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Rush University Medical Center Research Compliance Specialist in Chicago, Illinois

Job Title:

Research Compliance Specialist

Department:

Regulatory Compliance

Shift:

1st

Full/Part:

Active Regular FT (72 to 80 hours per pay period)

Specialty:

Research

Job Number:

2023-0209

Job Description:

Research Compliance Specialist

Job Summary:

The Research Compliance Specialist serves as Corporate Compliance Department staff and is a key team member in RUSH's (Rush University System for Health) research compliance program to support its activities. At the direction of the Associate Vice President (AVP) of Research Compliance, the Research Compliance Specialist is responsible for education and audits to ensure RUSH faculty, staff, employees, and students engaged in research activities are compliant with all aspects of federal, state, and local policies and regulations governing research. Routine and for-cause audits are conducted to assure compliance with local Policy and Standard Operating Procedures (SOP's), Good Clinical Practice (GCP) and expectations for data accuracy and completeness. Audits include significant teaching/training with respect to the conduct of research according to Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), National Institutes of Health (NIH) and other regulations and standards that govern research. The position is responsible for helping to develop and implement remedial education programs in response to detected examples of non-compliance and or emerging regulatory changes. How to remedy insufficient awareness or understanding, to address uncertainties about how to translate policies and to set and monitor performance improvement goals. The position is also responsible for fielding and responding to ad hoc research compliance related inquiries, including investigations, monitoring and improvement activities and using judgement and expert knowledge to escalate issues to the AVP. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Job Responsibilities:

I. Implement and conduct the Evaluation Quality Improvement Program or EQuIP under the direction of the AVP of Research Compliance.

  • Develops, executes, and maintains audit schedules according to the needs of the project.

  • Schedules, prepares, conducts audits and assessments of research operations

  • Tracks, collects, and reports responses and provides corrective and preventative action plans according to project audit plan.

  • Provides timely feedback by means of the audit report and ensures timely completion of all audit related activities.

  • Participates in project training on the research process, as well as assisting as a coach/mentor in the development of less-experienced researchers.

  • Interprets regulations and guidance documents governing FDA, OHRP, ICH/GCP and applies the interpretation to daily work per the audit plan.

  • Ensures that all human subject or clinical trial audit reports are accurate and of the highest professional quality.

  • Assists the AVP in risk assessments and the preparation of any office-related work plans and/or reports.

  • Participates in selection of protocols based on risk matrix.

  • Evaluates the potential risk of compliance deficiencies related to audit outcomes.

  • Assists in the management of external audits by regulatory agencies or business partners.

  • Develops organizational metrics of audit finding reports for management as requested.

  • Reviews corrective action plans/audit responses for adequacy.

  • Assists with the creation of quality/compliance training programs and the delivery of training programs with research administrative departments.

  • Performs related responsibilities as required.

II. Research Compliance Program Office Operations

  • Administers general Research Compliance operations to ensure that core compliance activities are maintained, including intake of research concerns reported through the Compliance Hotline, and the review of research policies.

  • Participates in Research Compliance Communications to bring about awareness to the research community related to emerging regulations, policy, and procedural changes.

  • Assists with the creation of quality/compliance training programs for research and assists with the delivery of training programs with research administrative departments.

  • Supports the maintenance of the CITI Program and assists the research community with mandatory training.

  • Participates and maintains the Research Compliance Onboarding training sessions.

  • Participates and maintains a Responsible Conduct of Research (RCR) program for faculty and students.

  • Establishes the means to measure and report on the effectiveness of Research Compliance operations, to include the use of metrics and other data reporting methods indicating productivity and the accomplishment of goals and objectives.

  • Aids in the preparation of the annual Research Compliance workplan.

  • Assists the AVP in investigations including Research Misconduct investigations as needed.

  • Responsible for the development and oversight of Compliance publications, to include website, e-blasts, newsletter, and annual effectiveness report.

  • Other duties as assigned.

Required Job Qualifications:

  • Bachelor's degree

  • 3 years of Clinical Research experience on human subject research

  • Knowledge of IRB, federal regulations, and grants management as they pertain research and the ability to interpret and apply laws and regulations to ensure the research enterprise adheres to ethical standards and best practices.

  • Oral and written presentation skills and creating and implementing training programs.

  • Experience with internal investigations preferred.

  • Project management skills, including the ability to identify needs, develop action plans, and lead/manage projects to completion.

  • Excellent writing skills with the ability to create policies and procedures.

  • Exceptional communication skills, including the ability to interact effectively with all levels of employees within the organization and with representatives from outside regulatory agencies.

  • Ability to lead work groups.

  • Provide effective conflict resolution for sensitive matters that may arise.

  • Experience with Huron's Click Commerce or similar electronic research software ideal.

  • Intermediate- level computer skills related to data analysis (Excel, Access).

Preferred Job Qualifications:

  • BSN or background in nursing .

  • Masters 3-5 years of Clinical Research

  • 2 years QA Auditing Experience (GCP Auditing)

Company Highlights:

  • 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 University is known for its high-quality health care education, supportive learning environment, engagement with the urban community and forward-looking education approach.

  • Rush University is ranked 22nd on the Times Higher Education's 2016 list of the world's top 150 universities under 50 years of age.

  • Rush is an academic health system comprising Rush University Medical Center, Rush Copley Medical Center and Rush Oak Park Hospital.

  • Rush was recently ranked first for Quality and Accountability among US academic medical centers in a study conducted by the health care performance improvement company Vizient.

  • The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded Rush full accreditation for three years. Rush is one of the first academic medical centers in Illinois to receive this accreditation.

  • 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.

  • 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.

Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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