Clinical Research Associate jobs in Somerset, NJ

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 (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

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 in accordance with our Work from Home policy.

The Contracts Associate is responsible for preparing and negotiating contracts including clinical research contracts in support of clinical trial projects (i.e., Site CDA/NDA, Clinical Trial Agreements, Amendments, Facility Use Agreements, Notice Letters, etc.) and other business transactional contracts (i.e., CDA/NDAs, Master Services Agreements, Vendor Agreements, Data Processing Agreements, Licensing Agreements, etc.) with clients and vendors as needed. Prior experience with business transactional contracts is not required.

The Contract Associate is able to 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 on a project team to deliver contract and budget services on time and in accordance with applicable financial, contractual, and pharmaceutical research and development industry standards and regulations. They will ensure the successful negotiation and on-going management of clinical trial agreements with investigative sites located in the US and Canada. Successful candidates will approach negotiations with a positive, can-do attitude.

Key Job Accountabilities:

• The Contract Associate is able to 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 on 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.
• Ensures the successful negotiation and on-going management of clinical trial agreements with investigative sites located in the US and Canada.
• Feel comfortable working in many different treatment areas, including oncology.
• Develop and 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 site budgets and identify items that would not be applicable to a study and is prepared with appropriate push backs for unnecessary, or higher than FMV, site cost requests.
• Have a willingness to review and negotiate business contracts with clients and vendors and provide upper management guidance in that regard.
• Appraises contracts for completeness and accuracy and ensures adherence to guidelines, corrects documents, ensures proper formatting, spelling and professional presentation of the contract language.
• Tracks all site interaction in a timely and accurate manner and ensures that status updates to the client are fully descriptive.
• Track the delivery of services and ensure that agreed up project targets and/or milestones are being achieved.
• Works 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.
• Works with legal for contract language escalations and other compliance departments to minimize risk in clinical trials.
• Identifies and proactively raises issues to the study team or contracts management, as appropriate, prior to their becoming critical or creates 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.
• May participate in client meetings to review contract language, site negotiation issues and to expedite the contract approval and signing process.
• 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.
• 2-4 years of industry experience negotiating Clinical Trial Agreements, Amendments and Confidential Disclosure Agreements.
• Prior experience with business transactional contracts is appreciated but not required.
• Understands timely project management, detail orientation and high-quality service delivery.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)