Research Accountability Specialist

Job Summary

The Research Accountability Specialist will support the compliance efforts of the Research Institute (RI) and the Corporate Compliance Office in conducting conflict of interest (COI) and compliance reviews and audits, reporting on compliance activities within the Research Institute, updating and verifying RI policies and procedures to comply with federal and state laws and regulations and supplementing the activities of the Research Billing and Data Systems Coordinator. In collaboration with the BH RI Leadership Team, the Research Accountability Specialist will develop and implement research compliance processes, investigate and communicate details of research laws and regulations, participate with RI leadership in the annual Research Institute assessment of risks, manage the Research Compliance Plan and program recommendations, and assist in the development of research compliance education. The Research Accountability Specialist will serve as the RI Compliance Risk Coordinator (CRC) and represent the RI at CRC meetings and the annual Department Compliance Risk Coordinator in-service. The Research Accountability Specialist will also assist, as assigned, in the implementation and execution of the RI Compliance Plan in the corporate BWise system. an Enterprise Risk Management system at the local level.

Essential Functions

All activities are subject to the direction and control of the Director of Research Regulatory and Billing and the Administrative Director of the Research Institute with specific guidance from the Research Institute Compliance Committee.

Serves as a role model for good business practices embracing the Code of Conduct, service excellence and quality.

Manages the Research Institute COI Program, including administration of the electronic system for the Research Institute, coordination of system forms and activities with the designated Corporate Compliance Manager, identification of participants, review of positive disclosures (under the direction of the Research Institute Compliance Committee), development of COI management plans, documentation of reviews and plans and oversight of support staff facilitating access and preparing daily reports.

Monitors/investigates/recommends action on matters involving:a. RI operational performance related to compliance;b. Unethical conduct;c. Research, billing, coding, claims, and/or payment;d. Compliance with state and federal regulations as applicable to the RI and research conducted at BH; ande. Inquiries and complaints made to the Research Compliance Office.

Maintains logs, in accordance with identified processes, of calls, inquiries, and/or complaints relating to research at Beaumont, with actions taken Researches and analyzes federal and state laws and regulations, pronouncements such as the Common Rule, HIPAA, OIG fraud alerts. Assists groups with implementation of responsive measures to better ensure BH compliance.

Provides research compliance training with documentation of content and attendance.

Conducts quarterly revenue compliance audits related to research billing and claims submission, reimbursement to physician practices for research services and quality of care requirements for participants covered by CMS; prepares report for the corporate Revenue Compliance Committee.

Monitors CMS Open Payments Database to ensure industry relationships are appropriately disclosed. Prepares reports for various committees as appropriate.

Works cooperatively with members of the RI leadership team. the privacy, security, and compliance audit teams.

Participates in interdisciplinary teams in resolving compliance issues.

Conducts/coordinates audits of:a. Research compliance with the AAHRPP accreditation requirements for contracting.b. Compliance with PHS requirements relating to promoting objectivity in research, including COI training and the entire COI disclosure/review/mitigation process.c. Compliance with NIH Grants policies and processes to ensure proper acquisition, handling and accounting for gift cards for study stipends.d. Compliance with AAALAC accreditation requirements for the Occupational Health Plan for Research Services.e. Compliance with research data security policies for data storage.f. Other risks areas as they are identified.

Will be expected to promptly respond to questions affecting BH’s compliance with applicable laws, regulations, and/or BH policies in coordination with the Compliance Leadership Team.

Traveling to sites for audits and investigations.

Completes other projects as assigned.

How Corewell Health cares for you

Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here (https://careers.corewellhealth.org/us/en/benefits-new) .

On-demand pay program powered by Payactiv

Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!

Optional identity theft protection, home and auto insurance, pet insurance

Traditional and Roth retirement options with service contribution and match savings

Qualifications

Required

Bachelors Degree in Healthcare Administration, Business Administration, Finance, a clinical health science or related field.

Strong working knowledge of federal and state laws and regulations as they pertain to clinical research, health care, coding and billing, and information privacy/security law and regulation is highly desirable.

CRT-Clinical Research Professional, Certified (CCRP) – SOCRA Society of Clinical Research Associates Or

CRT-Clinical Research Coordinator, Certified (CCRC) – ACRP Association of Clinical Research Professionals

Preferred

Candidates with experience in a well-established clinical research center.

Strong documentation and communication skills, including the ability to provide clear guidance and instruction; ability to understand and mitigate business risk analysis skills; ability to develop plans of correction to ensure regulatory compliance; strong attention to detail are highly desired traits.

In addition, knowledge of the Common Rule, PHS Objectivity in Research requirements and HIPAA Security and Privacy rules are desirable.

CRT-Healthcare Research Compliance, Certified (CHRC) – HCCA Health Care Compliance Association preferred

About Corewell Health

As a team member at Corewell Health, you will play an essential role in delivering personalized health care to our patients, members and our communities. We are committed to cultivating and investing in YOU. Our top-notch teams are comprised of collaborators, leaders and innovators that continue to build on one shared mission statement – to improve health, instill humanity and inspire hope. Join a nationally recognized health system with an ambitious vision of continued advancement and excellence.

Primary Location

SITE – Research Building – 3811 W 13 Mile Road – Royal Oak

Department Name

Research Institute Administration

Employment Type

Full time

Shift

Day (United States of America)

Weekly Scheduled Hours

40

Hours of Work

8:00 a.m. – 4:30 p.m.

Days Worked

Monday – Friday

Weekend Frequency

N/A

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Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.

Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.

An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.

You may request assistance in completing the application process by calling 616.486.7447.