We are seeking a Clinical Research Associate who will be responsible for managing the day-to-day activities of one or more global clinical trials. Reporting to the Head of Clinical and Regulatory, the candidate will partake in activities including: developing clinical trial documentation, liaising with numerous parties including contracted vendors, global partners, clinical site personnel, and Cosm internal teams, monitoring the progress and conduct of ongoing trials, maintaining data quality, and managing clinical trial documentation and databases. The Clinical Research Associate will be also be responsible for ensuring that all activities are conducted in compliance with the trial protocol, ICH-GCP guidelines, and any applicable regulatory requirements. The successful candidate will leverage their superior critical thinking and communication skills, as well as their adaptability and resourcefulness to ensure the ongoing success of Cosm research initiatives.

The job will be located at Cosm’s manufacturing Lab at the MaRS Accelerator (101 College St.) in Toronto’s world-renowned Healthcare Technology hub alongside support within Cosm Medical as part of the Autodesk Residency Program within the same ecosystem.

Responsibilities include:

· Participates in the development of clinical trial protocols and related documentations, including case report forms, informed consent forms, monitoring plans, study contracts, study budgets, study specific procedures and reference/training materials.

· Participates in the identification and assessment of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.

· Ensures ethics approval is obtained and clinical trial contracts are signed, as required

· Ensures that all trial activities are conducted in accordance with the trial protocol, all applicable regulations, guidelines, local laws and Cosm procedures.

· Participates in the creation and maintenance of electronic data capture (EDC) system

· Conducts clinical trial site initiation visits (SIV’s); advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.

· Assist with development and execution of monitoring plans. Conducts monitoring visits and prepares associated documentation and reports.

· Participates in the development and implementation of subject tracking systems as well as (electronic) Site and Trial Master Files.

· Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.

· Coordinates the collection, delivery, entry, verification, and management of clinical trial data.

· Liaising with participating clinical sites and overseeing trial activities at participating sites.

· Liaising with contract research organizations, contracted vendors, and external collaborators to facilitate daily trial activities, as required.

· Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.

· Organizing and participating in team meetings and teleconferences, as required

· Performs miscellaneous job-related duties as assigned.

Knowledge, Skills & Abilities:

• Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical research methodology.
• Ability to set priorities and work independently with accuracy in a dynamic & fast-paced environment. Demonstrated self-motivation and the ability to take initiative
• Strong time management skills and the ability manage multiple competing priorities.
• Demonstrated ability in writing clinical research related documents.
• Strong ability to plan and organize.
• Excellent attention to details and ability to keep detailed and accurate records
• Ability to utilize critical thinking for problem solving.
• Ability to develop and deliver both oral and written presentations.
• Strong teamwork capabilities with flexibility to thrive in dynamic environments.
• Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
• Preferred: candidates with previous experience using electronic software for clinical trial management including electronic trial master file systems and/or clinical trial management systems.
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards, an asset.
• Must be fluent in English and posses solid writing abilities
• Strong Proficiency with MS Office software, Word, Excel, Google Suite

Education and Experience:

· At minimum, a Bachelors degree, or recognized equivalent, in a health or science-related discipline

· Postgraduate certificate in Clinical Research, strongly preferred

· Certification of or ability to obtain certification as a Clinical Research Professional (i.e. SOCRA, ACRP), preferred

· Knowledge of or experience in medical devices and/or ISO 13485, an asset

· 1+ years of prior clinical research experience, an asset

· Experience working on FDA or Health Canada regulated clinical trials, an asset

Physical Requirements and Environmental Conditions:

· High-stress and dynamic work environment.

· Position may require travel to clinics, hospitals, and conventions.

· Light to moderate work with 30 pounds maximum weight to lift and carry.

This is an opportunity to join our small and skilled team that is leading the way in creating a new personalized medical devices category for underserved women’s health conditions.

COSM is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.