Clinical Trial Project Lead

University of Alberta; Edmonton; Hybrid; CAD 85,000 - 115,000; Full time

Benefits offered by this job

N/A

Job summary

The University of Alberta is seeking a Clinical Trials Project Lead to oversee multi-site, national and international clinical trial operations. You will lead project teams, manage site activities, and report trial status and metrics to partners and leadership.

This hybrid Edmonton role requires coordinating regulatory compliance and ensuring timelines and budgets are met across sites. Ideal candidates have a science/health degree, several years of trial experience, and strong communication

Qualifications

• Undergraduate degree in science or health-related field; BScN desirable.
• Advanced degree and/or clinical research education (ACRP, SoCRA) desirable.
• Minimum four years of clinical trial experience including site monitoring and coordination.
• In-depth knowledge of ICH-GCP, FDA and Health Canada regulatory requirements.
• Ability to manage multiple projects and cross-functional teams.
• Strong interpersonal and written/oral communication skills.
• Team building skills and ability to work in a team environment.

Responsibilities

• Monitor and manage project status to meet objectives on time and budget.
• Assess resources, anticipate issues, and develop resolution strategies.
• Develop protocols and plans with team members and reviewers.
• Provide leadership to research sites to ensure compliance with timelines and SOPs.
• Plan projects and ensure activities align with study timelines and budgets.
• Assess risk, analyze issues, and implement effective solutions.
• Collaborate with team members to identify priority tasks and provide guidance.
• Document all operational aspects from site identification to closeout.

Skills

Project management

Cross-functional teams

Interpersonal communication

Team building

Regulatory knowledge

Education

Undergraduate science/health degree

Advanced degree or clinical research education

Tools

CTMS

INFORM

RAVE

RedCAP

Job description

Job Description

This position has a term length of 1 year plus 1 day.

This position has a term length of 1 year plus 1 day.

Location

This role is hybrid with a mix of remote and in-person work at North Campus Edmonton.

The Clinical Trials Project Lead (CTPL) develops, implements, manages, and evaluates research and administrative strategies essential to successfully conducting local, national and international clinical trial projects. The successful candidate leads project teams and research site personnel located at participating sites across Canada on one or multiple projects. This position assumes responsibility for the clinical trial projects' overall operation, coordination and project management aspects. It is responsible for reporting trial status, metrics and performance to academic partners, sponsors and trial leadership.

Responsibilities

• Monitors, assesses and manages project status on an ongoing basis to ensure project objectives are met in a timely, cost-efficient manner.
• Assesses and communicates project resource requirements, proactively anticipate project issues and develops ongoing resolution strategies to ensure successful project completion.
• Develops project protocols and associated plans and materials with the National Director and other research team members. Contributes to the ongoing review and modification of protocols to ensure continuing relevancy and subject safety.
• Provides leadership and guidance to research sites to ensure that each project complies with sponsor timelines, study protocols, Standard Operating Procedures (SOPs), ethics guidelines and other applicable regulatory requirements
• Develops project plans. Proactively anticipates project issues and develops strategies for resolution on an ongoing basis to ensure successful project completion on time and on budget. Responsible for ensuring all trial-related activities are delivered within the trial timelines as laid out in the scope of work.
• Proactively assesses risk, analyzes identified issues as they arise and provides effective solutions for the successful project continuation; communicates any resulting revised procedures/protocols to all participating project sites to ensure consistency.
• Works with project team members in identifying priority tasks and providing expertise and team leadership.
• Responsible for ensuring all operational aspects of the project are completed and accurately documented throughout each phase of the study, including site identification/feasibility, site selection, start-up process with each site, regulatory completeness, site activation, ensuring ongoing site recruitment and enrollment are in line with the study projections, ensuring follow up regularly with sites through the enrollment and follow up period on data entry, ensuring timelines are met for database lock and working closely with sites through closeout and archival of the study.

Qualifications

• Minimum of an undergraduate degree in science or health-related field; BScN is desirable.
• An advanced degree and/or completion of additional clinical research education (e.g., ACRP, SoCRA) is desirable.
• Minimum four years of clinical trial experience, including site monitoring and project coordination responsibilities.
• In-depth knowledge of clinical trial and drug development processes; ICH-GCP, FDA and Health Canada regulatory requirements.
• Demonstrated ability to manage multiple projects and cross-functional teams.
• Well-developed interpersonal communication skills, both oral and written.
• Team building skills and ability to work successfully in a team environment.

Additional Preferred Qualifications

• Bilingual English/French is an asset
• Intermediate computer experience: MS Word, MS Excel, MS PowerPoint, Gmail, SharePoint, Clinical Trial Management System (CTMS).
• Data management experience with Clinical Trial Databases (INFORM, RAVE, RedCAP)

About Us

The University of Alberta, its buildings, labs and research stations are primarily located on the territory of Néhiyaw (Cree), Niitsitapi (Blackfoot), Métis, Nakoda (Stoney), Dene, Haudenosaunee (Iroquois) and Anishinaabe (Ojibway/Saulteaux), lands that are now known as part of Treaties 6, 7 and 8 and homeland of the Métis. The University of Alberta respects the sovereignty, lands, histories, languages, knowledge systems and cultures of all First Nations, Métis, and Inuit.

The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more than 40,000 students and a growing community of 300,000 alumni worldwide.

Your work will have a meaningful influence on a fascinating cross-section of people - from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. Learn more.

At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.

All University employees have a responsibility to foster a workplace that prioritizes safety in all its forms—physical, cultural, and psychological. This is achieved by promoting a safe environment, adhering to all safety laws, policies and procedures, completing all required safety training, identifying hazards and implementing controls, reporting incidents, and contributing to a culture of belonging and respect, while endeavoring to ensure that all colleagues feel valued and safe to express their thoughts, perspectives and concerns.

The University of Alberta is committed to creating a university community where everyone feels valued, barriers to success are removed, and thriving connections are fostered. We welcome applications from all qualified persons. We encourage women, First Nations, Métis and Inuit persons, members of visible minority groups, persons with disabilities, persons of any sexual orientation or gender identity and expression, and all those who may contribute to the further diversification of ideas and the University to apply.

L’Université de l’Alberta s’engage à créer une communauté universitaire où chaque personne se sent valorisée, où les obstacles à la réussite sont éliminés et où des connexions enrichissantes peuvent se développer. Nous accueillons les demandes de toutes les personnes qualifiées. Nous encourageons les femmes; Premières nations, Métis et Inuits; membres des groupes minoritaires visibles; personnes handicapées; personnes de toute orientation sexuelle ou identité et expression de genre; et toutes les personnes qui peuvent contribuer à la diversification des idées et à l'université à postuler.

We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.

About The Team

The Faculty of Medicine & Dentistry is one of the world’s top academic health science centres. With 21 departments, multiple research institutes and centres, and a focus on excellence in education, research, and clinical care, the faculty trains outstanding medical and dental professionals and drives global health innovation in collaboration with partners across sectors.