IACUC Regulatory Compliance Specialist

2 weeks ago

Boston, United States Partners Healthcare System Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Leads the investigation, review and reporting of potential compliance concerns and adverse events. Manages the post-approval monitoring program to promote and assess compliance with approved IACUC protocols and institutional policies and standards. Oversees and coordinates the IACUC semiannual program review and facility inspection. Completes and submits all required Federal and State reports and acts as a liaison for all regulatory inspections. Develops and maintains IACUC protocol review processes and procedures that are consistent with applicable state and federal regulations and institutional policies. Serves as program manager for the AAALACi site visit and ensures the program meets the accreditation standards for IACUCs.PRINCIPAL DUTIES AND RESPONSIBILITIES:* Investigate, review and report compliance concerns and reported eventso Receive all reported incidents and events; review for merit and conduct investigation with appropriate stakeholders; Prepare reports for review by the IACUC Compliance Subcommittee and final determination by the IACUCo Record IACUC deliberations and determinations. Communicate results to appropriate partieso Ensure corrective actions plans are implemented by research teams and other parties, alerting the Director and IACUC for support, as neededo Identify and tabulate trends for IACUC review; identify, communicate and participate in opportunities for continuous improvement in IACUC processes and the animal care and use program* Oversee all activities related to the PAM program includingo Schedule, coordinate and participate in, document, and ensure follow-up on all PAM activitieso Review annual reports, facility access requests and staff amendmentso Oversee and coordinate the IACUC semiannual program review and facility inspection. Schedule the inspection of all animal housing and use areas involving the committee members, consultants and the entire animal research community. Manage the semiannual program review. Document and present findings to the Committee. Prepare the report to the Institutional official. Ensure all findings and deficiencies have a corrective action plan and timeline for correction that is communicated to stakeholders in a timely manner. Document implementation of all corrective actions.o Identify and tabulate trends for IACUC review; identify, communicate and participate in opportunities for continuous improvement in IACUC processes and the animal care and use program* Complete and submit all required Federal and State reports and acts as a liaison for all regulatory inspections, including all reports to USDA APHIS, NIH OLAW, AAALACi, MDPH and the City of Cambridge.* Assist investigators in understanding IACUC expectations for research using laboratory animals;* Participate in the interpretation of animal welfare regulations to define IACUC policies, practices and procedures.* Leads the investigation, review, and reporting* Ensures all Federal and State reporting requirements are met, developing systems and procedures, and collecting the data necessary to ensure reports are accurate and timely.* Monitor laboratory animal research activities to determine adherence to and compliance with institutional policies and applicable state and federal regulations by active participation in the following:o Review of IACUC protocols, amendments, annual reportso Prepare and submit semi-annual inspection and program evaluation reports to the IACUC and IOo Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicatedo Review and update of IACUC policieso Program inspections (USDA, AAALAC, Cambridge commissioner, others)o Preparation of annual reports and assurance letters to regulatory and accreditation agencieso Other compliance monitoring including but not limited to: monthly census check, animals transfers, holding protocol, found dead animals (USDA species only), PAM Audits* Develop forms and tools to enhance documentation of research activities and animal health monitoring to assure compliance with applicable USDA and PHS regulations, policies and guidelines including but not limited to:o Tracking of facility inspections/audits/deficiencies/reportable eventso Continuous enhancement of the eIACUC application formso Defining the specifications for and maintenance of reports from Insight-Microstrategyo Data update / data curation including: researcher's qualifications and experience; orientation/training attendance; OHS clearance; Other training (Cage side NHP training, CITI)o Update and maintain IACUC internal website* Identification and implementation of methods or tools for training and education of researchers and IACUC members* Remain up-to-date on Federal and State regulations pertaining to laboratory animal care* Other responsibilities as needed including:o Serve as back-up for other office staff memberso Serve as IACUC representative on program-related meetings inside and outside the organizationo Participate in process improvement initiativesSKILLS/ABILITIES/COMPETENCIES REQUIRED:o Extensive knowledge of animal welfare regulations and IACUC best practiceso Excellent oral and written communication skillso Excellent organizational skills. Ability to manage to timelines and targets in administrative improvements. Capable of working independently.o Excellent interpersonal skills. This position involves interacting with employees, customers, consultants and vendors at all levels of the organization and with very diverse backgrounds.o Has a customer-focused attitude and enjoys working with similarly dedicated persons in a team fashion within a high-energy research environment.LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable):CPIA preferred. Additional certifications such as ACLAM or AALAS or equivalent preferredEDUCATION:Bachelor's degree in related field required; Master's degree preferred.EXPERIENCE:5-10 years of experience required with a minimum of 3-5 years IACUC experience required.WORKING CONDITIONS:Standard office environment and onsite monitoring in animals holding areas and research laboratories. This is a hybrid position with a minimum expectation of 3 days on-site (preferably 4 days on-site) and 1 day remote.#J-18808-Ljbffr

by Jobble

  • IACUC Regulatory Compliance Specialist

    2 weeks ago

    Boston, United States Massachusetts General Hospital Full time

    Job Description - IACUC Regulatory Compliance Specialist (3271795) IACUC Regulatory Compliance Specialist - ( 3271795 ) The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office.Leads the...

  • IACUC Regulatory Compliance Specialist

    4 weeks ago

    Boston, United States Massachusetts General Hospital Full time

    Job Description - IACUC Regulatory Compliance Specialist (3271795) IACUC Regulatory Compliance Specialist - ( 3271795 ) The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office.Leads the investigation,...

