Lead Clinical Research Associate

PSI CRO AG

Lead CRA overseeing clinical trials at PSI, focusing on remote monitoring and study quality assurance. Requires extensive clinical monitoring experience and strong oncology background.

Posted 6/9/2026full-timeRemote • 🇨🇦 CanadaSenior💰 CA$130,000 - CA$160,000 per yearWebsite

About the role

Key responsibilities & impact

Coordinates investigator/ site feasibility and identification process, as well as study startup.
Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
Manages Monitors in the query resolution process, including Central Monitoring observations.
Coordinates safety information flow and protocol/process deviation reporting.
Performs clinical supplies management with vendors on a country and regional level.
Ensures study-specific and corporate tracking systems are updated in a timely manner.
Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Coordinates planning of supervised monitoring visits and conducts the visits.
Manages the project team in site contracting and payments.
Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
Oversees project team in CAPA development and implementation.
Coordinates project team in process deviations review, management and reporting.
Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
Delivers trainings and presentations at Investigator Meetings.
Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
Ensures data integrity and compliance at a site level.
Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
Conducts project-specific training of site Investigators.
Supports preparation of draft regulatory and ethics committee submission packages.

Requirements

What you’ll need

Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
Experience with all types of monitoring visits in Phases I-III.
Strong experience in Oncology preferred.
Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
Full working proficiency in English.
Proficiency in MS Office applications.
Ability to plan, multitask and work in a dynamic team environment.
Excellent Communication, collaboration, and problem-solving skills.
Ability to travel up to 65% (depending on project needs).
Valid driver’s license (if applicable).

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account PSI CRO AG Website LinkedIn All Job Openings 1001 - 5000 employees Founded 1996 ⚕️ Healthcare Insurance 💊 Pharmaceuticals 🔬 Science Healthcare Insurance
Pharmaceuticals
Science PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years. Lead Clinical Research Associate 🔥 22 minutes ago 🇨🇦 Canada – Remote 💵 $130k - $160k / year ⏰ Full Time 🟠 Senior 🔬 Research Analyst Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Coordinates investigator/ site feasibility and identification process, as well as study startup.
Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
Manages Monitors in the query resolution process, including Central Monitoring observations.
Coordinates safety information flow and protocol/process deviation reporting.
Performs clinical supplies management with vendors on a country and regional level.
Ensures study-specific and corporate tracking systems are updated in a timely manner.
Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Coordinates planning of supervised monitoring visits and conducts the visits.
Manages the project team in site contracting and payments.
Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
Oversees project team in CAPA development and implementation.
Coordinates project team in process deviations review, management and reporting.
Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
Delivers trainings and presentations at Investigator Meetings.
Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
Ensures data integrity and compliance at a site level.
Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
Conducts project-specific training of site Investigators.
Supports preparation of draft regulatory and ethics committee submission packages. 🎯 Requirements
Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
Experience with all types of monitoring visits in Phases I-III.
Strong experience in Oncology preferred.
Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
Full working proficiency in English.
Proficiency in MS Office applications.
Ability to plan, multitask and work in a dynamic team environment.
Excellent Communication, collaboration, and problem-solving skills.
Ability to travel up to 65% (depending on project needs).
Valid driver’s license (if applicable). Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Senior Clinical Research Associate, FSP 🕒 3 days ago Parexel 10,000+ employees ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Clinical Research Associate ensuring study commitments at allocated sites while collaborating with study teams. Responsible for monitoring site conduct and managing study supplies. 🇨🇦 Canada – Remote 💰 Venture Round on 1990-01 ⏰ Full Time 🟠 Senior 🔬 Research Analyst Senior Clinical Research Associate - FSP 🕒 3 days ago Parexel 10,000+ employees ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Clinical Research Associate working with clinical studies at assigned sites for Parexel. Ensuring compliance with regulatory standards and efficient study conduct. 🇨🇦 Canada – Remote 💰 Venture Round on 1990-01 ⏰ Full Time 🟠 Senior 🔬 Research Analyst Bilingual Clinical Research Associate, CRA II 🕒 May 29 Thermo Fisher Scientific 10,000+ employees 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science Website LinkedIn All Job Openings Clinical Research Associate conducting compliance assessments and monitoring across clinical trial sites for a leading pharma support organization. Managing documentation and ensuring data integrity in clinical studies. 🇨🇦 Canada – Remote ⏰ Full Time 🟠 Senior 🔬 Research Analyst 🗣️🇫🇷 French Required Senior Clinical Research Associate 🕒 May 29 ICON plc 10,000+ employees 💊 Pharmaceuticals 🧬 Biotechnology ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Sr. Clinical Research Associate overseeing clinical trial sites and ensuring compliance with regulatory requirements at ICON. Managing site performance and collaborating with cross-functional teams. 🇨🇦 Canada – Remote ⏰ Full Time 🟠 Senior 🔬 Research Analyst 🗣️🇫🇷 French Required Senior Clinical Research Associate 🕒 May 15 Parexel 10,000+ employees ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Clinical Research Associate ensuring study delivery and compliance at clinical sites in Quebec. Collaborating with local study teams and providing training to investigators and staff on oncology studies. 🇨🇦 Canada – Remote 💰 Venture Round on 1990-01 ⏰ Full Time 🟠 Senior 🔬 Research Analyst 🗣️🇫🇷 French Required View More Research Analyst Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

site monitoringclinical project managementdata integritycomplianceCAPA developmentadverse event reportingsource data verificationclinical supplies managementregulatory submission preparationOncology

Soft Skills

communicationcollaborationproblem-solvingplanningmultitaskingmentoringleadershiptrainingpresentationteamwork

Certifications

MDMPharmRNLife Sciences degree