Clini Research Compliance Spec

2 weeks ago

Boston, United States Tufts Medical Center Full time

Job Profile Summary

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Administration duties: Supports the administration of research practices working to achieve the organization's practices goals, plans, priorities, and tracks investments, allocates resources and makes decision regarding research administrative activities. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An experienced level role that applies practical knowledge of job area typically obtained through advanced education and work experience. Works independently with general supervision, problems faced are difficult but typically not complex, and may influence others within the job area through explanation of facts, policies and practices.

Job Overview

This position, reporting to the Director, Clinical Research & Regulatory Operations, will oversee the review, development, implementation and monitoring of research policies and compliance matters across the research enterprise of Tufts Medical Center.

Works in conjunction with appropriate hospital departments and personnel including Research Investigators, Research Coordinators, Research Administrators, Compliance and Patient Billing personnel to ensure compliance in research billing and other research activities. This includes acting as project manager on programs to improve internal processes, assistance with Medicare Coverage Analysis (MCA), clinical research billing, COI processing and issues related to compliance with federal funding guidelines and issues of a general nature related to research compliance.

Engages in Quality Improvement and Quality Assurance projects regarding clinical research compliance. Develops and Provides training to Investigators, Research Coordinators, Research Administrators and other appropriate personnel on clinical research compliance issues.

Job Description

Minimum Qualifications:

1. Bachelor's degree in healthcare, business, finance, accounting, or other related field.

2. Five (5) years of experience in research administration and/or clinical research, billing compliance or related activities.

Preferred Qualifications:

1. Master's degree in healthcare, business, finance, accounting, or other related field.

Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. Oversees Process Improvement programs related to pre and post award clinical trials billing compliance.

2. Engages participation from appropriate hospital departments including, but not limited to, Compliance, Patient Financial Services and Finance

3. Works with appropriate staff, reviews charges in Epic and other systems, as may be necessary for subjects enrolled in clinical research studies to assure appropriate billing.

4. Works with Patient Financial Services to manage the denied claims list for any potential errors and resubmissions. This includes assisting, when necessary, to contact payers for reconsideration of denial status.

5. Facilitates MCA compliance and review process including:

- Assists responsible personnel in preparation of Medicare Coverage Analyses.

- Facilitates the creation and implementation of Standard Operating Procedures for program.

- Provides clear and concise recommendations to leadership regarding billing and MCA issues.

- Reconciles documents to establish compliance with MCA billing plan, informed consent, contract and other related documents.

6. Monitors developments and changes regarding the regulatory environment and assist with the interpretation of emerging federal, state and local laws and regulations, as it relates to the review and oversight of research compliance

7. Works with respective areas of Research Administration to develop, coordinate and maintain policies and procedures, and to maintain compliance-related education and training materials.

8. Works with Research Administration leadership to update Tufts MC Research policies and develop an annual plan to keep polices up to date.

9. Conducts initial COI compliance reviews and will assist in the development of COI management plans.

10. Prepares reports for leadership and administrators.

Physical Requirements:

1. Typical clinical and administrative office setting.

Skills & Abilities:

1. Strong analytical, management, customer service, and communication skills.

2. Ability to work within a team and manage clean handoffs.

3. Strong interest in healthcare, compliance, billing and clinical trials.

4. Familiarity with regulatory process for device trials and Medicare regulations.

5. Knowledge of Epic and Velos CTMS.

6. Knowledge in federal, non-Federal regulations and operating policies of sponsored research including OMB Circulars A-110 and A-21.

7. Knowledge of PHS Grants Policy Statement, OMB A-133 audit requirements and other federal compliance issues.

8. Knowledge of conflict of interest regulations, statutes and policies relative to Research Conflict of Interest (COI).

Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network. We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation by emailing us at careers@tuftsmedicine.org.

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