Sr Research Compliance Specialist

Department Name and ID: Office of Compliance & Bus Con 01080260
Reports to (job title): SVP-Chief Compliance Risk&Priv
Grade: 11
Current Job Code: A2744
FLSA Status: Exempt - All per diem positions are considered Non-Exempt
Effective Date: 2014-02-18
Status: Final Approved

Job Summary: Working under the direction of the Director of Research Compliance, the Senior Research Compliance Specialist is responsible for contributing to the success of the compliance program by assisting with the development, oversight, and monitoring of the research compliance functions of BIDMC, through interpretation of BIDMC policy and local, state, and federal laws and regulations. The Senior Research Compliance Specialist should have a strong background in multiple areas including, but not limited to: bench and laboratory research, animal research; human subjects research; international research activities; data protection and sharing; research privacy; grants management; and controlled substances. The Senior Research Compliance Specialist maintains and enhances research regulatory knowledge by continuous review and exploration of external publications and resources. Contributes to BIDMC and Office of Compliance and Business Conduct initiatives to promote a positive work environment.

The following statements are intended to describe the general nature and level of work being performed by individuals assigned
to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of this position.

Primary Responsibilities:
1. Assist with implementation of the annual Research Risk Assessment and development of the Research Compliance Work Plan. Assist with development of metrics to measure program effectiveness. (essential)
2. Conduct internal investigations and operational audits to assess risk of research related issues, identify potential research compliance vulnerabilities; and make recommendations to improve internal controls. (essential)
3. Educate BIDMC research community on various research related topics to achieve compliance with learning objectives utilizing diverse communications styles such as Power Point presentations, writing articles, website development, in-person training sessions, handouts, infographics, etc. (essential)
4. Monitor 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. (essential)
5. Evaluate issues of non-compliance to include investigation, oversight, follow up, and resolution. (essential)
6. Interpret and provide guidance on operational and regulatory issues for the BIDMC research community. (essential)
7. Assist in the development and revision of written research compliance policies, procedures, and guidelines. (essential)
8. Maintain research compliance portal page with relevant research compliance information and resources by creating and updating content in collaboration with web development staff. (essential)
9. Utilize tact and diplomacy to communicate, build rapport, and foster strategic alliances within the research community. (essential)
10. Represents Research Compliance at research-related committee meetings such as Research Compliance Committee, Lab Safety Officers, Research Safety Committee, Research Administrator Mentoring Program, etc. (essential)

Required Qualifications:
1. Bachelor's degree required. Master's degree preferred.
2. 5-8 years related work experience required.
3. Knowledge of regulatory environment, especially in the area of federal research funding.
4. Knowledge and/or experience in healthcare, especially in the area of academic medicine.
5. Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web based applications. May produce complex documents, perform analysis and maintain databases.

Preferred Qualifications:
1.      Knowledge and/or experience in a research academic medical center.
2.       Research Compliance Certification (CHRC) or within 2 years of employment.

Competencies:
1. Decision Making: Ability to make decisions that are guided by precedents, policies and objectives. Regularly makes decisions and recommendations on issues affecting a department or functional area.
2. Problem Solving: Ability to address problems that are highly varied, complex and often non-recurring, requiring staff input, innovative, creative, and Lean diagnostic techniques to resolve issues.
3. Independence of Action: Ability to set goals and determines how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
4. Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
5. Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.
6. Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
7. Team Work: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments.
8. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.

Social/Environmental Requirements:
1. Work requires periods of close attention to work without interruption. Concentrated effort of up to 4 hours without break may be required.
2. Work requires constant response to changing circumstances and using new information to adjust approach and to quickly respond to new needs.
3. No substantial exposure to adverse environmental conditions
4. Health Care Status: NHCW: No patient contact.- Health Care Worker Status may vary by department

Sensory Requirements:
Close work (paperwork, visual examination), Monitor Use, Visual clarity feet, Conversation, Telephone.

Physical Requirements:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally. This job requires constant sitting, Fine Manipulation using both hands, Keyboard use, Endurance-working up to 5-6 hours without a break, frequent walking.

Regards,
Eleanor Kuszmar (formerly Greene) MS, CHRC, CRA
Sr. Research Compliance Specialist
Office of Compliance and Business Conduct
Beth Israel Deaconess Medical Center
109 Brookline Avenue, Suite 200
Boston, MA 02215
Phone: 617-667-1836
Email: xxxxxx@bidmc.harvard.edu

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