Clinical Research Associate Specialized In - Montréal, Canada - Keyrus Life Science North America

Keyrus Life Science North America

Verified Company

Montréal, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Keyrus Life Science (KLS), is a full-service Contract Research Organization (CRO) providing biopharmaceutical and medical devices industries with a broad range of clinical research services from early to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs and medical writing,

Profile

You must have, at minimum, a B.Sc. degree or equivalent; a Master's degree in Drug Development would be considered an asset for the position.
You are located in the Great Toronto Area.
Fluency in English.
Must be able to travel 50%60% of the time in Quebec, Ontario, USA and India.
You hold a valid driver's license.
Ability to work independently and 100% remotely.
You must have either previous experience as a study Manager in pharmacokinetic studies, QA/QC in Bioequivalence and/or Bioanalytical studies or previous monitoring experience.
A clear understanding of clinical trials and an ability to perform your duties without assistance.
Understands and shares knowledge of, and requirements for assigned protocols.
Understands and implements ICH-GCP Guidelines and Standard Operating Procedures (SOPs) in daily work.
Demonstrate a commitment to quality.
Ability to build relationships of trust with customers and business partners and increase their satisfaction by meeting their requirements.
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word.
Strong regulatory knowledge including GCP.
Excellent interpersonal, verbal and written communication skills.
Sound problem solving skills.
Sound presentation skills.
Client focused approach and ability to interact professionally within a client organization.
Ability to prioritize multiple tasks and achieve project timelines.
Sense of urgency in completing assigned tasks.
Effective time management in order to meet daily metrics or team objectives.

Key responsibilities

Responsible for the monitoring of the PK and BA studies in compliance with the Protocol, GCP and Standard Operating Procedures (SOPs).
Responsible for the Initiation and Close-Out visits according to SOPs. Performs review of accountability records of investigational product and ensures reconciliation of records at Close-Out.
Assume the ability to meet the requirements of a CRA with a high degree of proficiency and autonomy.
Prepare bioanalytical and clinical study monitoring plan, as applicable.
Conducts bioanalytical monitoring at different stages of the study (prior to sample analysis, inprocess and data and report review) including startup (Leadin), sample analysis, chromatography review, and reporting of data.
Ensures that study is conducted in accordance with the Protocol (Study Plan), Bioanalytical Method, SOPs and applicable regulations.
Ensures that bioanalytical raw data and generated tables and documentation are accurately reported.
Reviews Validation of Bioanalytical Method.
Prepare study, facility and system audit plan and/or audit agenda, as applicable.
Conducts clinical and bioanalytical audits (facility, quality system and study specific audits).
Provides recommendations to management for continuous improvement of processes and procedures.
Ensures that all regulatory documents and approvals are in place prior to patients' enrolment with all sites.
Visits the assigned sites to ensure that the investigator and staff are qualified to conduct the study and that the facility and equipment are adequate.
Ensures that the test article is properly handled, stored and dispensed as per protocol specifications.
Ensures that the sites obtain and document proper informed consent.
Verifies proper completion of the Case Report Form (CRF) and source when applicable.
Performs regulatory document review during the study and ensures completeness of regulatory binder at the site.
Build relationships with investigators and site staff.
Participate in Investigator and other external or internal meetings as required.
Arrange onsite visits and logistics (e.g. travel arrangements).
Perform on site visits and reports in accordance with the monitoring plan.
Conduct onsite studyspecific training (if applicable).
Perform site facilities inspection.
Monitor patient safety onsite (review for missing SAEs, AEs, ConMed) and address protocol violations.
Monitor and maintain ICH-GCP compliance.
Responsible for the completeness and quality of the onsite files.
Update all relevant tracking system on an ongoing basis.
Escalate any issues that require immediate action to the CRA Coordinator/Project Lead.