Research Validation Specialist - Rush Office of Research Affairs

Rush University Medical Center - Chicago, IL

Full-time
Job Title: Research Validation Specialist - Rush Office of Research Affairs

Department:
Shift: 1st
Specialty: Research
Job Number: 2019-3260
Date Posted: 10/15/2019
Position Type: Research

Job Qualifications:
At Rush University Medical Center, 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 Research Validation Specialist position with the Office of Research Affairs at Rush University Medical Center.

Position Highlights:
This position 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

Position Responsibilities:
Reviews coverage analyses, negotiated budgets, negotiated contracts, IRB approved informed consent forms, regulatory approvals, and other relevant documents with particular focus on compliance with government, sponsor, legal, and institutional policies and procedures for clinical research studies.
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 documents and ensures documents are ready for signature by institution's authorized signatory.
Monitors business problems related to the synchronization process and consults with senior sync specialist and Manager to troubleshoot.
Acts as a main point of contact for principal investigators and study teams on all research related synchronizations and provides regular updates to study teams as requested.
Participates in training for faculty and staff to ensure compliance with institutional, sponsor, and federal regulations related to synchronization for research.
Assists in maintaining a library of pre-approved form documents, contract clauses, templates, historical documents, and adds or revises material as needed.
Makes recommendations and potentially drafts standard operating procedures related to synchronization for the Office of Research Affairs.
Is aware of synchronization turnaround times with a focus on streamlining the review process.
Gathers 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.

Required Position Qualifications:
Bachelor's degree and 3-4 years of related clinical research experience OR 7 clinical research experience.
Knowledge of the life cycle of a clinical trial, including coverage analysis, research revenue cycle, and research budgeting.
Must demonstrate proficiency with the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and HIPAA.
Ability to function efficiently and effectively in high stress situations
Ability to exercise sound judgment and appropriately seek guidance from Counsel when necessary.
Ability to aptly assess potential regulatory, compliance, or legal risks / exposure
Strong interpersonal skills.
Clear and concise written and verbal communication skills.
Detail oriented.
Strong analytical skill with a high attention to details.
Ability to meet deadlines.
Microsoft Office Suite

Preferred Job Qualifications:
Relevant certification (i.e. CCRP, CIP, etc.)

Company Highlights:
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.

At Rush University Medical Center, 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 Research Validation Specialist position with the Office of Research Affairs at Rush University Medical Center.

Position Highlights:
This position 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

Position Responsibilities:
Reviews coverage analyses, negotiated budgets, negotiated contracts, IRB approved informed consent forms, regulatory approvals, and other relevant documents with particular focus on compliance with government, sponsor, legal, and institutional policies and procedures for clinical research studies.
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 documents and ensures documents are ready for signature by institution's authorized signatory.
Monitors business problems related to the synchronization process and consults with senior sync specialist and Manager to troubleshoot.
Acts as a main point of contact for principal investigators and study teams on all research related synchronizations and provides regular updates to study teams as requested.
Participates in training for faculty and staff to ensure compliance with institutional, sponsor, and federal regulations related to synchronization for research.
Assists in maintaining a library of pre-approved form documents, contract clauses, templates, historical documents, and adds or revises material as needed.
Makes recommendations and potentially drafts standard operating procedures related to synchronization for the Office of Research Affairs.
Is aware of synchronization turnaround times with a focus on streamlining the review process.
Gathers 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.

Required Position Qualifications:
Bachelor's degree and 3-4 years of related clinical research experience OR 7 clinical research experience.
Knowledge of the life cycle of a clinical trial, including coverage analysis, research revenue cycle, and research budgeting.
Must demonstrate proficiency with the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and HIPAA.
Ability to function efficiently and effectively in high stress situations
Ability to exercise sound judgment and appropriately seek guidance from Counsel when necessary.
Ability to aptly assess potential regulatory, compliance, or legal risks / exposure
Strong interpersonal skills.
Clear and concise written and verbal communication skills.
Detail oriented.
Strong analytical skill with a high attention to details.
Ability to meet deadlines.
Microsoft Office Suite

Preferred Job Qualifications:
Relevant certification (i.e. CCRP, CIP, etc.)

Company Highlights:
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.