Research Integrity Specialist

Research Integrity Specialist Req ID #:  96816 Location: 

New Haven, CT, US, 06510 For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

  Job Summary Charles River Insourcing Solutions, is seeking a Research Integrity Specialist for their client in New Haven, CT. The candidate will be responsible for coordinating processes for the Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Research-Institutional Review Board (R-IRB), and Research Publications committees. This role will maintain documentation and support workflows within multiple system and applications owned by the client. Records and documentation maintained may be used in submissions to regulatory agencies or in support of attaining accreditation(s), licensure(s), or acceptance of articles to peer reviewed journals. Assignments involve work of an extremely confidential and complex nature.

Review, comprehend and comply with all SOP's and quality assurance standards pertaining to specific area. Review, comprehend and comply with Animal Welfare Act, the “Guide for the Care and Use of Laboratory Animals”, FDA, MHRA, client policies and Guidelines and other applicable regulations and policies.

• Utilize client owned systems and applications to manage SOPs, protocols, amendments, annual reviews, publications submissions, applications by research team members for funding in support of learning & development, and provide other services and support to the client.

• Assist in maintaining the calendars of activities for IACUC, IBC, R-IRB, and Research Publications, including support to client in scheduling Semi-Annual site inspections, and AAALAC inspections.

• Generate semi-annual inspection and program review reports. Assist the IACUC Committee with conducting facility inspections.

• Generate reports, maintain, and monitor licensure and accreditation required by the USDA, OLAW, AAALAC, the FDA and MHRA.

• Review SOPs, protocols, amendments, and annual reviews for missing items.

• Assist in the coordination of IACUC, IBC and R-IRB meetings by: preparing agenda, circulating documentation, assigning primary and secondary reviews of new protocols and amendments, attend committee meetings, take attendance, take meeting notes, write minutes, get minutes approved and signed then forward to appropriate individuals and offices.

• Send approval communication to Principal Investigator (PI) after completion of stipulations mandated by the IACUC, IBC or R-IRB.

• Send reminders and track compliance regarding reviews for Protocols.

• Assist in the development, maintenance, and communication of departmental systems and SOPs.

• Organize, maintain, and protect confidentiality of activities in support of all committees and supported workstreams.

• Perform data entry to include: Word processing (typing minutes, manuscripts, reports), personnel training. Excel – prepare lists and charts of protocols, personnel, animal facilities/labs and supplies.

• Assist with data gathering and completion in preparation of internal or external audits.

• Maintain required attendance level and adherence to work schedule in accordance with required staffing levels to ensure that assigned duties are completed.

• This role may allow for remote working. Attendance and availability during normal working hours (8:30 to 5:00) is expected and required

Job Qualifications QUALIFICATIONS

• Education: Bachelor’s of Science (BS) degree or above in Animal Science or Healthcare Administration or related field.

• Experience: 5 years or more experience working in laboratory research environment supporting scientific research staff and research leadership is required. IACUC, IBC, or IRB experience preferred.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Certification/Licensure: AALAS certification at the Assistant Laboratory Animal Technician level (ALAT) or above preferred.

KNOWLEDGE, SKILLS AND ABILITIES

• Familiarity with AAALAC requirements and “the Guide” is required; experience working in a GxP lab setting is a plus.

• Computer literacy is required. The ideal candidate will have experience with the following: Microsoft Outlook, Word, Excel, Power Point, and Visio. Experience with tick@lab, iEnvision, Smartsheets, SharePoint, and Adobe Acrobat Pro is a plus.

• The ideal candidate will have the ability to meet reasonable deadlines, work independently with minimal supervision, and demonstrate excellent organizational skills- especially time management.

• Must be able to follow verbal and written instructions and exhibit interpersonal skills that are conducive to effective communication and that contribute to a congenial work environment. Maintain positive work atmosphere by behaving and communicating in a professional manner with clients, customers, coworkers, and supervisors.

• Comprehension of veterinary, scientific, and medical terminology preferred.

• Ability to read, write, speak and understand English.

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

About Insourcing Solutions

Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: New Haven

Nearest Secondary Market: Hartford

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