Lead Clinical Research Associate

Company Description PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job 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. Qualifications 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 with knowledge of US and Canadian 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). Additional Information For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future. Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first. Compensation: CAD 124000 - CAD 153000 - yearly

The Lead Clinical Research Associate coordinates site feasibility, study startup, and monitors project timelines while ensuring data integrity and compliance. They also manage project teams, oversee site monitoring visits, and act as the primary communication link between various stakeholders.

Candidates must have at least 4 years of site monitoring experience in global clinical projects, including Phases I-III. A degree in Life Sciences or a related field is required, along with proficiency in US and Canadian regulatory guidelines.

• Problem solvingPreferred
• CommunicationPreferred
• Project managementPreferred

Identified from the job description. Confirm important requirements above.

• Clinical research
• Site monitoring
• Project management
• Regulatory compliance
• Oncology
• Data integrity
• Risk management
• Team leadership
• Mentoring
• Protocol deviation management
• Investigational product management
• Regulatory submissions
• Communication
• Problem-solving
• Multitasking
• MS Office
• Accountability
• Ethical Standards And Conduct
• Valid Driver's License
• Planning
• Research
• Auditing
• Reconciliation
• Management
• Corrective And Preventive Action (CAPA)
• Cell Therapy
• Clinical Research
• Clinical Trials
• Data Integrity
• English Language
• Innovation
• Radiation Therapy
• Problem Solving
• Life Sciences
• Project Management
• Nuclear Medicine
• Presentations
• Project Coordination
• Radiopharmacology
• Site Selection
• Timelines
• Coordinating
• Colitis

• Science & Research
• Healthcare
• Management & Leadership
• Lead Clinical Research Associate
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers

Minimum education

Bachelor’s degree

Minimum experience

5+ years

Posting language

English

Working hours

40 hours per week