Lead Clinical Research Associate, Toronto/Markham, Ontario, Canada Location
Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Lead Clinical Research Associate for our Toronto/Markham, Ontario, Canada location.
- Interact with the study sponsors, investigational sites, vendors and other Everest functional departments related to clinical monitoring and site management activities to ensure timely, high quality deliverables.
- Identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.
- Ensure quality of the clinical monitoring and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools. Author and maintain Clinical Site Monitoring Plan.
- Assist Project Manager with development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Everest and Sponsor Standard Operating Procedures (SOPs), Clinical Site Monitoring Plans, Data Management Plans and timelines for the study. Attend regular clinical Study Management Team (SMT) calls to provide status updates for deliverables.
- Understand the monitoring strategy required for the study and where required participates in the development of the study risk assessment and mitigation plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, Clinical Site Monitoring Plan and Risk Management Plans.
- Review the content and quality of site monitoring and management documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site monitoring and management activities and conduct. Ensure these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
- Routinely review Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan, and to oversee site and study team conduct and identify any risks to quality and delivery.
- Ensure assigned CRA routinely assess site processes, perform review of all Source Documents and medical records, and perform Source Document Verification (SDV) per the Clinical Site Monitoring Plan and review identified and newly emerging risks. Develop and executes corrective action plans at site and study level, proportionate to the risks identified. Utilize systems and tools to assess Key Risk Indicators (KRIs) and ensure that monitoring visits/calls are occurring in line with Clinical Site Monitoring Plan. Proactively collaborate with the data management functional oversight to plan towards data cut and lock deadlines.
- May conduct Co-Monitoring Visits with CRAs to evaluate staff’s ability and performance level to perform site visits according to company and/or sponsor standards, process, protocol and Clinical Site Monitoring Plan. May conduct study site initiation and/or closeout visits when required.
- Collaborate with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensure Inspection Readiness for Clinical Scope.
- Support CRAs in their efforts to prepare sites for audits conducted either by sponsors or regulatory authorities.
- Ensure alignment of clinical activities to budget, including identification of out of scope activities.
- May assist or participate in business development proposals, defense meetings and proposal development.
- May assist in developing and reviewing documentation of information provided to study subjects, including informed consent forms.
- Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines. Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.
- Plan and carry out professional development.
- Perform Senior CRA tasks as required.
- Bachelor’s degree in a life science or related field of study.
- Five years field monitoring clinical trials.
- Thorough knowledge of GCPs.
- Thorough comprehension of medical terminology.
- Excellent command of verbal and written English.
- Ability to travel a maximum of 70% of working hours is required.
How to Apply:
Please send your application along with cover letter to [email protected].
To find out more about Everest Clinical Research and to review other opportunities, please visit our WEB site at www.ecrscorp.com
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.