- Investigate, review and report compliance concerns and reported events
- Oversee all activities related to the PAM program including
- 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 reports
- 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 events
- 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 members
-
Compliance Specialist
2 weeks ago
Alphanumeric Systems Cambridge, United StatesAlphanumeric is hiring a Quality Systems Specialist to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · POSITION TITLE: Quality Systems Specialist · ON SITE - 9am-5pm / Monday - Friday · PAY - $52.35 ...
-
Compliance Specialist
3 weeks ago
Alphanumeric Systems Cambridge, United StatesAlphanumeric is hiring a COMPLIANCE SPECIALIST to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · We have an exciting new opportunity for an experienced Compliance Specialist who will work closely w ...
-
Compliance Specialist
3 weeks ago
Randstad North America, Inc. Cambridge, United StatesExciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing complian Compliance Specialist, Compli ...
-
Compliance Specialist
2 weeks ago
LanceSoft Cambridge, United StatesPOSITION TITLE: Quality Systems Specialist · ON SITE - 9am-5pm / Monday - Friday · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with *** policies, QM ...
-
Compliance and Credentialing Specialist
2 weeks ago
Boston Public Health Commission Boston, United StatesJob Description · The mission of the Boston Public Health Commission (BPHC) is to work in partnership with communities to protect and promote the health and well-being of all Boston residents, especially those impacted by racism and systemic inequities. The BPHC envisions a thri ...
-
Retail Compliance Specialist
2 weeks ago
C3 Industries Boston, United StatesJOB SUMMARY: · The Retail Compliance Specialist is responsible for ensuring that assigned retail stores are operating in compliance with state and local ordinances, rules and regulations. · JOB DUTIES: · Core duties and responsibilities include the following. Other duties may be ...
-
Manufacturing Compliance Specialist
1 week ago
The Accuro Group Cambridge, United StatesBusiness Title: | Manufacturing Compliance Specialist · Location: Cambridge, MA 02142 · Job Type: Contract (12 Months) · Note: Parking will not be reimbursed by the CLIENT. Parking is roughly $420/mo. · Important: MFG background is mandatory. · Job Description: · THE CLIENT is a ...
-
Engineering Compliance Specialist
1 week ago
Manpower Engineering San Francisco, United States TemporaryOur client, in the Biopharma industry is seeking an Engineering Compliance Specialist to join their team. As a Compliance Specialist, you will be part of the Engineering team supporting Compliance.The ideal candidate will have an Engineering background, experience generating FMEA ...
-
Engineering Compliance Specialist
1 week ago
Manpower Engineering Cambridge, United States TemporaryOur client, in the Biopharma industry is seeking an Engineering Compliance Specialist to join their team. As a Compliance Specialist, you will be part of the Engineering team supporting Compliance.The ideal candidate will have an Engineering background, experience generating FMEA ...
-
Compliance Specialist I
3 weeks ago
LexisNexis Risk Solutions Cambridge, United StatesAbout the Business · LexisNexis Risk Solutions is the essential partner in the assessment of risk. Within our Business Services vertical, we offer a multitude of solutions focused on helping businesses of all sizes drive higher revenue growth, maximize operational efficiencies, a ...
-
cGMP Compliance Specialist
1 week ago
Yoh Cambridge, United StatescGMP Compliance Specialist – 2nd shift needed for a contract opportunity with Yoh Scientific's client located in Cambridge, MA. · This position is for a pharmaceutical company and is suitable for someone with a working knowledge of cGMPs and associated regulatory requirements fo ...
-
Compliance Specialist I
4 days ago
RELX Group Cambridge, United StatesAbout the Business · LexisNexis Risk Solutions is the essential partner in the assessment of risk. Within our Business Services vertical, we offer a multitude of solutions focused on helping businesses of all sizes drive higher revenue growth, maximize operational efficiencies, a ...
-
Compliance Specialist
3 weeks ago
Randstad North America, Inc. Cambridge, United StatesAs a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report Compliance Specialist, Compli ...
-
Compliance specialist
2 weeks ago
Randstad Cambridge, United Statesjob summary: · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report to the QMS Man ...
-
IACUC Regulatory Compliance Specialist
1 week ago
Massachusetts General Hospital(MGH) Charlestown, United StatesGENERAL 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 ...
-
Mass General Brigham Somerville, United States RegularHuman Research Compliance and Auditing Specialist Description Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and ...
-
Engineering (EHS) Compliance Specialist
14 hours ago
The Accuro Group Cambridge, United StatesBusiness Title: | Engineering Compliance Specialist · Location: Cambridge, MA 02142 · Job Type: Contract (3 M+) · Note: Parking will not be reimbursed by the CLIENT. Nearby garage parking is available for roughly $420/month. · Job Description: · This role will support the enginee ...
-
Mass General Brigham Somerville, United StatesCome join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality As ...
-
Quality & Compliance Specialist
3 weeks ago
Mass General Brigham Charlestown, United StatesSafety occurrence reporting system and investigations related to adverse events are managed in accordance with department and regulatory guidelines. Patient Satisfaction Program is implemented and monitored to achieve stated goals. Performance improv Compliance Specialist, Compli ...
-
Partners Healthcare System Somerville, United StatesCome join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality Ass ...
IACUC Regulatory Compliance Specialist - Charlestown, United States - Partners Healthcare System
Description
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.
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:
o Record IACUC deliberations and determinations. Communicate results to appropriate parties
o Ensure corrective actions plans are implemented by research teams and other parties, alerting the Director and IACUC for support, as needed
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
o Review annual reports, facility access requests and staff amendments
o 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
o 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 indicated
o Review and update of IACUC policies
o Program inspections (USDA, AAALAC, Cambridge commissioner, others)
o Preparation of annual reports and assurance letters to regulatory and accreditation agencies
o Other compliance monitoring including but not limited to: monthly census check, animals transfers, holding protocol, found dead animals (USDA species only), PAM Audits
o Defining the specifications for and maintenance of reports from Insight-Microstrategy
o 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
o Participate in process improvement initiatives
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
o Extensive knowledge of animal welfare regulations and IACUC best practices
o Excellent oral and written communication skills
o 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 preferred
EDUCATION:
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.
&v=024){kind=logo}
