Research compliance specialist job description

Trinity Health Of New England is looking for a Lab Revenue Compliance Specialist to join our team of mission-driven healthcare innovators in our Laboratory Services Department located at Saint Mary's Hospital in Waterbury, CT. Our vision is to provide state-of-the-art healthcare to those within our local communities, creating a positive impact for each individual that walks through our doors. Under the direction of the Laboratory Manager/Director, is responsible for the day-to-day operation of the laboratory compliance program. Works with the laboratory leadership team to design and implement a laboratory compliance program that assures laboratory practice complies with Federal and State laws, accreditation requirements to include laboratory personnel activities that involve billing, and reports and records surrounding confidentiality. Provides education to the laboratory staff, physicians and other clients of Trinity Health of New England Regional Laboratory Services on laboratory compliance with federal, state and organizational requirements. Continually assesses potential risk areas and updates the compliance plan, as necessary. Collaborates with colleagues across the organization to identify and improve billing processes to enhance revenue.
**Top Reasons to Work at Trinity Health of New England:**

• Become a valued member of an excellent, dedicated health care team

• Opportunity to work closely with leaders in implementing changes

• Competitive Benefits Package

**Position Hours:**

40 hours, Day shift, 8am-4:30pm (M-F)

**_You Will Be Responsible For:_**

+ **Exceptional Planning** & **Communication** : Responsible for the day-to-day operation of the hospitals compliance program. Works with the laboratory management team to continuously evaluate the effectiveness of the laboratory compliance program **.** Collaborates with colleagues across the organization to identify and improve processes to ensure all patient data elements are present and accurate for timely billing and resolves impediments. Acts as a resource to internal and external customers regarding the billing process. Escalates unresolved matters to the Regional Director. Communicates with patients who have questions on their laboratory bill and/or insurance payment. Resolves billing issues and complaints.

+ **Strong Educator:** Provides education to the laboratory staff, physicians and other clients of Trinity Health Of New England Regional Laboratory Services on laboratory compliance with federal, state and organizational requirements. Continually assesses potential risk areas and updates the compliance plan as necessary. Develops educational programs to assist in training clients. Acts a resource to client services and the sales and marketing team. Orientations and trainings to include Nursing, Medical Student Orientations and Blood Culture Contamination Report. Sunquest and EPIC BEAKER onboarding orientation for new hires.

+ **Technical Familiarity:** Quality reporting and tracking to include Quality of Care reports to Hospital. Tier 1 rounding and reporting of data on the Tier 1 dashboards. Remains apprised of revisions to applicable regulatory guidelines relating to federal health care programs (Medicare and Medicaid). Communicates changes in regulatory guidance to those affected by the change both within the organization and with outside accounts, as necessary. Understanding in the computer-based applications (email, and standard applications such as Microsoft Office).

+ **Active Teamwork** : Demonstrates problem solving, conflict resolution, and positive communication through teamwork. Understands and participates in the development of processes for payer specific policies. Must work with Team Leads, Supervisors, Managers and Director to standardize policies and procedures, competency assessments and workflows.

**_What you need:_**

+ **Education:** Medical Technologist (ASCP) or BS/ BA degree; Master's Degree in Business Administration or Health Administration preferred.

+ **Experience:** Minimum five (5) years as a Medical Technologist or Hospital Billing experience and three (3) years working in laboratory compliance. Must have knowledge of laboratory compliance and billing including outreach facilities. Requires knowledge of HIPAA, and state and federal privacy regulations. Working knowledge of office/administrative procedures and standard equipment and computer programs (Word, Excel MS Office, LIS, EPIC, Beaker and CoPath).

+ **Certification:** ASCP Certification preferred; Certified in Healthcare Compliance and/or Certified in Healthcare Privacy preferred. Combination of education and work experience may be considered.

+ **Job Skills** : -In depth knowledge of clinical laboratory operations, medical terminology, laboratory CPT codes and ICD 10 coding. Requires in depth knowledge of laboratory, hospital and skilled nursing facility billing regulations as related to laboratory services. Thorough knowledge of the Office of the Inspector General's Compliance Program Guidance for Clinical Laboratories and strong understanding of privacy regulations as they relate to laboratory operations.-Highly analytical with the ability to gather and summarize data for reporting and finding solutions to billing and privacy concerns. Has the initiative to develop and implement new processes for improvement.-High level of interpersonal skills to handle sensitive/confidential situations and to maintain poise, tact, diplomacy and collaboration. Must be able to communicate with all levels of the organization.-Strong organizational and time management skills with the proven ability to multitask and manage complex projects to minimize risk and enhance revenue.

