Jobs in Kirkland, Quebec, Canada | November 2024 Opportunities

DescriptionSenior Clinical Research Associate IISyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.Job responsibilitiesPerforms site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processesConducts Source Document Review of appropriate site source documents and medical recordsVerifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical recordsApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelinesUtilizes available hardware and software to support the effective conduct of the clinical study data review and captureVerifies site compliance with electronic data capture requirements.May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned.May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-outKnowledge of local requirements for real world late phase study designsChart abstraction activities and data collectionAs required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staffThe SMA II may be requested to train junior staffIdentify and communicate out of scope activities to Lead CRA/Project ManagerProactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.Identify operational efficiencies and process improvementsDevelop study and country level informed consent formsCollaborate with RWLP Regulatory team to ensure updated regulatory information is applied and sharedParticipate in bid defense meetingsProvide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.Participate in Case Report Form design and edit check development.QualificationsWhat we’re looking forBachelor’s degree or RN in a related field or equivalent combination of education, training and experienceKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsMust demonstrate good computer skills and be able to embrace new technologiesExcellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.Ability to manage required travel of up to 75% on a regular basisGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional Information:Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

As part of initiatives to promote inclusion and equity, we strongly encourage people who identify as Indigenous to apply to work at National Bank. This job listing is reserved for people who identify themselves as such.“Indigenous People" is a collective name for the original peoples of North America and their descendants. This includes First Nations, Métis, and Inuit.Working in customer service at one of National Bank’s call centres, you’ll support clients with their financial needs and help them use our electronic solutions. Come and thrive in a fast-paced and stimulating environment, in a full-time career that offers you numerous benefits.If you have any questions, feel free to contact our Recruitment colleagues Christina Chan (christinab.chan@bnc.ca) and/or Simon Beaulieu (simonx.beaulieu@bnc.ca).If you wish to apply, you can do so via this online job posting and we will contact you via email.Your compensationThe salary is between $21.50 and $23.50/hour depending on the position. Evening and weekend premiums may apply. We also offer a program to reimburse tuition fees.Your roleWe offer numerous job opportunities at our Client Contact Centres located in downtown Montreal and in Sherbrooke. Depending on your skills, availability, and interests, our recruitment team will guide you towards the best job option for you.When you join our team, your main responsibilities will be to: Take calls from clientsAssess their banking and financial needsGuide them towards the most suitable solutionYour scheduleYour work schedule is variable, and you’ll receive your schedule three weeks in advance. You must be available to work during the daytime, evenings, and weekends.Your teamYou will collaborate with colleagues who value passionate people and bold ideas. You’ll be part of a team that helps clients achieve their goals and you can always count on your colleagues to share their knowledge with you.Training and developmentSeveral options will be available to you: advance in your role, evolve in your sector, and more! You’ll have many choices because we encourage internal professional development. You will start with your cohort among our teams in March 2024 with an in-person training program lasting 3 to 4 months. Your on-the-job training will focus on how to help clients over the phone, and you'll be supported by a trainer.Prerequisites High school diploma or equivalentCustomer service experienceAbility to establish strong relationships with clientsYour benefitsIn addition to competitive compensation, upon hiring you’ll be eligible for a wide range of flexible benefits to help promote your wellbeing and that of your family. Health and wellness program, including many optionsFlexible group insuranceGenerous pension planEmployee Share Ownership PlanEmployee and Family Assistance ProgramPreferential banking servicesOpportunities to get involved in community initiativesTelemedicine serviceVirtual sleep clinicThese are a few of the benefits available to you. We have an offer that keeps up with trends as well as your needs and those of your family.Our dynamic work environments and cutting-edge collaboration tools foster a positive employee experience. We actively listen to employees’ ideas. Whether through our surveys or programs, regular feedback and ongoing communication is encouraged.We're putting people firstWe're a bank on a human scale that stands out for its courage, entrepreneurial culture, and passion for people. Our mission is to have a positive impact on peoples' lives. Our core values of partnership, agility, and empowerment inspire us, and inclusivity is central to our commitments. We offer a barrier-free workplace that is accessible to all employees.We want our recruitment process to be fully accessible. If you require accommodation, feel free to let us know during your first conversations with us. We welcome all candidates! What can you bring to our team?Come live your ambitions with us!