Contracts Associate

7 months ago

Markham, Canada Everest Clinical Research-Can Full time

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. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and 9 offices throughout Europe.

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.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a **Contracts Associate** for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.

**Contracts Associate**:
The Contract Associate will work with various contracts, including Investigative Site CDA/NDA, Clinical Trial Agreements, Amendments, Facility Use Agreements, and Notice Letters.

**Key Job Accountabilities**:

- The Contract Associate can perform in a fast-paced environment, create and reset priorities as the need arises, identify and raise issues before they become critical, and adjust quickly to the changes of a dynamic organization.
- They will participate in a project team to deliver contract and budget services on time, within budget, and in accordance with applicable financial, contractual, and pharmaceutical research and development industry standards and regulations.
- Ensure the successful negotiation and on-going management of clinical trial agreements with investigative sites located in the US and Canada.
- Be willing to work in many different treatment areas.
- 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.
- Other duties as assigned.

**Qualifications and Experience**:

- 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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