Clinical Research Lead - Edmonton, Canada - University of Alberta

Sophia Lee

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Sophia Lee

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Description

MED AB Diabetes Research Inst:


  • Competition No.

S

  • Posting Date

Aug 28, 2023

  • Closing Date

Sep 08, 2023

  • Position Type

Full Time - Grant Funded

  • Salary Range

$64,618 to $90,053 per year

  • Grade

11

  • Hours

35
This position is a part of the Non-Academic Staff Association (NASA).

This position offers a comprehensive benefits package which can be viewed at: Faculty & Staff Benefits.


Location - North Campus Edmonton


Working for the University of Alberta

  • The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, Inuit and all First Peoples of Canada, whose presence continues to enrich our vibrant community._


The University of Alberta is teeming with change makers, community builders, and world shapers who lead with purpose each and every day.

We are home to more than 40,000 students in 200+ undergraduate and 500+ graduate programs, over 13,000 faculty and staff, 260,000 alumni worldwide and have been recognized as one of Canada's Greenest Employers for over a decade.


Your work will have a meaningful influence on a fascinating cross section of people—from our students and stakeholders, to our renowned researchers and innovators who are quite literally curing diseases, making discoveries and generating solutions that make the world healthier, safer, stronger, and more just.


Working for the Department/Faculty


The Alberta Diabetes Institute (ADI) is a stand-alone research facility dedicated to translating discovery science into health solutions for the prevention, treatment, and cure of diabetes.

Within the ADI, the Clinical Research Unit (CRU) offers services and support for industry sponsored and investigator initiated clinical trials.


Position

Duties

Project Team Lead Responsibilities:

  • Provides leadership and mentorship to other team members including CRCs and CRAs to ensure that projects follow sponsor timelines, study protocols, study budgets, Standard Operation Procedures (SOPs), International Conference on Harmonization Good Clinical Practice (ICH-GCP), and any other relevant policies or guidelines. Monitors, assesses, and manages project status on an ongoing basis to ensure project objectives are met in a timely and costeffective manner. Acts as a resource for CRCs and CRAs when they have questions related to the execution of study tasks.
  • Monitors workload of CRCs and CRAs and assigns tasks as appropriate.
  • Tracks and reports on the financial status of individual projects and the CRU as a whole. Tracks and reports on timelines and metrics related to site selection, study startup, and trial performance.
  • Negotiates study budgets.
  • Develops, reviews, and revises SOPs. Works closely with Principal Investigators to ensure adequate training of other CRU staff.

Facility Maintenance and Operations:

  • Provides oversight for the general upkeep of the CRU including the purchase of supplies and maintenance of equipment.
  • Works closely with the ADI leadership and the Human Nutrition Research Unit (HNRU) management team to jointly develop SOPs and agreements involving shared space and resources.

Clinical Trial Coordination:

  • Reviews, becomes knowledgeable about, and adheres to multiple research protocols including industrysponsored clinical trials and investigatorinitiated research studies. Provides training on protocols to other CRU staff as required.
  • Facilitates startup, initiation, performance, and closeout of studies. Monitors work done by CRCs and CRAs and assists with research ethics board submissions, developing site specific informed consent forms, gathering and managing regulatory documents, creating data
- collection worksheets according to the study protocol, submitting requests for operational approval to AHS facilities, and managing study supplies as required.

  • Monitors work done by CRCs and CRAs and assists with recruitment and screening of participants, scheduling of participant visits, the performance of study visits and collection of study data, data entry into databases, and the resolution of queries as required.
  • Communicates regularly with Principal Investigators to ensure that they are aware of the status of their studies and participants.
  • Performs phlebotomy and serial blood collection via IV as a CRU service.
  • Provides other services as required within their professional scope of practice.

Minimum Qualifications

  • An undergraduate university degree in a medical or healthrelated field
  • Actively registered or eligible for registration with a professional college related to their education and training
  • Training in ICH Good Clinical Practice
  • 35 years of experience working in a clinical research setting
  • Phlebotomy and IV certification
  • Excellent interpersonal and communication skills, attention to detail, and precise documentation skills
  • Problem solving and critical thinkin

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