Clinical Research Lead Jobs

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

Working closely with Principal Investigators and the ADI Director of Operations, the Clinical Research Lead will be responsible for overseeing the day-to-day operations of the CRU. The Clinical Research Lead will be involved of all aspects of clinical trials from start-up to close-out including new study feasibility, qualification visits, budget negotiation, ethics applications, AHS operational approvals, regulatory document management, informed consent, and data collection. The Clinical Research Lead is also responsible for directly supervising the work done by other CRU staff including Clinical Research Coordinators (CRCs) and Clinical Research Assistants (CRAs). Finally, the Clinical Research Lead will work closely with ADI management to promote the growth of the clinical trials program at the CRU, and to ensure financial sustainability.

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 cost-effective manner. Acts as a resource for CRCs and CRAs when they have questions related to the execution of study tasks.
• Negotiates study budgets.
• 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 start-up, and trial performance.
• Monitors workload of CRCs and CRAs and assigns tasks as appropriate.
• Develops, reviews, and revises SOPs. Works closely with Principal Investigators to ensure adequate training of other CRU staff.

Facility Maintenance And Operations

• 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.
• Provides oversight for the general upkeep of the CRU including the purchase of supplies and maintenance of equipment.

Clinical Trial Coordination

• Facilitates start-up, initiation, performance, and close-out 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
• Performs phlebotomy and serial blood collection via IV as a CRU service.
• Communicates regularly with Principal Investigators to ensure that they are aware of the status of their studies and participants.
• Provides other services as required within their professional scope of practice.
• Reviews, becomes knowledgeable about, and adheres to multiple research protocols including industry-sponsored clinical trials and investigator-initiated research studies. Provides training on protocols to other CRU staff 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.
• Collection worksheets according to the study protocol, submitting requests for operational approval to AHS facilities, and managing study supplies as required.

Minimum Qualifications

• Proficient with MS Office applications (Word, Excel, PowerPoint, and Outlook) and Google Apps (Drive, Docs, Sheets, and Calendar)
• Phlebotomy and IV certification
• Excellent interpersonal and communication skills, attention to detail, and precise documentation skills
• 3-5 years of experience working in a clinical research setting
• An undergraduate university degree in a medical or health-related field
• Actively registered or eligible for registration with a professional college related to their education and training
• Training in ICH Good Clinical Practice
• Proven ability to strategize, plan, design, propose, and coordinate multiple tasks and projects
• Problem solving and critical thinking skills

Preferred Qualifications

• Knowledge of administrative structures, policies, and procedures at the University of Alberta and Alberta Health Services
• Previous team leadership or management experience
• Experience using Connect Care
• Experience using ARISE and the NACTRC portal
• First Aid and CPR certification
• BSc in nursing
• Graduate university degree in a medical or health-related field