Study Start-up Specialist

7 days ago

Vaughan, Ontario, Canada SRx Health Solutions company Full time
_Do you want to work with a collaborative, diverse team and gain innovative experience in one of the fastest evolving industries? _

SRx health solutions is a fast-growing healthcare solutions services company designed for today's growing markets. We are Canada's leading healthcare provider and have grown with over 400 employees across the country. We provide innovative, sustainable, and integrated healthcare solutions with a mission to enhance the wellness of Canadians.

You will be part of a team that is dedicated to create immersive experiences and transforming ideas into successful health care programs that matter.

Here, you will be empowered to follow your passion to continuously learn and grow. Not to forget to mention, we have one of the friendliest teams on the globe

What you will be doing:

Support Business Development and Operations in all site-related pre-launch start-up activities. Establish relationships with study personnel at Sponsor/CRO and act as main contact during study pre-launch.

Plan and track site start up activities and data using designated systems and tools. Provide reports on intelligence and metrics related to study start-up activities.

Site Feasibility:

Supports assessment of new clinical research trials; accurately completing site feasibility surveys

Works with management to determine, site and PI assignment

Coordinates site qualification meetings

Site Contract and Budget Negotiation:

Act as main point of contact on budget and contract negotiations.


In co-operation with Legal counsel, obtain feedback on suggested site and investigator contract language applicable to Confidentiality Disclosure Agreements/Clinical Trials Agreements etc.

Effectively build protocol specific study budgets based on existing templates and fees

Responsible for obtaining signatures from authorized signatories on all final approved budgets and contracts

In conjunction with the management, provide Sponsor/CRO with the suggested study budget and negotiate accordingly.

Prepare 3rd party vendor contracts (as needed) using existing agreement templates/support from Legal

Responsible for processing any amended contracts/budgets as a result of protocol changes

Incorporate budget into sites payment tracking platform (CRIO)

Site Start-Up Planning and Tracking & Project Management support:
Initiate introductions to key study team contacts on execution of contracts


Maintain site tracker with data related to specific requirements for study sites such as start-up timelines, budget, contract negotiation timelines and prerequisites, patient recruitment data, etc.


In conjunction with Clinical Site Manager & Clinical Operations Associate, plan start-up actions and provide expected SIV dates based on previous start-up metrics, as well as regulatory and /RB timelines.

Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentations.

Provide support to project management with study related activities as required.

Physician Onboarding:


Supports Business Development in onboarding of new physicians interested in joining TDDA's research network; prepare and distribute NDAs, Investigator Agreements etc.


Your Qualifications:

  • Applicants should have a minimum of three years of related work experience in Clinical Research.
  • Experience in working directly with clinical study sites/ pharmaceutical partners through previous involvement in studies.
  • Can effectively multitask and prioritize based on urgency.

KPIs:

  • Pitch feasibility
- negotiate and execute on 12+ contracts/year under the SMO group

  • Support evaluations of +1 new site partner
  • Support Onboarding of +5 new Physicians as part of TDDA's Network

Why you should work with us?

  • Paid vacation
  • Paid sick days
  • Bonus
  • RRSP Matching
  • Comprehensive salary
  • Benefits package
  • Opportunities to develop new skills and progress your career
-
If it sounds like you, we want you to apply_

About us:

SRx Health Solutions was founded in 2013 by its current President, Adesh Vora. After running retail pharmacies for over 12 years, Mr. Vora opened two pharmacies in Ontario. To achieve this, Mr. Vora recognized the need to provide more than just retail pharmacy services.

Our company fosters a collaborative and inclusive work environment that empowers individuals to thrive, embrace challenges, and make a meaningful impact on the healthcare industry.


Job Types:
Full-time, Permanent

Pay:
From $75,000.00 per year

Benefits:

  • Dental care
  • Extended health care
  • Flexible schedule
  • Life insurance
  • Paid time off
  • RRSP match
  • Vision care

Flexible Language Requirement:

  • French not required

Schedule:

  • Monday to Friday

Supplemental pay types:

  • Bonus
pay

Ability to commute/relocate:

  • Vaughan, ON L4L 4Y7: reliably commute or plan to relocate before starting work (required)

Experience:

  • Budgeting: 1 year (required)
  • Clinical Researc

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