TRUE NORTH CLINICAL RESEARCH — REGULATORY SPECIALIST
Position Title: Regulatory Specialist
Department: Regulatory
POSITION FUNCTION
The Regulatory Specialist is responsible for ensuring all central study regulatory documents are completed accurately and in a timely manner, ensures compliance with all regional healthcare regulations in research documentation. The Regulatory Specialist must have a strong understanding of the regulations governing clinical trials to be involved in regulatory document preparation and submission before and during a clinical trial. The Regulatory Specialist will act as a direct liaison with the Sponsor, Clinical Research Organization (CRO) and Research Ethics Board (REB) or Institutional Review Board (IRB) to facilitate prompt review and approval of study documents.
ORGANIZATION SUMMARY
ESSENTIAL FUNCTIONS
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Complete Confidentiality Disclosure Agreements.
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Accurately and timely completion of feasibility questionnaires to optimize site selection.
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Complete and submit all regulatory documents in a timely manner unless delegated locally to site to manage.
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Liaise with the Sponsor and Research Ethics Board (REB) or Research Ethics Research Committee (Nova Scotia) to facilitate prompt review and approval of study documents.
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Collaborate with the Recruitment Department for recruit material submissions.
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Responsible for recruitment material submissions and approvals with REBs and IRB.
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Ensure timely study starts and achievement of First Patient First Visit (FPFV).
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Attend and update True North Clinical Research Management team at scheduled meetings and address any regulatory concerns identified.
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Provide support, knowledge, and assistance as needed to any research staff or Sponsor/CRO to help clarify or address any Regulatory questions.
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Assist Clinical Research Coordinators by providing documentation to Sponsors/CROs upon request.
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Ensure pre-Site Visit questionnaire, and medical licenses are available and up to date.
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Communicate all regulatory needs (updated CVs, request IATA and GCP certificates, verify licenses and local lab documentation) to Clinical Research Coordinators in a timely manner, and remind Clinical Research Coordinators of actions to be taken with the documents.
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Maintain central regulatory documents and support long term archiving for all True North Clinical Research sites.
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Serve as the “gatekeeper” for all essential documents which require signatures; disperse documents, submit signed copies to the requestor, hold wet inks, mail originals when requested, and track appropriately.
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Create spreadsheets to track and request regulatory documents prior to expiration.
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Assist Clinical Research Coordinators in clinical trial Continuing Review and Close-out process by completing and submitting documentation to IRB.
EDUCATION/EXPERIENCE
Minimum:
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High School Diploma/GED
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A minimum of 1–2 years of experience in clinical research with strong knowledge of Regulatory best practices
Preferred:
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Bachelor of Science Degree
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1–3 years of experience within True North Clinical Research
CORE COMPETENCIES/SKILLS
Prerequisite (Essential):
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Excellent communication skills (verbal and written)
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Excellent computer skills (MS Word, Excel and Outlook)
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Attention to detail
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Ability to manage time efficiently
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Self-directed
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Teamwork & Collaboration
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Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
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Flexible & Adaptable
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Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines
Foundation:
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Conflict resolution
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Receptive to feedback
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Empowering & Developing others
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Empathy Skills
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Planning and organizing skills
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Excellent problem-solving skills
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Achievement oriented
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Analytical ability
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Initiative
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Decision making
Leadership:
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Forward thinking
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Innovative
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Creative
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Strategic thinking
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Self confidence
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Strong interpersonal skills
PHYSICAL DEMANDS
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Physical demands include but are not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
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Frequently required to complete work on the computer in a seated position.
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May be required to lift light boxes (10–20 lbs).
WORKING CONDITIONS
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Modern medical office environment or home office environment.
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Required to follow CCOHS guidelines, in addition to other local healthcare regulations.
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Required to perform duties in relation to PIPEDA, and other local privacy regulations.
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Some positions may require overnight/weekend hours.
BENEFITS
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Comprehensive health benefits, competitive salary
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RRSP contribution matching
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Continued opportunities for growth & development; yearly education allowance
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Paid holiday closures and employee appreciation days off
The above statements are intended to describe the general nature and level of work being performed by most people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and requirements. Scheduling flexibility may be required to accommodate changing business needs.
