Regulatory and Start Up Specialist

5 months ago


Remote, Canada Precision Medicine Group Full time

**Position** **Summary**:
The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.

**Essential** **functions** **of** **the** **job** **include** **but** **are** **not** **limited** to**:

- Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
- Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
- Prepare. review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
- Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
- Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
- Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
- When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
- May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
- Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
- May support the clinical team performing Pre-Study Site Visits.
- May support process improvement initiatives, training, and mentoring.
- Performs other duties as assigned by management.

**Qualifications**:
**Minimum Required**:

- Bachelor's degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies

**Other** **Required**:

- Strong communication and organizational skills are essential.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English and for non-English speaking countries the local language of country where position based.

**Preferred**:

- Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
- Exper



  • Remote, Canada Alimentiv Full time

    Support Project Management, Regulatory, and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare, distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and...

  • Junior Ghs

    5 months ago


    Remote, Canada ERA Environmental Management Solutions Full time

    ERA-EHS is a world-leading developer of Environmental, Health and Safety (EHS) software for manufacturers across a broad range of industries, particularly the automotive, chemical, and petroleum sectors. We invent and develop software solutions to help manufacturers across the world track, report, and reduce their environmental footprint. Our base of...

  • Financial Specialist

    5 months ago


    Remote, Canada Home and Community Care Support Services Full time

    _CARE AND BE CARED FOR - THIS IS YOUR HOME_ Are you an experienced Financial Specialist that enjoys creation, analysis and accurate processing of financial and statistical reporting? Are you seeking a financial profession within the healthcare sector? **If so, take a look at this rewarding career opportunity working alongside a supportive and collaborative...

  • Payroll Specialist

    5 months ago


    Remote, Canada Diabetes Canada Full time

    A world free of the effects of diabetes is our vision. That’s why we’re working together to improve the quality of life of people living with diabetes. We’re sharing knowledge and creating connections for individuals and the health-care professionals who care for them; advocating through public policy; and funding research to improve treatments and...


  • Remote, Canada Payactiv Full time

    **Position: Client Onboarding Specialist** **Company info: Payactiv** **Has Contact with**: Customers, Sales & Marketing teams, Customer Support, Management **Estimated Start Date**:ASAP **Work Location**: Remote (GTA location preferred) **Job Type**: Full-Time **Compensation**:Competitive package **Group Benefits**: Yes **Education**:A bachelor’s...


  • Remote, Canada National Nursing Assessment Service Full time

    **About National Nursing Assessment Service** The National Nursing Assessment Service (NNAS) is a Canadian not-for-profit organization that provides credentialing services to assess Internationally Educated Nurses’ (IENs) education and professional experience to inform the licensing decisions made by provincial nursing regulatory bodies. With nearly 10...

  • Country Trials Manager

    5 months ago


    Remote, Canada Parexel Full time

    Canada, Remote Canada **Job ID** R0000012476 **Category** Clinical Trials **ABOUT THIS ROLE**: **Accountability** **Activities** may include but are not limited to the following **SSU Country** **Level Delivery** - ________________ - Oversees the execution of: - Country level implementation of Start Up and Site Activation Plans - Country level...


  • Remote, Canada Tali AI Full time

    Tali AI is dedicated to tackling the issue of physician burnout through the development of a voice-enabled virtual assistant designed specifically for physicians. This innovative assistant streamlines their professional lives by significantly minimizing the time spent on documentation and administrative tasks. We are a results-focused and data-driven...


  • Remote, Canada J. J. Keller & Associates, Inc. Full time

    It's an exciting time at J. J. Keller as we continue to **grow and expand our vehicle service offerings in Canada**. In an effort to support our growth, we are hiring for a Client Service Specialist. This is an **advisory role that manages an assigned client base ensuring the client's needs are met** in an efficient and effective manner. This role will...


  • Remote, Canada H&R Block Canada Full time

    **Canada (Remote)**: **Field Technical Support Specialist** For over 60 years, H&R Block has prepared taxes for millions of Canadians annually. Headquartered in Calgary, Alberta, we serve taxpayers in more than 1,000+ offices, through our upload from home service, and online with our DIY tax software. Our dedicated team of Tax Experts use the latest in...

  • Front/back Sales

    5 months ago


    Remote, Canada UP SPEED FINANCE Full time

    UpSpeed Finance is one of the few financing platforms in Canada with access to over 19 financial institutions for Auto, Leisure, Marine & Recreational vehicles, and we are currently looking to expand our team in the region. As a Finance Manager, you will play a pivotal role in our dealership by managing the financing process from start to finish. You will...

  • SEO Specialist

    5 months ago


    Remote, Canada All The Way Up Media Full time

    **Job description** **Duties** Execute project tasks according to timelines and priorities; Help to manage and develop relationships with stakeholders and client reps Help with identifying and scoping new projects Prepare performance reports; analyze campaigns and website performance data using marketing reporting tools such as Google Analytics, Google...


  • Remote, Canada Newfold Digital Full time

    Who we are. - Awesome opportunity for you to start a career in technology! We are looking for a passionate, tech-savvy, problem-solving, and customer service-focused individual to join our Modifications Call Center Specialist team. We will train you to become a website guru who will consult with and assist customers through utilizing your creativity and...


  • Remote, Canada WalletCard Full time

    **_Seeking Passionate Sales Operations Specialist for Vancouver SaaS Startup!_** We’re hiring! WalletCard is a Vancouver based software company transforming blue-collar health & safety certification management from paper-based manual processes to an easy-to-use streamlined system. **Responsibilities** Because we’re a distributed team this means...


  • Remote, Canada ProPet Software Inc. Full time

    ProPet Software Inc. is a start-up that is focused on delivering comprehensive SaaS-based management software for the professional pet care industry. We are looking for a Full-Time Customer Success Specialist to join our team and share in the growth of ProPet as we strive to become the global market leader in the pet care business software space. ProPet is...


  • Remote, Canada Precision Medicine Group Full time

    **Position Summary**: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going...

  • On Page SEO Specialist

    6 months ago


    Remote, Canada Inspira Education Group Full time

    We are currently seeking a highly motivated and detail-oriented **Part-Time On Page SEO Specialist **to join our team for up to **20/hours a week**. As an On Page SEO Specialist, you will play a vital role in optimizing our website's visibility and increasing organic search rankings. You will work closely with the SEO team and collaborate with other...


  • Remote, Canada IQVIA Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Credit Manager

    5 months ago


    Remote, Canada Strive Capital Corporation Full time

    **Company description** Strive was founded in 2020 and has since grown to a team of 70+ industry leaders with many years of experience. We are located in the heart of Toronto, at 110 Yonge Street, Suite 1704. At Strive, our entire team exhibits excellent accountability, collaboration, and clear communication, and takes a hands-on approach of support and...


  • Remote, Canada Fitness Machine Technicians Full time

    **Customer Experience Specialist / Scheduler - Fitness Equipment** Fitness Machine Technicians Alberta is looking for a Customer Experience Specialist / Scheduler who can hit the ground running, provide all around customer service support and dispatch scheduling to the team. **Who we are?** - Fitness Machine Technicians is the fastest growing fitness...