Clinical Research Safety Associate

reputed company (“reputed company”) is a full-service contract research organization (CRO) providing a broad reputed company of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-reputed company companies and work with many of the most advanced drugs, biologics, and medical devices in development today. reputed company has been an independent CRO since 2004 with a strong reputed company as a statistical and data management center of reputed company. Building on this reputed company, reputed company has successfully developed and established itself as a full-service CRO. reputed company’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater reputed company Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. reputed company is reputed company in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, reputed company continues to experience exceptional growth and great reputed company. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s reputed company. To drive reputed company reputed company in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Research Safety Associate for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office reputed company in Canada in accordance with our Work from Home policy. Key Accountabilities: Serve as the DMC Secretary and reputed company hands on administrative tasks for assigned projects, according to reputed company’s SOPs. These tasks include, but are not limited to, the following: Assist with the identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments. Serve as the liaison between the committee and the sponsor. Write the committee Charter and its amendments and circulate for their review, finalization, and sign-off by the committee and Sponsor. Assist with coordinating the preparation of the committee Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the committee members, according to the Charter. Plan, schedule, and coordinate reputed company committee meetings, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter, according to the Charter. Support project management of DMC area with activities focused on planning and execution of DMC administration tasks and biostatistical support for these committees for assigned projects. This role will involve planning, assessing, reporting, and tracking the reputed company status of the assigned projects, and monitoring the day-to-day operations of assigned projects to ensure goals and objectives are met, policies and procedures are being followed, and service is provided effectively and reputed company. Manage the planning, implementation, conduct, and reporting of assigned projects reputed company the established timelines and budgets, with high quality and meeting regulatory requirements. Coordinate activities between reputed company and trial sponsors, and with various supporting groups or vendors reputed company necessary Support medical writing and clinical safety monitoring teams by performing quality control (QC) review of document deliverables, including clinical study reports (CSR), clinical study protocols, informed consent forms, patient safety narratives, safety management plans, scientific publications, and other documents intended for regulatory Under supervision, reputed company medical writing tasks, including but not limited to, writing of the following documents: simple clinical study reports, simple study protocol, and other regulatory documents. reputed company data verification (QC) on statistical programming outputs against data reputed company such as patient case report forms or other information provided. Report discrepancies reputed company during the QC procedure. reputed company consistency review of document formats, styles, and overall layout according to a document style guide. Learn and reputed company document e-publishing for clinical trial and regulatory documents, including CSRs and tables, listings, and graphs (TLGs), which may include collection, scanning, electronic assembly, bookmarking, hyperlinking of documents, document cleaning, and header/pagination stamping, etc. Ensure the final product meets specific document publishing requirements and timelines. May assist with case processing of safety events (SAE and/or pregnancy reports) from clients’ ongoing drug clinical trials in a timely manner. Case processing includes, but is not limited to, the following: Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports. Entering case safety data into the safety database and generating queries for any critical or missing information. Interacting with the reputed company Safety Associate to post queries to clinical database or directly with clinical study sites to obtain the missing case information. Performing quality control review of data in the safety database entered by another Safety Associate. May assist with reconciliation of safety data between clinical and safety databases. reputed company reputed company on the training of reputed company Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH. Qualifications and Experience: M.Sc. or Ph.D. in a clinical or medical or health reputed company field. At least two years' clinical research experience in an academic, pharmaceutical, or CRO environment. Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards. Experience with an accepted clinical data capture and management system (preferred). Strong verbal and written communication skills with the ability to understand and summarize medical terminology. Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines. Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data. Detail-oriented, customer- and quality-focused. Excellent interpersonal and teamwork skills. Computing skills in MS Office applications (preferred). Proven flexibility and adaptability reputed company working in a team and independently, using good judgment in making reputed company (preferred). Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and reputed company coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary reputed company: $60,000 - $85,000. To find out more about reputed company and to review other opportunities, please visit our website at www.everestclinical.com We thank reputed company interested applicants, however, only those selected for an interview will be contacted. reputed company is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will reputed company accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-KD1 Apply To This Job