A highly reputable and distinguished clinical research organization is currently hiring for a Senior Clinical Research Validation Specialist to work in Chicago, IL.
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 company mission, vision and values and acts in accordance with policies and procedures.
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Assists in maintaining a library of pre-approved form documents, contract clauses, templates, historical documents, and adds or revises material as needed.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.
Aware of synchronization turnaround times with a focus on streamlining the review process.
Gathers monthly metrics on synchronizations submitted to the Office of Research Affairs.
Maintains up-to-date status for all synchronization submitted in the Research Portal.
Other relevant duties and projects as assigned.
Required Position Qualifications:
Bachelor’s Degree and related 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.
Strong analytical skill with a high attention to details.
Ability to meet deadlines.
Microsoft Office Suite
Preferred Position Qualifications:
Relevant certification (i.e. CCRP, CIP, etc.)
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.