Compliance Specialist Human Biological Samples Mississauga - Hybrid IntroductionThe Compliance Specialist will coordinate projects and assist in their execution, ensuring the collection and organization of all information related to Human Biological Samples (HBS). The role may involve working within the Biobank to reconcile the HBS inventory or curating data to facilitate informed decision-making regarding the inventory. Additionally, the Compliance Specialist will review consent forms for compliance and collaborate with stakeholders to ensure the ethical and compliant use of donated samples.ResponsibilitiesCollaborate with internal teams in locating documentation and reviewing consent related to HBS.Assist the Biobank lead and team in linking samples to consent forms. Duties may include handling of HBS during the reconciliation and curation process.Work with Biobank leads to ensure that learning from HBS related issues are identified and analysed to enable continuous process improvement.Review consent forms for use restriction & storage information. Electronically manage HBS retrievals, including receipt, tracking, review and approval of requests from internal requestors. Confirm requests against the informed consent, raise requests as the need arises.Ensure sample manifests are completed to document the HBS transport or receipt.Assist the Biobank lead in identifying & managing sample sharing between teams.Work with the Biobanks to optimise processes around Biobank requirements for compliance.Work with various Biobanks to ensure sample compliance.Participate & contribute to team meeting & discussions.Support team members in delivering the Departmental goals.Assist in knowledge curation to allow decision making on inventory which maybe in-house, or third parties.Assist with the resolution of issue and queries relating to HBS within the inventory. Maintain records for HBS stored until it meets final disposal and follow destruction process when initiated.RequirementsBachelors degree level education or higher.5 + years experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS.6 months+ of experience relevant work experience to this role.Excellent analytical, written and oral communications skills.Project management experience and skills.High ethical standards, willingness to challenge inappropriate proposals/actions.Strong collaborative, partnering, and interpersonal skills.Desired ExperienceKnowledge and understanding of compliance function, health care regulations, laws and standards.Direct experience of working with Human Biological Samples.Previous experience as a process owner and process improvement.Experience in collection and use of HBS as part of ongoing clinical trials.What We OfferWhy apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. Well get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. Thats what we continually strive for. Over 45 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.
Job Title
Compliance Specialist – Human Biological Samples