Lead Clinical Research Associate

Psi-Cro; Toronto; On-site; CAD 124,000 - 153,000; Full time

Job summary

Psi-Cro is seeking a Lead Monitor/CRA to coordinate investigator/site feasibility, study startup, and monitoring across Phases I-III in Canada. You will manage timelines, enrollment, QA, and safety information flow. Travel up to 65% may be required.

You should have MD/MPharm/RN or Life Sciences degree, 4+ years site monitoring experience, and familiarity with US/Canadian regulatory guidelines. Oncology and cellular therapies are preferred; English fluency and MS Office proficiency are required.

Qualifications

• Must have relevant educational background (MD/MPharm/RN/Life Sciences)
• Strong communication and collaboration skills
• Ability to plan, multitask and work in a dynamic team environment
• Proficiency in MS Office applications

Responsibilities

• Coordinate investigator/site feasibility and study startup processes.
• Monitor project timelines and patient enrollment; implement corrective measures.
• Review monitoring visit reports and ensure reporting compliance.
• Manage monitors during query resolution and CAPA processes.
• Coordinate safety information flow and protocol deviations reporting.
• Oversee site contracting, payments and training of Monitors.
• Lead project team calls and provide status updates to leadership.
• Ensure data integrity and compliance at country/regional levels.
• Prepare regulatory submission packages and investigator site files.

Skills

English proficiency

Communication skills

Multitasking

Project coordination

Education

MD, MPharm, RN or Life Sciences degree

Tools

MS Office

Job description

• Compensation: CAD 124000 - CAD 153000 - yearly

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 providesstatus 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 4years’ site monitoring experience with participationin global clinical projects as a Lead Monitor or equivalentqualificationlevel.
• Must have prior experience monitoring or managing sites and CRAswith 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

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.