Job Title: Director of Research Compliance
Job Number: 65494
Location: Cold Spring Harbor, NY, USA, US
Cold Spring Harbor Laboratory (CSHL) is seeking a Director of Research Compliance, which is a full-time, on-site position. The CSHL Director of Research Compliance (DRC) is responsible for providing regulatory guidance to the CSHL research community and overseeing and implementing CSHL research compliance programs related to human subjects, animal research, recombinant DNA (rDNA), biosafety, financial conflicts of interest (FCOI) and export control. The DRC reports to the Director of Research Operations, and is responsible for establishing standards and implementing procedures to ensure that research conducted at CSHL is in compliance with federal and state regulations, as well as CSHL policies.
CSHL is primarily a basic research institute, with research programs in cancer, neuroscience, genomics and plant biology. Although there is not a hospital or any clinical units directly associated with the on-site research program, our researchers collaborate with numerous clinical partners and conduct work using human samples. The CSHL Director of Research Compliance must be broadly knowledgeable across all relevant research areas and able to directly engage and guide faculty through any and all regulatory needs. Ideally, this will be someone with an advanced degree and academic research experience, as well as proven success in compliance and administration in an academic setting. Specific expertise with human subject related research would be ideal. The staff of the CSHL Research Compliance office is relatively small and trained across multiple regulatory areas and responsibilities, creating a dynamic and highly engaged work environment. The Director of Research Compliance leads this group, and will work closely with the Director of Research Operations, Executive Director of Sponsored Programs, Director of the Animal Facility, General Counsel, Chief Operating Officer, Director of the Cancer Center, and Technology Transfer to ensure adherence to all laws, rules, and requirements governing CSHL’s research.
Maintains current knowledge of all regulatory agencies’ announcements, updates, and policy changes;
Disseminates regulatory changes to the administrative staff, conducts training sessions for the appropriate regulatory committees (IRB, IBC, and IACUC) and implements said policy changes;
Documents and ensures adherence to the NIH Genomic Data Sharing (GDS) and Data Management Policies;
Oversee protocol preparation and submission processes for IRB and committees;
Serve on IRB, IBC and IACUC committees;
Prepares, reviews and submits regulatory agency applications, registrations, reports, and correspondence to ensure accuracy and compliance with regulatory standards;
Manages compliance with federal, state, and CSHL regulations concerning human subjects, animal subjects, and rDNA research;
Reviews research grants, contracts, material transfer agreements, and data use agreements for congruency with approved research protocols;
Serves as the point of contact related to records for federal agencies during audits and inspections;
Conducts or directs the internal investigation and follow-up of identified compliance issues;
Submits comments to HHS with regards to proposed changes to regulations, new policies, and compliance issues that significantly impact CSHL;
Reports violations of compliance or regulatory standards to duly authorized enforcement agencies as appropriate or required.
Education: Masters degree minimum; PhD and/or MD preferred
Experience/Skills: At least 7 years experience in research compliance at a biomedical academic department/institute, ideally with human subject research/IRB. Strong leadership and communication skills; Extensive knowledge of federal rules and regulation related to biomedical research; Broad scientific knowledge in genetics, cancer biology, neuroscience or molecular biology. Ability to work with all levels of CSHL faculty, staff and administrators in a collegial, concise, knowledgeable and customer-service oriented manner
Compensation and Benefits:
Our employees are compensated in many ways for their contributions to our mission, including competitive pay, exceptional health benefits, retirement plans, time off, a range of recognition, access to our Sight MD Wellness Center and an affordable & licensed on-site childcare center. Visit our CSHL Benefits site to learn more. The salary range for this role is $110,000 – $130,000. The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a base salary and/or rate, several factors may be considered as applicable (e.g., years of relevant experience, education, credentials, and internal equity).
Cold Spring Harbor Laboratory is a world-renowned research and education institution recognized internationally for its excellence in fundamental areas, such as cancer, neuroscience, plant biology, genomics, and quantitative biology. The Laboratory has long been recognized as a place for nurturing young scientists, with post-doctoral researchers being an integral part of the discovery process. The Laboratory offers a warm, collegial, and collaborative work environment in a beautiful location about one hour from New York City. For more information about CSHL, please visit us at www.cshl.edu
We strongly encourage you to be vaccinated against COVID 19 however; it is not a requirement for employment
CSHL is an EO/AA Employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status. VEVERRA CONTRACTOR
Application Deadline: 2024-03-11