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Clinical Research Safety Associate

Everest Clinical Research

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You'll advance clinical trials by expertly managing critical safety data and committee operations.

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Full-time

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2 months ago

Serve as the DMC Secretary and perform hands-on administrative tasks for assigned projects according to Everest SOPs. Coordinate the identification, recruitment, and engagement of committee members, including contract negotiations and administration of honorarium payments. Act as the liaison between the committee and the sponsor. Write the committee Charter and amendments, circulate for review, finalization, and sign-off. Assist with coordinating the preparation of committee Data Reports by external or internal teams and deliverables to committee members per the Charter. May assist with case processing of safety events (SAE and/or pregnancy reports) from ongoing clinical trials. Review SAE/device incident/pregnancy report forms and supplementary reports. Enter case safety data into the safety database and generate queries for missing or critical information. Stay current on Everest Guidance Documents and regulatory requirements from trial regulators and ICH.

About Everest Clinical Research:

Everest Clinical Research ("Everest") 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 in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Operating primarily in North America, with headquarters located in Markham, Ontario (Greater Toronto Area), Canada, with additional offices in Bridgewater, New Jersey, USA, Shanghai, China, Taipei, Taiwan, and Sofia, Bulgaria, Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest! Important Information for job candidates: Please be aware of cyber-security due to some fraudulent job scams. Everest will follow our standard and thorough recruitment process which will include video panel interviews: https://www.ecrscorp.com/recruitment-process/ Everest email communication will come from an ecrscorp.com email address. Emails from other domains may not be from Everest. Everest will never ask for credit card information or charge fees at any time during the recruitment process. If something is portrayed as Everest but does not appear to be from Everest, please feel free to contact us at https://www.ecrscorp.com/contact/

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Domain created: Feb 2018

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