Working Leader - Trial Launch Team

Working Leader - Trial Launch Team

06 Jan
|
Alberta Health Services
|
Edmonton

06 Jan

Alberta Health Services

Edmonton

Your Opportunity:

The Working Lead for the Trial Launch Team oversees and supervises study launch processes within the Clinical Trial Unit. This is vital to the Unit to facilitate timely, efficient and accurate startup of complex clinical trials involving Research Ethics, budget development, contract process and operational approval reviews. This position serves as the internal liaison between the Clinical Trials Tumor group staff, Principal Investigators, Finance team and Management with regards to study start up. The position operates as an external liaison and Clinical Trial Unit representation for startup with pharmaceutical companies, Clinical Research Organizations, Cooperative groups, Health Research Ethics Board of Alberta (HREBA)





and Northern Alberta Clinical Trials Centre (NACTRC).



Description:

Develop standardized processes for startup activities. Prioritization of the intake process for all studies and study amendments. Participates in meetings regarding start-up activities. Coordinates feasibility reviews, Site selection visits for all new studies. Liaison with the Senior Coordinator Quality Regulatory Compliance, Investigator Initiated Trials. (IIT) Project Manager and Quality and Regulatory Advisor. Daily oversight of the Ethics, Budget and Contract Coordinator. Acts as the escalation point for protocol activation issues and reviews any concerns or issues with the Clinical Trial Manager. Monitors and distributes workload within the team. Provides training, support and guidance to the staff. Track all study startup activities and provide timely reports to management. Troubleshoot logistical challenges in protocol implementation and maintain tools for participating investigators and research staff to access regarding the site start up process. Confirm all study requirements are in place for study activation. Monitor and improve processes.



Classification: Working Leader

Union: Exempt

Department: CCI CTU Indirect Cost

Primary Location: Cross Cancer Institute

Negotiable Location: Within Edmonton Zone

Temporary Employee Class: Temp F/T Benefits

FTE: 1.00

Posting End Date: 12-JAN-2022

Date Available: 22-JAN-2022

Temporary End Date: 28-FEB-2023

Hours per Shift: 7.75

Length of Shift in weeks: 2

Shifts per cycle: 10

Shift Pattern: Days

Days Off: Saturday/Sunday

Minimum Salary: $28.20

Maximum Salary: $48.45

Vehicle Requirement: Not Applicable



Required Qualifications:

Bachelor’s Degree in Science, Health or Clinical Research related field.



Additional Required Qualifications:

Minimum of 5 years related clinical trial experience in a healthcare, pharmaceutical/Clinical Research Organization, Research Ethics or clinical setting is required. Prior experience leading and supervising staff.



Preferred Qualifications:

ACRP/SoCRA certification preferred. Oncology Clinical Trial Research experience preferred. Good computer knowledge and experience including Excel. Strong interpersonal skills. Excellent communication skills. Organization skills.

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