Job 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, We are looking for candidates to fill CRA positions who are specialized in pharmacokinetics (PK) and bioanalytical (BA) studies. Profile

• You must have, at minimum, a B.Sc. degree or equivalent; a Master\xe2\x80\x99s 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\xe2\x80\x99s 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.
• Monitoring of kinetic studies, for international Pharmaceuticals client to ensure CROs conformity with regulations, subject safety, and data integrity.
• Prepare bioanalytical and clinical study monitoring plan, as applicable.
• Conducts bioanalytical monitoring at different stages of the study (prior to sample analysis, in-process and data and report review) including start-up (Lead-in), 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.
• Quality control of bioequivalence studies, for international pharmaceutical clients to ensure phase I CROs\xe2\x80\x99 conformity with regulations, subject safety, and data integrity.
• Ensures that all regulatory documents and approvals are in place prior to patients\xe2\x80\x99 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 on-site visits and logistics (e.g. travel arrangements).
• Perform on site visits and reports in accordance with the monitoring plan.
• Conduct on-site study-specific training (if applicable).
• Perform site facilities inspection.
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations.
• Monitor and maintain ICH-GCP compliance.
• Responsible for the completeness and quality of the on-site files.
• Update all relevant tracking system on an ongoing basis.
• Escalate any issues that require immediate action to the CRA Coordinator/Project Lead.

What we offer At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues. We invest considerable time and resources in training our staff (technical and non-technical courses) to support you in your continuous personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits ( pension and health insurance, \xe2\x80\xa6) based on your background and experience. Who we are Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our human approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. At Keyrus Life Science we\xe2\x80\x99re proud of our commitment to deliver services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients\xe2\x80\x99 projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better. From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.