Research Informatics Contracts and Compliance Manager

Research Informatics Contracts & Compliance Manager

The Research Informatics Contracts & Compliance Manager provides contracts, regulatory, privacy, and security support for clinical and translational research activities. The position coordinates research agreements and IRB-related documentation, develops compliance policies and procedures, assesses risks associated with research technologies and data use, and supports security and privacy incident response. The manager works across Research Informatics, Legal, Research, Compliance, Information Security, and external partners to promote compliant data sharing and responsible research operations.

Primary Responsibilities

Develop and update applicable RIC system and compliance policies and procedures for state and federal regulatory compliance, in alignment with partner IT and security organizations.

Work with UMMS Associate General Counsel for Clinical Trials and Research and assist in drafting, updating, and evaluating internal and external contracts and agreements, including but not limited to memorandums of understanding (MOUs), business associate agreements (BAAs), statements of work (SOWs), data use agreements (DUAs) or master service agreements (MSAs).

Coordinate processes for data request delivery including reviewing, editing, modifying, validating documentation to conjunction with Internal Review Board (IRB) documentation, and coordinate follow up between data owners, requestors/customers, and Research Informatics developers.

Manage RIC-centric security and compliance activities, assisting partner IT and security organizations with System Security Plan implementations and guidance from an RIC perspective.

Provide security and compliance input and feedback to RIC management and engineers for technical designs and strategies in support of technology, clinical data warehouse, and infrastructure platforms.

Analyze and coordinate risk identification and review for system, architecture designs, applications, or software for use.

Lead in the investigation, and documentation of security and privacy incidents from an RIC perspective, as needed, in accordance with UMMS policies and procedures and the UMMS security and privacy teams.

Work closely with UMMS security, compliance and legal to align assist with HIPAA compliance and alignment with NIST 800 standards.

Support the IHC in its collaborations with external partners, and other Institutes and Centers on campus.

Mentor Research Informatics staff for security, compliance, and regulatory, knowledge and growth.

Foster a culture of collaboration, problem solving, innovation, continuous learning, and a one team mindset.

Represent the IHC Research Informatics Core in campus meetings, working groups, and strategic planning sessions.

Perform all other related duties as assigned.

Work Experience

Education & Experience
- Required

Bachelor's degree in Security Administration, Information Systems, Information Security, Computer Science, Biological or Health Sciences, law or related field.

At least three (3) years working within healthcare industry or federal health agency (e.g. hospital, university, federal government).

At least two (2) years' experience with privacy or compliance within regulated environments (e.g. federal government, HIPAA, FISMA, ITAR etc.).

Education & Experience
- Preferred

Master's, Juris Doctor or Doctorate degree in security administration, information systems, information security, computer science, biological or health sciences, law, or related field.

Experience with NIST 800-53, NIST 800-171 or ISO 27001 frameworks.

Knowledge, Skills, & Abilities

Strong interpersonal and excellent written and verbal communication skills.

Organized, with strong attention to detail.

Ability to handle multiple simultaneous tasks effectively.

Able to work independently, self-starter.

Ability to communicate effectively, both in writing and orally.

Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

Demonstrated commitment and leadership ability to advance diversity and inclusion.

Attention to detail and accuracy, with strong analytical and critical thinking skills.

Demonstrated effectiveness in a complex organizational environment

Benefits

Pay Range: $42.64 - $64.00

Other Compensation (if applicable):
Review the  UMMS Benefits Guide

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