Reg & Start Up Spec

6 days ago

St Leonards, Australia IQVIA Full time

Regulatory and Start Up Specialist

We are currently looking for Regulatory and Start Up Specialists to join one of our FSP models. You will manage and execute the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.

**Responsibilities include**:

- Perform Study Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites in Australia and New Zealand.
- Prepare / review ethics and regulatory documentation, reviewing for completeness and accuracy.
- Review, prepare and negotiate site contracts and budgets with sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Ensure all relevant documentation and approvals are in place to authorize Investigational Product release.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure overall project efficiency, quality and adherence to project timelines.

**Skills and experience required**:

- Bachelor’s Degree in Life Sciences or equivalent work experience is required
- 2 - 3 years’ experience Clinical Research or Site Start-Up within a CRO/Pharmaceutical Company, ideally in Australia/New Zealand is required
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills with ability to challenge, if applicable
- Effective communication, organizational, and interpersonal skills

  • Site Activation Specialist

    2 weeks ago

    St Leonards, Australia IQVIA Full time

    We are currently looking for a **Site Activation Specialist **on a full time permanent position. In this role, you will serve as the Single Point of Contact (SPOC) in assigned studies, acting as the main liaison between investigative sites, Site Activation Manager (SAM), Project Management team, managing and executing start up and site activation activities,...

  • Dental Assistant Government Contract

    2 days ago

    St Leonards, Australia AB Dental Employment Agency Full time

    **We have a 2 month contract at Royal North Shore Hospital starting asap. The role is full time Mon-Fri 8-4.30.**: Dental AssistantSt Leonards We have a 2 month contract at Royal North Shore Hospital starting asap. The role is full time Mon-Fri 8-4.30. To be successful you must: - Hold a current Certificate III in Dental Assisting - Have a minimum 2 years...

  • Site Activation Specialist

    2 weeks ago

    St Leonards, Australia Novasyte Full time

    We are currently looking for a Site Activation Specialist on a full time 12 month fixed term contract. In this role, you will serve as the Single Point of Contact (SPOC) in assigned studies, acting as the main liaison between investigative sites, Site Activation Manager (SAM), Project Management team, managing and executing start up and site activation...

  • Wanted Skilled Housekeepers St Leonards, Sydney

    2 weeks ago

    St Leonards, Australia Get You Full time

    **WANTED | Skilled Housekeepers | St Leonards, Sydney** We’re hiring an experienced Housekeeper for a private home in **St Leonards, Sydney** up to 20 permanent hours weekly (Monday - Friday) Work with the same client each week Ideal for those with residential or hotel housekeeping experience - ** Long-Term Opportunities**: Enjoy stable, ongoing casual...

  • Carpentry , Cert Iii

    1 week ago

    St. Georges Basin, Australia 1300 Apprentice Full time

    1300apprentice currently have a fantastic opportunity for an individual to continue or start their Carpentry Apprenticeship with our host partner located in the South Cost. This highly regarded local company is renowned for the quality of work and service, no job to big or to small. **Some of what you will be doing**: - Complete high spec projects -...

  • School Drop Off and Pickup

    5 days ago

    St Leonards, Australia We Need a Nanny Full time

    **Job Description**: **Our Family**: - 28th August start, flexible hours, can accommodate your preferences. Hi there, we have 2 daughters, aged 6, 9 6 year old in local Kindergarten 9 year old in local primary school We leave for work by 7am and return after 6pm Home is 5 minutes walk from St Leonards station Car not essential Walk to kindy/school about 10...

  • Hospital Ward Delivery

    6 days ago

    St Leonards, Australia Momentum Consulting Group Pty Ltd Full time

    We are currently seeking a ward delivery person for our client who is a leading pharmaceutical company, located in St Leonards/North Sydney. - This role requires packing and delivery of pharmaceutical products throughout two leading hospitals. You will be responsible for their stock control. - This role requires continuous lifting, packing and delivering...

  • Membership Sales Consultant

    2 weeks ago

    St Leonards, Australia Virgin Active Full time

    Join an iconic brand and inspire people to live an active life at Bligh St - Base salary + uncapped commission (guaranteed commission for your first 3 months) - Mon-Fri, free gym membership, exclusive PT rates, discounts with retailers There's never been a better time to join Virgin Active, we have the best talent, doing the best work of their lives with...

  • Concierge/receptionist - Part Time

    1 week ago

    St Leonards, Australia Ashdown Consulting Full time

    $31 - $38 p/h + Super - 8 Month Contract - PART TIME - St Leonards **Concierge / Receptionist | 8 Month Contract | $41.99 p/h inc. Super** - $31 - $38 p/h + Super - 8 Month Contract - PART TIME - St Leonards **About the Company** This NSW Government agency is a major service provider who strives to deliver a more consistent and efficient experience within...

  • Sales Assistant

    2 weeks ago

    St Leonards, Australia Bakers Delight Full time

    Sales Assistant required for a busy bakery, early morning start, preffered local person living nearby. **Job Types**: Full-time, Part-time, Permanent, Casual Part-time hours: 20-40 per week **Salary**: Up to $24.00 per hour **Benefits**: - Employee mentoring program Schedule: - 8 hour shift - Afternoon shift - Evening shift - Flexible hours - Morning...