Parexel

Senior Clinical Research Associate

Canada-Quebec-Remote · Senior

Sponsorship not specifiedDetected 21 days ago

GCPNegotiationClinical TrialsClinical ResearchGMPResearchCommunicationCollaborationProblem Solving

About the role

From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
We take our work personally, we do it with empathy and we're committed to making a difference.

Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the
Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
Initiates, monitors and closes study sites in compliance with client's Procedural Documents.
Drives performance at the sites.
Manages study supplies (ISF, etc), drug supplies and drug accountability at study site.
Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.
Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, client's SOPs and local requirements.
Supports/participates in regular QC checks performed by LSAD or delegate.

In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance.
Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study.
Updates CTMS and other systems with data from study sites as per required timelines.
If required, determines and discusses with LSAD the correct timing and type of visits.
Prepares and finalizes monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with client's SOP.
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

Ensures compliance with client's Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.