Clinical Research Contracts Specialist
6 days ago
We are seeking a highly skilled and experienced Clinical Research Contracts Specialist to join our team at Everest Clinical Research Services Inc. As a key member of our contracts team, you will be responsible for negotiating and managing clinical trial agreements with investigative sites located in the US and Canada.
Key Responsibilities- Negotiate study-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), Amendments or other related contractual documents and follow the escalation processes as established with the client.
- Review site budget templates for accuracy against the protocol and foreseeing potential issues in negotiations.
- Understand or be willing to learn site budgets and identify items that would not be applicable to a study and push back on unnecessary, or higher than FMV, requests.
- Has a willingness to learn and take on negotiations of business contracts with clients and vendors and provide upper management guidance in that regard.
- Appraise contracts for completeness and accuracy and ensure adherence to guidelines, corrects documents, ensure proper formatting, spelling, and professional presentation of the contract language.
- Track all site interaction in a timely and accurate manner and ensure that status updates to the client are fully descriptive.
- Forecast and track the negotiation timelines and ensure targets or milestones are achievable.
- Escalate any issues to the Lead or Senior Contract Associates and study team that may delay projected execution timelines or scheduled SIVs.
- Work cross functionally with Clinical Operations and Project Management in support of timely site start-up for the conduct of clinical trials including accurate forecast of contract execution timelines.
- Identify and proactively raise issues to the study team or contracts management, as appropriate, prior to their becoming critical or creating risk.
- Identify those elements that trigger an out-of-scope activity (i.e. additional tasks requested, timeline shift, sites added to the study) and work with the study team to prepare Change Orders as needed.
- Bachelor's degree or international equivalent in a related field such as science/biology, business, English/communication, a JD or advanced degree preferred.
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Clinical Research Assistant
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Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob SummaryWe are seeking a highly skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc. As a key member of our clinical research team, you will be responsible for compiling and reviewing dataset specifications, annotated patient Case Report Forms, and other related programming documentation to ensure compliance with...
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5 days ago
Markham, Ontario, Canada Everest Clinical Research Services Inc. Full time $63,453 - $68,500Job SummaryWe are seeking a highly skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc.. As a key member of our clinical research team, you will be responsible for compiling and reviewing dataset specifications, annotated patient Case Report Forms, and other related programming documentation to ensure compliance with...
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Clinical Trials IWRS Oversight Specialist
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Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeCompany Overview: Everest Clinical Research Services Inc. is a comprehensive contract research organization (CRO) that delivers a wide array of expertise-driven clinical research solutions to pharmaceutical, biotechnology, and medical device sectors globally. We collaborate with renowned organizations and engage with some of the most innovative drugs,...
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Clinical Safety Data Specialist I
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Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeCompany Overview: Everest Clinical Research Services Inc. is a premier contract research organization (CRO) that delivers a comprehensive array of expertise-driven clinical research solutions to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with leading firms and engage with some of the most innovative drugs, biologics, and...
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