Senior Clinical Research Associate (Sr. CRA)

Thryv Therapeutics Inc.; Montreal (administrative region); Hybrid; CAD 90,000 - 120,000; Full time

Job summary

Thryv Therapeutics Inc. in Montreal, Canada is seeking a Senior Clinical Research Associate to lead site monitoring across the trial portfolio while shaping study conduct and processes for a growing rare disease program.

The candidate will manage SDV/SDR, regulatory documents, and site training, with heavy emphasis on in-house operations and cross-functional collaboration for data management and biostatistics. Travel up to 40–50% is expected.

Qualifications

• Bachelor's degree in life science or related field
• Minimum 4–6 years of clinical monitoring experience as a CRA
• Strong knowledge of ICH-GCP and FDA regulations
• Experience with EDC, CTMS, eTMF, IWRS/IRT

Responsibilities

• Site monitoring: qualification, initiation, routine/interim, and close-out visits (on-site and remote)
• Perform SDV/SDR, informed consent review, and drug accountability reconciliation
• Assess investigator/site compliance with protocol and regulatory requirements
• Maintain eTMF documents and inspection readiness
• Provide site training on study procedures and systems
• In-house operations: develop monitoring plans, SOPs, and study tools
• Support start-up activities and regulatory/contract document collection
• Collaborate with Data Management and Biostatistics on data reviews and cleaning
• Contribute to study plans, informed consent forms, and CRFs
• Mentor junior CRAs and support vendor oversight

Job description

Senior Clinical Research Associate (Sr. CRA)

ABOUT THE ROLE

Thryv Therapeutics is a clinical-stage biopharmaceutical company headquartered in Montreal, Canada, developing therapies for cardiovascular diseases. As a lean, fast-moving start-up, we are building our clinical operations function from the ground up, which means this role carries important ownership and visibility from day one.

We are seeking an experienced Senior Clinical Research Associate to serve as the primary site-facing monitor across our clinical trial portfolio, while also contributing directly to in-house clinical operations activities. This is an ideal role for a CRA who wants both the autonomy of independent site monitoring and a seat at the table in shaping study conduct, site strategy, and process build-out for a growing rare disease program.

This role requires a CRA who is comfortable working with highly specialized investigators and academic medical centers, exercising independent judgment, and adapting quickly as protocols and processes evolve.

KEY RESPONSIBILITIES

Site Monitoring (primary focus, ~40–50% of role)

Conduct site qualification, initiation, routine/interim, and close-out monitoring visits (on-site and remote) in accordance with the monitoring plan, protocol, ICH-GCP, and applicable regulations.

Perform source data verification/review (SDV/SDR), informed consent review, and drug management and accountability reconciliation.

Assess investigator and site staff compliance with the protocol, GCP, and regulatory requirements; identify and follow up on findings through to resolution.

Review and maintain site regulatory documents and essential documents in the eTMF, ensuring inspection readiness at all times.

Build strong working relationships with investigators, coordinators, and site staff; serve as the primary point of contact for assigned sites. May include weekly site calls, enrollment updates, protocol reminders, and operational guidance.

Support subject recruitment and retention strategies appropriate to population, including troubleshooting enrollment barriers at the site level.

Escalate safety signals, protocol deviations, and site-level risks promptly and manage corrective and preventive action plans (CAPAs).

Provide site training on protocol requirements, study procedures, and study-specific systems (EDC, IWRS/IRT, etc.).

Prepare timely, high-quality monitoring visit reports and follow-up letters.

In-House Clinical Operations Responsibilities (~50–60% of role)

Contribute to development and refinement of monitoring plans, visit report templates, and other clinical operations tools and SOPs appropriate for an early-stage company.

Support study start-up activities, including site feasibility, site selection, and regulatory/contract document collection and tracking.

Partner with Data Management and Biostatistics on data review, query resolution trends, and data cleaning activities ahead of database locks and interim analyses.

Provide input into study plans, informed consent forms, and case report forms based on site-level and operational feasibility.

Collaborate on study recruitment strategies, site engagement initiatives, and enrollment forecasting

Assist with vendor oversight, including day to day vendor collaboration with sites and overall vendor performance metrics.

Support implementation and optimization of clinical systems.

Support TMF quality control reviews and inspection-readiness activities at the study and program level.

Contribute to risk-based quality management activities, including central monitoring reviews and key risk indicator follow-up.

Mentor and provide guidance to junior CRAs or CRA contractors as the team scales.

Support the preparation of materials for meetings.

QUALIFICATIONS

Required

Bachelor's degree in a life science, nursing, or related field (or equivalent combination of education and experience).

Minimum 4–6 years of clinical monitoring experience as a CRA, including demonstrated ability to independently manage a full range of monitoring visit types with minimal oversight.

Solid working knowledge of ICH-GCP, FDA regulations (21 CFR Parts 50, 54, 56, 312), and applicable global regulatory requirements.

Experience with EDC, CTMS, eTMF, and IWRS/IRT systems.

Strong organizational skills and demonstrated ability to manage competing priorities across multiple sites and studies with limited internal infrastructure.

Excellent written and verbal communication skills; comfort interacting directly with principal investigators and site leadership.

Willingness and ability to travel approximately 40–50%.

Preferred

Prior monitoring experience in cardiovascular clinical trials.

Experience with rare or orphan disease studies, including small/specialized patient populations and natural history or registry studies.

Prior experience at a clinical-stage biotech or start-up, with comfort operating in a resource-constrained, rapidly evolving environment.

Familiarity with risk-based monitoring (RBM) approaches.