resources to organize and support research contracting and related functions. May lead projects related to such development and implementation.
- May also assist internal and external stakeholders with clinical trial budget development, review and negotiation.
Scope of Responsibility:
Provides dependable and quality compliance and operational support to PNI. Works closely with PNI Operations Group, PNHS Finance, PNHS Contract Compliance and research departments. Applies a considerable degree of job skills and established policies/procedures to perform a wide range of tasks. Develops new or improved processes. Works independently on assignments that are moderate to complex in nature, sets workload priorities and project parameters and is responsible to meet deadlines.
Bachelor’s degree, two-year business program degree, or paralegal certificate with two or more years of direct contract review, drafting and negotiation experience and demonstrated success in general project management. Research and/or clinical trial agreement-specific experience a plus.
- Ability to communicate professionally and effectively with internal and external staff and customers; strong verbal and written communication skills
- High level of attention to detail
- Excellent organizational/project management skills
- Ability to prioritize multiple tasks
- Ability to make appropriate-level decisions independently
- Ability to manage multiple projects under deadline pressure
- Must have experience handling confidential information
Rooted in suburban Minneapolis, Minnesota, Park Nicollet Health Services (PNHS) is an integrated health care delivery organization. The two largest entities that comprise PNHS are ParkNicolletMethodistHospital, a 426-bed community hospital located in St. Louis Park, and Park Nicollet Clinic, a 500-plus, physician multi-specialty group with 25 offices in Minneapolis and its southern, western, and northern suburbs. PNHS truly is an integrated system, as processes of care are designed and managed across these entities to optimize the delivery of care for the patients and communities served.
Park Nicollet Mission, Vision and Values
Our mission is to care for and support the health, healing and learning of those we serve.
Everyone caring, every day, creating with the individuals we serve, optimal health and greater value.
Excellence is the standard we apply to our work, achieving best possible outcomes and upholding the highest professional standards.
Caring is our heartfelt motivation to serve our patients and create the best possible experience.
Stewardship is our commitment to create ever greater value with the resources entrusted to us.
Joy is what we experience when serving our patients and each other through a job well done.
Learning is the way we continually improve and create knowledge and value that can be shared.
What makes us unique?
Park Nicollet Health Services is a strong, stable and organically grown multi-specialty group practice within the affluent and highly educated western TwinCity metropolitan area. PNHS has a long-standing commitment to quality, proficiency and stewardship, and has embarked on a pioneering effort to study, adopt and integrate the Toyota Production System’s Lean Methodology (Kaizen), enhancing previous gains realized from its Six Sigma efforts. Although PNHS has developed and engaged in strong business partnerships with local competitors, having a single hospital focus adds to its list of strengths and advantages. PNHS was one of the first integrated healthcare systems in the nation to adopt a unit medical record that is now electronic and ubiquitous.
To learn more about our organization, including our award winning care, please visit our website at www.parknicollet.com.