**_About Trinity Health Of New England:_**

Trinity Health Of New England is an integrated health care delivery system that is comprised of world-class providers and facilities dedicated to full spectrum preventative, acute, and post-acute care. We aim to deliver top level care to increase our community's overall health at lower costs. While we serve nearly 3 million people, we are proud to be a part of a national system that focuses on putting our patients first and having the best colleagues to do so.

Trinity Health Of New England benefits include health insurance, adoption assistance, tuition reimbursement, paid vacation, sick time, and professional advancement just to name a few.

Employees can also take advantage of extra benefits specific to each hospital.

**Step up to your potential. Write your story and apply today!**

**Our Commitment to Diversity and Inclusion**

Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.

How to Apply

A cover letter and resume are required for consideration for this position; include the cover letter as the first page of your application. The letter should specifically address your interest in this position and outline relevant skills and experience.

Summary

The University of Michigan Office of the Vice President for Research (OVPR) is seeking a compliance specialist to provide support for the Export Control Program and the Research Information Security Oversight Program. The position requires excellent attention to detail and the ability to effectively manage competing high priority tasks. The position will report to the Export Control Officer.

Responsibilities*

Key responsibilities include, but are not limited to the following:

* Schedule meetings for the Export Control Review Committee and Controlled Unclassified Information Governance Committee and take notes for the meetings.
* Serve as resource and liaison for faculty and administrators to Export Control Program and IT Security Oversight Program.
* Draft documents, including business process documents, approval letters, agendas and correspondences.
* Provide initial review and triage of eResearch proposals for export controls and IT Security.
* Read and interpret sponsored research agreements as well as the Export Control regulations and the National Institute of Standards and Technology regulations.
* Independently manage restricted party screening process in Visual Compliance and analyze the different U.S. government lists and understand how they apply to U-M.
* Oversee the implementation of enhancements to export controls and IT security training initiatives, including refinement of training tools and guidance documents.
* Draft IT security management plans.
* Work directly with principal investigators and research administrators to identify export controlled research projects and projects involving IT security and assist with completion of Technology Control Plans and IT Security Plans.
* Analyze I-129 visa reviews from the International Center, requiring contract interpretation, application of export control regulations and a written analysis in each case.
* Maintain and update Standard Operating Procedures (SOPs), reference files and Export Controls Program and Controlled Unclassified Information Program websites.
* Willingness to learn how to classify items under the Export Control Regulations.
* Attend export control and IT security conferences for training, as needed.

Required Qualifications*

* Bachelor's degree preferred or equivalent combination of education and experience.
* Several years of previous administrative experience.
* Outstanding attention to detail and excellent organizational skills.
* Ability and desire to work as part of a team along with the proven ability to self-start and show initiative.
* Demonstrated ability to initiate activities and carry them through to completion as well as the flexibility to change focus and priorities quickly.
* Experience calendaring and preparing materials for committee distribution.
* Demonstrated ability to navigate complex web-based systems
* Experience handling highly confidential and sensitive information with a demonstrated ability to use sound judgment and diplomacy.
* Strong interpersonal skills along with excellent oral and written communication.
* Excellent computer skills including solid working knowledge of Microsoft Word, Excel, Power Point, Google workspace and Adobe Creative Suite.

Desired Qualifications*

* 5 or more years of previous administrative experience.
* Experience with research, research compliance or research administration.
* Work experience in a higher education setting.

Background Screening

The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible

The Research Compliance Specialist will be responsible for developing, maintaining, and/or enhancing research compliance programs for the Glendale, AZ campus and will report to the Associate Director, Office of Research & Sponsored Programs (ORSP). The position will assist with federal and state regulation compliance governing research and will work closely with the university's Biosafety Committee (BSC). The Research Compliance Specialist will serve as a resource to assist faculty and staff in the day-to-day operations of research-related activities, to ensure those activities are accomplished in a compliant manner.
Essential Duties and Responsibilities

+ Identifies compliance issues and establishes procedures that foster research performance compliant with federal regulations, state laws and internal policies.

+ Assists with the development, implementation, maintenance, and/or enhancement of a wide variety of research compliance issues, including:

+ Liaise with the Director of Occupational Health and Safety as it relates to the Hepatitis B Program to ensure compliance with OSHA Bloodborne Pathogens Standard for research labs, where applicable.

+ Annual Laboratory registrations

+ Time and Effort Reporting

+ Responsible Conduct of Research

+ Biosafety

+ Import and Export Controls

+ Compliance with NIH, NSF, OSHA, EPA, etc. regulations and guidelines related to research

+ Provides administrative support for BSC and works closely with the Committee Chair to review and process protocols involving hazardous biological materials or chemicals.

