Associate Research Compliance Officer

Primary Function

The Associate Research Compliance Officer is part of the CNE Compliance Services team and reports to the Vice President of Compliance & Privacy.

The Associate Research Compliance Officer also has an indirect reporting relationship and works closely with the Senior Director of Research Administration.

The Associate Research Compliance Officer will support and advance the CNE Compliance Program for Research & Integrity and play an integral role in managing the Financial Conflict of Interest industry interactions program.

This role is responsible for development and managing the seven elements of an effective compliance program that includes but is not limited to Risk Assessments, Policies and Procedures, Training and Communication, Confidential Reporting Structure, Auditing and Monitoring Process, and Third-Party Management.

This continuous improvement of academic research oversight of compliance activities will be conducted within the requirements of CNE’s policies. Specifically, frequently interacts with research staff and key stakeholders throughout CNE to provide advice and guidance on the policies relating to conflicts of interest and commitment in research, identifies issues and risks for consideration by the Financial Conflict of Interest Committee, and other issues as they arise. This role will serve as a liaison between Research Operations and Research Compliance utilizing tact and diplomacy to communicate, build rapport, and foster a culture of compliance and form a strategic approach to the Research Compliance Function.

Key Responsibilities:
1. Administers and assists the Vice President, Chief Compliance & Privacy Officer with the seven elements of an effective compliance program, including but not limited to managing the process for receiving, documenting, tracking, investigating, and taking action on Research Compliance matters in coordination with other functions and, when necessary, legal counsel.
2. Responsible for managing CNE’s Annual Conflict of Interest and Research Financial Conflict of Interest process.
3. Support the Research Compliance function to conduct an annual research compliance risk assessment and develop annual work plan to address identified risks, including conducting audit and monitoring activities.
4. Responsible for the timely intake and review of financial disclosures and outside activity agreements research staff that may pose conflicts of interest with research under institutional policies and sponsor regulations.
5. Participate in the administration, testing, updating, and operation of the online conflict of interest disclosure system and database.
6. Responsible for providing information and supporting the Conflict of Interest Committee, including but not limited to Identify cases, trends, and issues for committee consideration.
7. Responsible for the identification and review of institutional interests that may pose conflicts of interest with research under institutional policies.
8. Answer questions via email or phone from research staff, directors, administrators, other internal customers or external academic affiliates regarding conflict of interest policies and processes in formal and informal settings. Facilitate compliance with institutional policies by enabling these individuals to understand policy requirements.
9. Contribute to the development of Research Compliance policies, procedures, and guidelines.
10. Participate in the design and delivery of training and website content relating to research compliance, conflicts of interest and other relevant policies, etc.
11. Participate in tracking completion of Research Compliance training.
12. Monitor updates and changes in sponsor requirements and maintain a current and in-depth understanding of policies and regulations regarding research conflicts of interest.
13. Enhance professional growth and development by participating in educational programs, distributing and reading current literature and conducting and participating in in-service meetings and workshops.
14. Comply with office practices that support the efficient operation and documentation of the Research Compliance & Integrity Program.
15. Perform other duties as assigned by the supervisor.
Minimum Job Qualifications:
1. Bachelor’s degree required; preferably in a scientific or legal field
2. 4 years of experience with conflicts of interest, research compliance, or comparable regulatory experience
3. Demonstrated ability in utilizing independent judgment; must possess knowledge about conflict of interest regulations and practices and have the ability to identify issues and problem solve in a deadline driven environment.
4. Requires in-depth knowledge about conflict of interest regulations and practices
5. Certification/Licensure: Certification in Healthcare Compliance (CHC) and Certified in Healthcare Research Compliance (CHRC).

Requirements:
1. Relevant post-graduate education (e.g., JD, Master’s, PhD) preferred but not necessary
2. Experience at an academic, research, or hospital setting (such as grants management, clinical trial management, or research administration)
3. Background in science or medicine is an advantage
4. Must have the ability to identify issues and to strategize to improve processes
5. Previous use of Conflict of Interest software desired.

I. Knowledge and Skills:

1. Knowledge and experience with general health care compliance preferred
2. Strong organizational, interpersonal and analytical skills and the ability to function effectively in a fast-paced environment
3. Position requires strong administrative skills, including use of computer software
4. Ability to prioritize multiple projects and work independently
5. Must have excellent customer service skills
6. Must be able to exercise judgment in making decisions
7. Able to interact effectively with all colleagues and management and effectively work with and coordinate the activities of multiple departments
8. Ability to anticipate potential issues and proactively respond
9. Good judgment and problem solving skills
10. Ability to maintain confidentiality
11. Must be adept at follow up, team work and be detail oriented
12. Responsible for the accuracy and timeliness of own work
13. Is knowledgeable with state and federal regulatory and legal requirements and has the capability to research effectively.

II. Planning, Productivity and Decision Making
1. Develop Key Performance Indicators (KPI) and measure progress against set goals.
2. Develop Management reports to inform CCPO of performance and adjust KPIs as initiatives emerge.
3. Effectively prioritizes own work in order to complete job responsibilities. Displays ability to adjust priorities based upon understanding of policies and procedures.
4. Completes job responsibilities within required timeframe, according to established schedules or workflow requirements.
5. Displays an ability to evaluate areas in need of improvement and provides input in order to improve current methods, services, programs or technology.
6. Reviews and assesses information before making decisions and solving problems.
7. Can assess when additional information or direction is required which may include collaboration with supervisor or other subject matter experts.
8. Uses proper judgment and knowledge of established practices and procedures when addressing problems or issues.
III. Customer Service
1. Establishes and maintains effective relationships with customers, gaining their trust and respect.
2. Anticipates customer needs and proactively addresses them.
3. Understands the customer’s business and the importance to the organizations mission.
4. Is dedicated to meeting and exceeding the expectations and requirements of internal and external customers.
5. Follows the established procedures and effectively uses tools to provide high level support to customers.
6. Communicates effectively with internal and external customers with respect of differences in cultures, values, beliefs and ages, utilizing interpreters when needed.
IV. Teamwork
1. Demonstrates an ability to work well with employees at all levels across Care New England.
2. Contributes information, ideas and opinions in a group setting.
3. Volunteers for team assignments or group problem solving.
4. Represents own ideas and solutions while acknowledging and/or accepting ideas and solutions of others.

V. Communications
1. Written communication is clear, concise and professional as well as appropriate to the recipient.
2. Verbal communication is clear, professional in tone, non-threatening and appropriate to the recipient.
3. Is attentive, actively listens and can accurately relay information.

VI. Personal Development
1. Maintains professional growth and development.
2. Participates in taskforces and committees.
3. Attends seminars, workshops and conferences as appropriate.