Beth Israel Deaconess Medical Center Senior Research Compliance Specialist in Boston, Massachusetts
Senior Research Compliance Specialist
Job LocationBoston, Massachusetts
Req ID 17531BR
Department Description: The Office of Compliance and Business Conduct oversees the Research Compliance Program. The office works with employees, department and division administrators, physician leaders, and committees to meet the highest ethical standards in caring for patients, educating clinicians-in-training, and promoting health through basic and clinical research. BIDMC has a thriving research enterprise that contributes to the health of our patients and the body of scientific knowledge that benefits society. At BIDMC we uphold high standards of ethical research conduct, using good judgment, and acting responsibly.Job Location: Boston, MAReq ID: 17531BRJob 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, which include but are not limited to: animal care and use; clinical trials; international research; data protection and sharing; research involving bio hazardous agents; export controls; grants management; and controlled substances. The Senior Research Compliance Specialist promotes Research Compliance best practices and solutions.
Assist with development and implementation of the annual Research Compliance Work Plan and identification of performance indicators to measure the effectiveness of the research compliance program at BIDMC.
Conduct risk assessments, internal investigations and operational audits of research related issues to: monitor compliance with federal, state and local laws and regulations and BIDMC Policies and Procedures: identify potential research compliance vulnerabilities; and make recommendations to Director of Research Compliance to improve internal controls.
Develop and deliver research compliance training and education curriculum for BIDMC personnel; create training tools and materials (training aids, newsletters, brochures, handouts, etc.) on various research compliance related topics to achieve individual and group learning goals.
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.
Evaluate instances of non-compliance with further investigation and oversee follow up and resolutions including corrective action.
Bachelor's degree required. Master's degree preferred.
5-8 years related work experience required.
Knowledge of regulatory environment, especially in the area of research and federal funding.
Knowledge and/or experience in healthcare, especially in the area of academic medicine.
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.
- Research Compliance Certification
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.
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.
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.
Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.
Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
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.
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.
Physical Nature of the Job:
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