Regulatory Specialist

NUVISTA Mental Health•Halifax, NS

1d•CA$70,000 - CA$80,000•Hybrid

About The Position

The Regulatory Specialist is responsible for ensuring all central study regulatory documents are completed accurately and in a timely manner, and 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.

Requirements

High School Diploma/GED
A minimum of 1–2 years of experience in clinical research with strong knowledge of Regulatory best practices
Excellent communication skills (verbal and written)
Excellent computer skills (MS Word, Excel and Outlook)
Attention to detail
Ability to manage time efficiently
Self-directed
Teamwork & Collaboration
Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
Flexible & Adaptable
Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Nice To Haves

Bachelor of Science Degree
1–3 years of experience within True North Clinical Research

Responsibilities

Complete Confidentiality Disclosure Agreements.
Accurately and timely completion of feasibility questionnaires to optimize site selection.
Complete and submit all regulatory documents in a timely manner unless delegated locally to site to manage.
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.
Collaborate with the Recruitment Department for recruit material submissions.
Responsible for recruitment material submissions and approvals with REBs and IRB.
Ensure timely study starts and achievement of First Patient First Visit (FPFV).
Attend and update True North Clinical Research Management team at scheduled meetings and address any regulatory concerns identified.
Provide support, knowledge, and assistance as needed to any research staff or Sponsor/CRO to help clarify or address any Regulatory questions.
Assist Clinical Research Coordinators by providing documentation to Sponsors/CROs upon request.
Ensure pre-Site Visit questionnaire, and medical licenses are available and up to date.
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.
Maintain central regulatory documents and support long term archiving for all True North Clinical Research sites.
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.
Create spreadsheets to track and request regulatory documents prior to expiration.
Assist Clinical Research Coordinators in clinical trial Continuing Review and Close-out process by completing and submitting documentation to IRB.