Senior Clinical Research Associate – FSP

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

📋 Description

• Oversee designated investigator sites from the activation phase until database lock.

• Execute site management tasks, including onsite and remote/electronic monitoring, initiation, routine checks, and closure of sites.

• Ensure compliance with the Study Monitoring Plan, relevant laws, Good Clinical Practice (GCP), and sponsor guidelines throughout clinical trials.

• Act as the main point of contact for assigned investigator sites and foster relationships with site investigators.

• Collaborate with Site Care Partners, study teams, vendors, investigators, and site personnel.

• Provide coaching, training, and protocol guidance to site staff.

• Assist in enrollment and recruitment strategies while addressing any activation and recruitment challenges.

• Monitor adverse events and serious adverse events, working closely with the Drug Safety Unit.

• Submit documentation for the Trial Master File (TMF), site reports, follow-up letters, protocol deviations, recruitment updates, supply details, and study metrics.

• Identify and address site-related issues, creating corrective and preventive actions as needed.

• Resolve data queries and carry out activities related to investigator site closure.

• Supervise the receipt, handling, accounting, storage, and destruction of investigational products.

• Assist with database release and, when suitable, take on unblinded monitoring responsibilities.

• Support patient safety, eligibility assessments, and clinical guidance.

• Facilitate remediation of Quality Events and corrective actions for audit observations when necessary.

⛳️ Requirements

• At least 3 years of relevant experience in monitoring clinical research sites.

• Comprehensive understanding of clinical trial methodologies, ICH/GCP standards, FDA regulations, and local country laws.

• Proficiency in English and the native language(s) of the country in which the individual will work.

• Willingness to travel 60–80% of the time.

• A valid driver’s license and passport are mandatory.

• A Bachelor’s degree in life sciences or a professional degree in a life sciences field such as nursing, pharmacy, or a medical background, or an equivalent qualification.

• Familiarity with the product, protocol, and therapy area adequate for engaging in discussions with investigators and site teams.

🏝️ Benefits

• Opportunities for travel ranging from 60–80% as part of the role.