Senior Clinical Research Associate

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

📋 Description

• Assists in identifying potential investigators

• Oversees study start-up and regulatory upkeep as necessary

• Trains, supports, and advises investigators and site personnel on study-related issues

• Verifies that site personnel complete mandatory trainings, including ICH-GCP training

• Actively engages in Local Study Team (LST) meetings

• Initiates, monitors, and concludes study sites in accordance with the client’s Procedural Documents

• Enhances site performance and addresses study-related challenges

• Updates CTMS and other systems with information from study sites

• Manages study supplies and ensures drug accountability at study locations

• Conducts monitoring visits, remote data checks, Source Data Review, CRF review, and Source Data Verification

• Ensures timely resolution of data queries

• Collaborates with data management to maintain the quality of collected study data

• Guarantees accurate and timely reporting of Serious Adverse Events and their follow-ups

• Prepares monitoring visit reports in CTMS and provides feedback to the Principal Investigator

• Follows up on unresolved actions with study sites

⛳️ Requirements

• Bachelor’s degree in a related field, preferably in life sciences, or equivalent qualifications

• Strong knowledge of international guidelines such as ICH-GCP, and basic understanding of GMP/GDP

• Good understanding of applicable local regulations

• Adequate medical knowledge and the ability to learn about the relevant client’s Therapeutic Areas

• Basic comprehension of the drug development process

• Solid understanding of Clinical Study Management, including monitoring, study drug handling, and data management

• Exceptional attention to detail

• Strong written and verbal communication skills

• Effective collaboration and interpersonal skills

• Proficient negotiation skills

• Willingness to travel nationally and internationally as required

🏝️ Benefits

• Health insurance

• Professional development opportunities