Specialist - Clinical Trials 8/31/2016
Rush University Medical Center
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Here at Rush University Medical Center in Chicago, Illinois, we are committed to advancing scientific medical knowledge through research. We are revitalizing our medical centers with an emphasis on productivity, transparency and accountability. Are you looking to be a part of the exciting, always evolving and expanding new developments in research here at Rush University Medical Center* Are you well experienced in working with a variety of group, single and industry oriented studies*
If this describes you, you may be the right candidate for the Specialist position in Research & Clinical Trials Operations-Research.
Under the direction of the Assistant Director, the Sync Specialist reviews coverage analyses, negotiated budgets, negotiated contracts, and IRB approved informed consent forms to ensure consistency with institutional policies and guidelines just prior to study activation. The incumbent exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Reviews coverage analyses, negotiated budgets, negotiated contracts, IRB approved informed consent forms and other relevant documents with particular focus on compliance with government, sponsor, and institutional policies and procedures.
Works with colleagues in the Office of Research Affairs and in the Clinical Departments to resolve inconsistencies with contractual language, the coverage analysis, the budget, or the informed consent form.
Issues final approval on synchronization of research related contracts and ensures contracts are ready for signature by institution's authorized signatory.
Monitors business problems related to the synchronization process and troubleshoots.
Acts as a main point of contact for principal investigators and study teams on all research related synchronizations and provides regular updates to study coordinators as requested.
Advises, assists, and trains faculty and staff to ensure compliance with institutional, sponsor, and federal regulations related to synchronization for research.
Develops and conducts educational workshops on related policy and procedures.
Assists in maintaining a library of pre-approved form documents, contract clauses, templates, historical documents, and adds or revises material as needed.
Drafts and develops policies, and standard operating procedures related to synchronization for the Office of Research Affairs.
Monitors synchronization turnaround times with a focus on streamlining the review process.
Provides monthly metrics on synchronizations submitted to Office of Research Affairs.
Maintains up-to-date status for all synchronization submitted in the Rush Research Portal.
Other relevant duties and projects as assigned.
Position Qualifications Include:
Master's degree in a relevant field required
Three or more years of related clinical research experience required.
Experience drafting regulatory, compliance, or legal documents required.
Ability to exercise sound judgment and appropriately seek guidance from Counsel when necessary.
Ability to aptly assess potential regulatory, compliance, or legal risks / exposure.
MS Office and general technology proficiency.
Strong interpersonal skills.
Ability to work effectively in a fast-paced environment with strong organizational skills and ability to work independently and produce exceptional work under deadlines.
Excellent written and verbal communication skills.
Ranked among the top academic medical centers in the country, Rush University Medical Center is an outstanding place to enhance your career. Everything we do centers on one goal: improving patient care.
Rush's 14-story hospital Tower is the cornerstone of the Rush Transformation, and is the symbol of a philosophy-an evolution in the delivery of patient-centered care.
Rush is a not-for-profit health care, education and research enterprise comprising Rush University Medical Center, Rush University, Rush Oak Park Hospital and Rush Health.
As an academic medical center, Rush University Medical Center in Chicago, Illinois, is committed to advancing medical knowledge through research. Investigators at Rush are involved in more than 1,600 projects, including hundreds of clinical studies to test the effectiveness and safety of new therapies and medical devices, as well as to expand scientific and medical knowledge.
Rush University Medical Center is a three time Magnet facility located in Chicago, IL www.rush.edu
Leading academic medical center, acute care hospital w/ 676 licensed beds
RUMC offers a competitive salary, outstanding benefits & the professional advantages of an environment that supports your development & recognizes your achievements.
Rush University is home to one of the first medical colleges in the Midwest and one of the nation's top-ranked nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research.
As one of the most popular cities in the nation, Chicago is a cultural, historical and diverse city. Located on the shores of Lake Michigan, Chicago in known for its nearly 200 distinct neighborhoods and its extensive park systems, along with its sports teams, museums and vibrant theater community.
Rush University Medical Center is an Equal Opportunity Employer that welcomes and encourages all applicants to apply regardless of age, race, sex, religion, color, national origin, disability, veteran status, sexual orientation, gender identity and/or expression, marital or parental status, ancestry, citizenship status, pregnancy or other reason prohibited by law.