Clinical Research Associate
6 days ago
We are seeking a highly skilled and detail-oriented Clinical Research Associate to join our team at Everest Clinical Research Services Inc. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing administrative support to Data Monitoring Committees (DMCs) and performing various tasks related to clinical research.
Key Responsibilities- DMC Support: Serve as the DMC Secretary and perform hands-on administrative tasks for assigned projects, including but not limited to:
- Assist with the identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments.
- 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 all committee meetings, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter, according to the Charter.
- Project Management: 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.
- Project Coordination: Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, with high quality and meeting regulatory requirements.
- Communication: Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary.
- Quality Control: 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 submission.
- Medical Writing: Under supervision, perform medical writing tasks, including but not limited to, writing of the following documents: simple clinical study reports, simple study protocol, and other regulatory documents.
- Data Verification: Perform data verification (QC) on statistical programming outputs against data source such as patient case report forms or other information provided. Report discrepancies found during the QC procedure.
- Document Review: Perform consistency review of document formats, styles, and overall layout according to a document style guide.
- Document Publishing: Learn and perform 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.
- Safety Event Processing: 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 Lead 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.
- Safety Data Reconciliation: May assist with reconciliation of safety data between clinical and safety databases.
- Training and Development: Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.
- Education: M.Sc. or Ph.D. in a clinical or medical or health-related field.
- Experience: At least two years' clinical research experience in an academic, pharmaceutical, or CRO environment.
- Knowledge: Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards.
- Skills: 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 when working in a team and independently, using good judgment in making decisions (preferred).
-
Clinical Research Coordinator
5 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout the RoleWe are seeking a highly skilled and detail-oriented Clinical Research Associate to join our team at Everest Clinical Research Services Inc. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing administrative support to Data Monitoring Committees (DMCs) and performing various...
-
Clinical Research Coordinator
6 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout the RoleWe are seeking a highly skilled and detail-oriented Clinical Research Associate to join our team at Everest Clinical Research Services Inc. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing administrative support to Data Monitoring Committees (DMCs) and performing various...
-
Senior Biostatistician
4 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout UsEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries.Job SummaryWe are seeking a highly skilled Senior Biostatistician to join our team in Markham, Ontario or remotely from a home-based office in...
-
Senior Biostatistician
4 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout UsEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries.Job SummaryWe are seeking a highly skilled Senior Biostatistician to join our team in Markham, Ontario or remotely from a home-based office in...
-
Senior Biostatistician
9 hours ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout UsEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.Job SummaryWe are seeking a highly skilled and experienced Senior Biostatistician to join our team. The successful...
-
Senior Biostatistician
13 hours ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout UsEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.Job SummaryWe are seeking a highly skilled and experienced Senior Biostatistician to join our team. The successful...
-
Biostatistician - Clinical Research
6 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeJob SummaryWe are seeking a highly skilled Biostatistician to join our team at Everest Clinical Research Services Inc. as a key member of our statistical and data management center of excellence.Key ResponsibilitiesParticipate in and/or lead efforts in resolving day-to-day work-related issues and problems, securing quality, and improving efficiency and...
-
Biostatistician - Clinical Research
4 days ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeJob SummaryWe are seeking a highly skilled Biostatistician to join our team at Everest Clinical Research Services Inc. as a key member of our statistical and data management center of excellence.Key ResponsibilitiesParticipate in and/or lead efforts in resolving day-to-day work-related issues and problems, securing quality, and improving efficiency and...
-
Clinical Study Operations Manager
3 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timePosition: Clinical Operations Lead (COL)Everest Clinical Research Services Inc is a prominent Contract Research Organization (CRO) delivering extensive clinical research solutions to the pharmaceutical, biotechnology, and medical device sectors on a global scale. Established in 2004, Everest has evolved into a comprehensive service provider with a robust...
-
Clinical Study Operations Manager
3 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timePosition: Clinical Operations Lead (COL)Everest Clinical Research Services Inc is a prominent Contract Research Organization (CRO) that offers a wide range of clinical research solutions to the pharmaceutical, biotechnology, and medical device sectors on a global scale. Since its inception in 2004, Everest has established itself as a comprehensive service...
-
Clinical Study Operations Manager
3 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timePosition: Clinical Operations Lead (COL)Everest Clinical Research Services Inc is a prominent Contract Research Organization (CRO) that delivers extensive clinical research solutions to the pharmaceutical, biotechnology, and medical device sectors on a global scale. Established in 2004, Everest has evolved into a comprehensive service provider with a robust...
-
Clinical Research Associate
3 weeks ago
Toronto, Ontario, Canada Merck Full timeJob DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Clinical Research AssociateLocation: Toronto The role is...
-
Senior IWRS Monitor for Clinical Trials
3 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeCompany Overview:Everest Clinical Research Services Inc. is a reputable contract research organization dedicated to providing comprehensive clinical research solutions to the pharmaceutical, biotechnology, and medical device sectors globally. With a commitment to excellence, client satisfaction, and adaptability, Everest is a thriving organization that is...
-
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director, Statistical Programming to join our team at Everest Clinical Research Services Inc. This is a key leadership position that will play a critical role in driving the success of our clinical trials.Key ResponsibilitiesLead clinical trial programs/projects from start to finish,...
-
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director, Statistical Programming to join our team at Everest Clinical Research Services Inc. This is a key leadership position that will play a critical role in driving the success of our clinical trials.Key ResponsibilitiesLead clinical trial programs/projects from start to finish,...
-
Lead Clinical Data Manager
2 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeEverest Clinical Research Services Inc. is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices...
-
Clinical Data Management Lead
2 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeEverest Clinical Research Services Inc. is a leading contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device companies worldwide. We are renowned for our high-quality deliverables, exceptional customer service, and flexibility in meeting client needs. Our global presence...
-
Lead Clinical Trial IWRS Specialist
3 weeks ago
Toronto, Ontario, Canada Everest Clinical Research Services Inc Full timeCompany Overview:Everest Clinical Research Services Inc. is a reputable contract research organization dedicated to providing a comprehensive array of clinical research solutions to the pharmaceutical, biotechnology, and medical device sectors globally. With an unwavering commitment to quality outcomes, exceptional client service, and adaptability, Everest...
-
Clinical Research Associate-Contractor
3 days ago
Toronto, Ontario, Canada Tigermed Full timeJob SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Tigermed. As a Clinical Research Associate, you will be responsible for managing clinical studies from site selection to close-out, ensuring high-quality data and compliance with regulatory requirements.Key ResponsibilitiesStudy Site ManagementIdentify and select...
-
Clinical Research Associate-Contractor
3 days ago
Toronto, Ontario, Canada Tigermed Full timeJob SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Tigermed. As a Clinical Research Associate, you will be responsible for managing clinical studies from site selection to close-out, ensuring high-quality data and compliance with regulatory requirements.Key ResponsibilitiesStudy Site ManagementIdentify and select...