  • Product Stewardship Regulatory Compliance Specialist

    4 weeks ago

    Boston, United States Gradient Full time

    Job Description Gradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients by applying knowledge of US and international regulatory compliance for product stewardship. Responsibilities include providing regulatory interpretation and guidance, evaluating GHS hazards, reviewing safety data sheets (SDSs) and...

  • Product Stewardship Regulatory Compliance Specialist

    1 month ago

    Boston, United States Gradient Full time

    Job DescriptionJob DescriptionGradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients by applying knowledge of US and international regulatory compliance for product stewardship. Responsibilities include providing regulatory interpretation and guidance, evaluating GHS hazards, reviewing safety data...

  • Compliance Specialist

    3 weeks ago

    Boston, United States Storm2 Full time

    Role: Compliance Specialist Industry: InvestTech Location: Boston, hybrid Storm2 are partnered with a VC backed InvestTech with huge potential. My client are looking for an experienced marketing compliance specialist ready to take on the essential role of optimizing the effectiveness and efficiency of the content marketing team. In this role you will...

  • Regulatory Compliance Analyst

    2 days ago

    Boston, United States WEX Full time

    WEX Inc. (NYSE:WEX) is a leading provider of business-to-business physical, digital, and virtual card payment solutions. WEX's fleet, corporate, and health payment solutions provide its customers - comprising small businesses, large fleets, and corpo Compliance Analyst, Regulatory, Compliance, Analyst, Business, Payment, Technology

  • Accreditation and Regulatory Specialist

    2 weeks ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY: Under the direction of the Senior Director, Accreditation & Regulatory and working collaboratively, the Accreditation and Regulatory Specialist (Nurse) leads efforts to ensure continual organizational compliance and ongoing readiness with clinical quality and patient safety standards and regulations required by The Joint Commission,...

  • Compliance Specialist

    1 month ago

    Boston, United States Storm2 Full time

    Role: Compliance SpecialistIndustry: InvestTechLocation: Boston, hybridStorm2 are partnered with a VC backed InvestTech with huge potential. My client are looking for an experienced marketing compliance specialist ready to take on the essential role of optimizing the effectiveness and efficiency of the content marketing team.In this role you will report...

  • Compliance Specialist

    4 weeks ago

    Boston, United States Storm2 Full time

    Role: Compliance SpecialistIndustry: InvestTechLocation: Boston, hybridStorm2 are partnered with a VC backed InvestTech with huge potential. My client are looking for an experienced marketing compliance specialist ready to take on the essential role of optimizing the effectiveness and efficiency of the content marketing team.In this role you will report...

  • Compliance Specialist

    4 weeks ago

    Boston, United States Storm2 Full time

    Role: Compliance SpecialistIndustry: InvestTechLocation: Boston, hybridStorm2 are partnered with a VC backed InvestTech with huge potential. My client are looking for an experienced marketing compliance specialist ready to take on the essential role of optimizing the effectiveness and efficiency of the content marketing team.In this role you will report...

  • Compliance Specialist

    1 week ago

    Boston, United States Ceres Group Full time

    Responsible for providing the independent monitoring of investment compliance requirements so as to ensure the firms ongoing compliance; advise key business units in related regulatory and client compliance requirements; train investment compliance professionals and key business stakeholders on regulatory and client requirements; and support the management...

  • Principal Regulatory Affairs Specialist

    4 days ago

    Boston, United States BRIOHEALTH SOLUTIONS INC Full time

    Job DescriptionJob DescriptionPrincipal Regulatory Affairs SpecialistJob DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class III...

  • Regulatory Affairs Specialist

    5 days ago

    Boston, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineering, Law, Customer Energy Solutions, Corporate Accounting and IT, and other...

  • Compliance Specialist I

    4 weeks ago

    Boston, United States PSG Global Solutions Full time

    Description We're looking for a Compliance Specialist I , working in Pharmaceuticals and Medical Products industry in 500 Soldiers Field Road, Boston, Massachusetts, 02134, United States . Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Conducts internal audits...

  • Principal Regulatory Specialist

    4 days ago

    Boston, United States Amplitude Vascular Systems Full time

    Duties and Responsibilities: Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing. Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports....

  • IT Compliance

    2 weeks ago

    Boston, United States Delphi-US Full time

    Title: IT Compliance & Risk Management Specialist (Contract) - Job#4937Location: Boston, MA/Hybrid remote Job Description: Our client a leading Financial Institution located in the Boston, MA has an immediate opening for an IT Compliance & Risk Management Specialist to join their team in a hybrid remote capacity. The IT Compliance & Risk Management...

  • IT Compliance

    4 days ago

    Boston, United States Delphi-US Full time

    Title: IT Compliance & Risk Management Specialist (Contract) - Job#4937Location: Boston, MA/Hybrid remote Job Description: Our client a leading Financial Institution located in the Boston, MA has an immediate opening for an IT Compliance & Risk Management Specialist to join their team in a hybrid remote capacity. The IT Compliance & Risk Management...

  • Principal Regulatory Specialist

    6 days ago

    Boston, United States Amplitude Vascular Systems Full time

    Duties and Responsibilities:Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and...

  • Principal Regulatory Specialist

    2 days ago

    Boston, United States Amplitude Vascular Systems Full time

    Duties and Responsibilities:Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and...

  • Regulatory Affairs Associate

    2 weeks ago

    Boston, United States INTELLECTT INC Full time

    Role: Regulatory Affairs Associate Location: Remote Duration: 7 Months Main Responsibilities Provide regulatory input to product lifecycle planning. Assist in SOP development and review. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand and investigate regulatory history/background of...