Study Start-Up Specialist Job Openings by Alimentiv in Toronto

Job Title Study Start-Up Specialist
Pub Date 30+ days ago
Company Alimentiv
Location Toronto

Alimentiv Recruitment 2021 - Alimentiv assign a chance to apply Study Start-Up Specialist, that will be placed in Toronto. You will definitely get a better prospect along with less dangerous life sometime soon. Joining to this corporation makes anyone can meet the aim simpler in supplementary to assist the current dream be realized.

To help the business vision and mission comes on right Alimentiv will be wide open up for brand-new place as March 2021. All people who are considering answering this vacant, you need to take a part in this Study Start-Up Specialist recruitment. If you will be the one which might fill up qualifications, you can attempt to learn further info about Study Start-Up Specialist Job Openings below.

Alimentiv Recruitment 2021

Study Start-Up Specialist Job Opening in Toronto

Position Location: US or Canada (home-based)


Position Title: Study Start-Up Specialist (Full-time/Permanent)


Position Reports to: Project Director


Department/Unit Name: Full Service-Clinical Project Management


JOB SUMMARY:


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 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 tools. Provide reports on intelligence and metrics related to study start-up activities.


AREAS OF RESPONSIBILITIES


Site Start-Up Packages


  • In cooperation with Project Management create study-specific start-up document package.
  • Distribute and follow up with sites to obtain the required executed documents.
  • Review content and correctness of returned documents from the sites, in accordance with internal standards.
  • In conjunction with Regulatory Affairs, ensure that the correct and complete packages are obtained within the planned timelines.

Site Contract and Budget Negotiation


  • In co-operation with Contract and Legal, obtain feedback on suggested site and investigator contract language.
  • Act as main point of contact for sites to obtain feedback on budget and contract negotiations.
  • In conjunction with the Project Manager, provide sites with the suggested study budget and negotiate within pre-approved margins.


Site Intelligence Tracking

  • Maintain site intelligence 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.
  • Provide input for suggested site list during start-up using past experiences with potential study sites.


Site Start-Up Planning and Tracking & Project Management support

  • Act as main contact for study sites during start-up.
  • Develop and maintain relationships with study sites that will facilitate timely completion of start-up.
  • In conjunction with project management and CRAs, plan start-up actions and provide expected SIV dates for individual sites based on previous start-up metrics, as well as regulatory and /RB timelines.
  • Track progress of start-up activities in smart sheet and/or CTMS.
  • 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.


QUALIFICATIONS:


Applicants should have a minimum of one to three years of related work experience with ongoing training, or a minimum of a one-year College Advance Diploma/Degree in a relevant field of study, preferable in Health or Life Sciences, or Clinical Research. The successful candidate must exhibit the following skills: Excellent communication skills. Knowledge of start-up requirements for clinical sites. Experience in working directly with clinical study sites through previous involvement in studies. Very high sense of urgency.


WORKING CONDITIONS

Home Based


  • Accommodations for job applicants with disabilities are available upon request.

As one of the leading companies in Canada, Alimentiv offers variety of opportunities for employees to grow and make them as future leaders of the professional and disciplined. Alimentiv also offers a dynamic work environment in order to encourage employees to give optimally, and at the same time, you are able to escalate new skills and erudition through the company programs.

If You are fascinated to submit an application for Study Start-Up Specialist Jobs Toronto March 2021 by Alimentiv, please prepare requirements files and documents immediately. To apply by online, please click the "Apply" button below. If you still do not satisfy with a job above, you can try to read more jobs list in Toronto region from another company below.


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