Clinical Research Associate (CRA)

ABOUT ALETHIA BIOTHERAPEUTICS

Alethia Biotherapeutics is a Montreal-based clinical-stage oncology biotech. Our lead asset, sotevtamab (AB-16B5), is a monoclonal antibody targeting tumor resistance mechanisms, enabling existing immunotherapies to become significantly more effective. We do not replace current treatments: we enhance their efficacy.

ROLE CONTEXT

The Clinical Research Associate (CRA) delivers hands-on clinical monitoring for our Phase 2 oncology studies, from site qualification through close-out. Reporting to the Clinical Trial Manager, you are Alethia’s primary point of contact for your assigned sites.

Alethia is a team of 15 people. We are not looking for someone who simply executes: we are looking for a resourceful, proactive, curious person who spots what could be improved (a process, a tool, a way of working) and proposes concrete solutions instead of just flagging the problem. Here, your initiative will be noticed and your voice will count.

KEY RESPONSIBILITIES

• Plan and conduct site qualification, initiation, monitoring and close-out visits for assigned sites, in line with Standard Operating Procedures (SOPs), GCP (ICH-GCP), regulations, and each study’s monitoring plan
• Perform source data review/verification (SDR/SDV)
• Track and document adverse events (AEs) and serious AEs (SAEs) at assigned sites, per our procedures
• Identify and document protocol deviations, and take part in the quality review of deviations before closure
• Track research ethics board (REB) approvals and renewals
• Contribute to site feasibility assessment and selection
• Serve as the primary point of contact for assigned sites: communication, document follow-up, enrollment tracking, issue resolution
• Train site staff on the protocol and study procedures
• Promptly escalate any site or study issue to the Clinical Trial Manager, with proposed corrective actions, not just a flag
• Collaborate with contract research organizations (CROs) and other vendors involved in clinical studies
• Keep the eTMF up to date for assigned sites
• Participate in the implementation of CAPAs in collaboration with the Clinical Trial Manager
• Support sites and Alethia during audits and inspections (Health Canada, FDA)
• Contribute to the drafting and updating of SOPs related to clinical monitoring, and propose improvements to ways of working
• Contribute to other operational files per the Clinical Trial Manager’s priorities

QUALIFICATIONS

Education

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline (required); additional training in clinical research an asset

Experience

• Minimum 2 years of clinical monitoring experience in pharma, biotech, or a CRO
• Oncology or Phase 1-2 trial experience an asset
• ACRP (CCRA) or SOCRA (CCRP) certification an asset

Skills and Competencies

• Good knowledge of ICH E6 (GCP) and Health Canada and FDA regulations
• Experience using electronic data capture (EDC), clinical trial management (CTMS) and electronic trial master file (eTMF) systems
• Clear monitoring report writing, in both French and English
• Resourceful, proactive, and curious: comfortable taking initiative and proposing concrete solutions
• Rigorous and organized, able to manage multiple sites at once with limited supervision

Special Requirements

• Full bilingualism, spoken and written (French and English)
• Travel to sites as each study requires, up to 60% of working time, including overnight stays outside Montreal
• Valid driver’s license and reliable access to a vehicle

WHAT WE OFFER

Joining Alethia as a CRA means working on Phase 2 oncology studies at a decisive moment, in a human-scale organization where your ideas are heard and your contribution is felt immediately, by the team, the investigators, and ultimately the patients.

• Permanent, full-time position
• Montreal-based, hybrid between site visits
• Competitive annual salary commensurate with experience
• Group benefits and RRSP with employer contribution
• Opportunity to contribute beyond monitoring (SOPs, processes, quality)
• Start date: as soon as possible

HOW TO APPLY

Please submit your CV and a brief cover note to:

talents@alethiabio.com

Subject line: CLINICAL RESEARCH ASSOCIATE, FIRST NAME LAST NAME

Only candidates selected for an interview will be contacted.