Lead Clinical Research Associate

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee investigator/site feasibility assessments, identification, and study initiation

• Track project timelines and patient recruitment, implementing necessary corrective and preventive actions

• Assess monitoring visit reports and ensure compliance with regional Monitor reporting

• Handle Monitor query resolutions, including observations from Central Monitoring

• Facilitate the flow of safety information and reporting of protocol/process deviations

• Manage clinical supplies in collaboration with vendors at both country and regional levels

• Maintain tracking systems specific to the study as well as corporate systems

• Serve as the primary communication link among Monitors, Site Management Associates, Regional Project Leads, and Project Managers

• Organize supervised monitoring visits and carry out visits

• Oversee site contracting and payment processes

• Lead project team calls at the country level and provide updates and reports on status

• Assess data integrity and compliance at the country, regional, and site levels

• Prepare sites for audits, participate in site audits, and coordinate the resolution of any findings

• Supervise the development and execution of CAPA

• Manage the review, handling, and reporting of process deviations

• Conduct initial training and monitoring visits for Monitors; mentor newly promoted Lead CRAs

• Prepare and deliver project-specific training sessions and presentations for Investigator Meetings

• Plan, execute, and report on site selection, initiation, routine monitoring, and closeout visits

• Ensure that subject recruitment targets and project timelines are outlined, communicated, documented, and achieved

• Guarantee timely communication with trial sites regarding Adverse Events and protocol/process deviations

• Oversee source data verification and follow up on data queries at the site level

• Review and manage risks associated with site-level studies

• Ensure the proper handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies

• Review essential study documentation and oversee the reconciliation of ISF/TMF

• Supervise the flow of documents and laboratory supplies between sites and central/regional labs or reviewers

• Provide project-specific training for site Investigators

• Assist in the preparation of regulatory and ethics committee submission packages

⛳️ Requirements

• Relevant educational qualifications such as MD, MPharm, RN, or a degree in Life Sciences, or an equivalent combination of education, training, and experience

• At least 4 years of site monitoring experience with involvement in global clinical projects as a Lead Monitor or equivalent

• Prior experience in monitoring or managing sites and Clinical Research Associates (CRAs)

• Familiarity with US and Canadian regulatory guidelines and practices

• Experience with monitoring visits for Phase I–III studies

• Strong experience in Oncology is preferred

• Experience in CAR-T Therapy, Cell Therapy, Gene Therapy, Radiation Therapy, Radiopharmaceuticals, or Nuclear Medicine is preferred

• Significant experience in Gastrointestinal (GI) conditions, including Crohn’s Disease, Ulcerative Colitis, or Irritable Bowel Syndrome (IBS) is preferred

• Full working proficiency in English

• Proficiency in MS Office applications

• Ability to plan and multitask effectively in a dynamic team setting

• Excellent skills in communication, collaboration, and problem-solving

• Willingness to travel up to 65%, based on project requirements

• Valid driver’s license, if applicable

• Must not require work visa sponsorship now or in the future

🏝️ Benefits

• Option for remote work

• Opportunities for career advancement

• Chance to acquire new knowledge and skills

• Work for a company that prioritizes its employees