Lead CRA

Lead CRA We are looking for a candidate who will mainly monitor the whole process around monitoring visit documentation such as monitoring report, confirmation and follow-up letters. In this role, you will answer the Clinical Operation Unit. This will be a full-time position. Responsibilities (including but not limited to): • Ensure monitoring visit reports, confirmation and follow up letters compliance with the monitoring plan, SOP and annotated trip report. • Ensure timelines review from the trip reviewers and CRAs are met. • Prepare evaluation reports on CRAs following co-monitoring visits. • Coach CRAs who needs extra training per evaluation report. • Assist CRA for co-monitoring visits • Participates in trip reviewers evaluations. • Participate in CRA protocol specific training. • Participate actively in CRA meeting/teleconference

Qualifications • Bachelor’s Degree in allied health field such as Nursing, Pharmacy, or Health Science or relevant health sciences educational background • Minimum of 5 years of clinical monitoring experience • Previous Senior CRA position Knowledge, Skills and Abilities • Verbal and written communication skills (French and English) • Organizational, record retention and time management skills • Decision making skills • Customer service and interpersonal skills • Knowledge of FDA regulatory requirements and GCPs • Leadership and coaching skills