+ Enhances MWU's biosafety program by working with research faculty to ensure the use of hazardous materials in each research lab are approved by the BSC, proper signage is posted, chemical inventories/ebinders are maintained and current on Material Safety Data Sheets (MSDS) Online, tracks biosafety levels applicable to each lab appropriate to their specific risk levels;

+ Assists faculty and works closely with the BSC Chair to ensure research involving recombinant or synthetic nucleic acid molecules (rs NA) are submitted to the IBC for review and approval.

+ Enhances MWU's radiation safety program by overseeing the performance of swipe testing, radiation badge monitoring, etc. in the event radioisotopes are used on the Glendale campus;

+ Enhances MWU's research safety programs by ensuring campus safety manuals, e.g. Lab Safety Manual, Bloodborne Pathogens Exposure Control Plan, Chemical Hygiene Plan, Radiation Safety Handbook, etc. are maintained and accessible to researchers.

+ Liaise with the Research Administrator on Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) studies that involve a biosafety or chemical safety component requiring review by the Biosafety Committee to facilitate concurrent reviews.

+ Plans and assists with research laboratory inspections.

+ Assists in the development and tracking of resesarch compliance education and training for all research faculty, staff and students to comply with laboratory safety training requirements.

+ Approves research laboratory access once all lab safety training requirements have been completed.

+ Coordinates Time and Effort reporting for federally funded grants in conjunction with Business Services.

+ Assists the Associate Director of ORSP with oversight and coordination of intramural grant proposals, e.g. Faculty Seed Grant, One Health Grant, and Improving Health Care Delivery Grants.

+ Improves MWU's effort reporting for grants by documenting training for all who sign off on effort reports, and by tracking effort reports for all grant recipients, such that all effort reports are turned in and filled out appropriately and on time;

+ Develops and supports effective lines of communication and advocacy which promote the reporting of research compliance concerns, to ensure that all of MWU's research compliance programs have adequate financial and physical resources to perform the functions assigned to them;

+ Ensures that compliance issues are handled in a timely and appropriate manner;

+ Ensures that regulatory and policy updates are disseminated to investigators and research staff in a timely manner, performs ongoing monitoring of research compliance areas, acts decisively with recommendations on how to handle concerns about potential non-compliance, and provides reports on monitoring activities to the Associate Director of ORSP;

+ Actively seeks current compliance information and makes recommendations for required changes to MWU's programs as needed.

+ Oversees emergency and scheduled usage of the ORSP backup freezer;

+ Develops and maintains a comprehensive Responsible Conduct of Research training (RCR) program that meets the requirements for National Institutes of Health (NIH) and National Science Foundation (NSF) trainees. Informs faculty of RCR training program and requirements to ensure training delivery;

+ Liaises with the Director of Occupational Health and Safety to facilitate researchers into the Respiratory Protection Program, and Hepatitis B Program, as needed.

+ Enhances MWU's export and import controls through tracking required training for faculty and staff shipping biological materials;

+ Works with the BSC Chair, Director of Occupational Health and Safety, and Risk Management to establish and/or maintain prudent practices that comply with regulations regarding research-related: accident reviews, training/education, injury and illness records, waste management, and related record-keeping;

+ Works with appropriate college representatives and research faculty to ensure that research-related biological, and chemical hazardous waste, sharps, and radioactive waste are each disposed of in a manner compliant with applicable regulations. Assists with development and implementation of the best service-oriented manner to incorporate compliance-related activities on MWU's Glendale campus.

+ Assists with other research-related assignments, as instructed by the ORSP Associate Director or Assistant Vice President of Research.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be organized, a good communicator, possess strong record-keeping skills, and able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. This individual must be able to work in a constant state of alertness and safe manner and have regular, predictable, in-person attendance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

A Bachelor's degree is required. Must have a minimum of 3 years of experience related to research administration or research compliance. Must have excellent verbal and written communication skills with the ability to advance multiple compliance projects simultaneously. Previous experience with Occupational Health and Safety, Respiratory Protection, Responsible Conduct of Research training, Biosafety, Time and Effort Reporting and Export Controls is preferred. Previous experience in the interpretation of regulations, policies, procedures, and ethical principles in research compliance is preferred. Must have the ability to develop regulations into operational policies and procedures.

Computer Skills

Computer proficiency in MS Office (Word, Excel, Outlook).

Language Skills

Intermediate skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Reasoning Ability

Intermediate skills: Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Mathematical Ability

Basic skills: Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to interpret bar graphs.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is frequently required to sit, talk and hear. The employee is regularly required to walk, and reach with hands and arms. The employee is occasionally required to stand, use hands to finger, handle or feel. The employee must regularly lift and /or move up to 25 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.

Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with all federal, state and local laws, including 41 C.F.R. 60-1.4(a), 250.5(a), 300.5(a) and 741.5(a). Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/). Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.

Qualifications

Education

Required

+ Bachelors or better

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)