Everest Clinical Research Services Inc.
Contracts Associate
Everest Clinical Research Services Inc., Bridgewater, New Jersey, United States,
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
Contracts Associate
may have prior experience negotiating site contracts or have experience working in a CRO or study site previously. There is a range of experience considered for different levels in this position. The Contract Associate is expected to carefully ensure the quality and timeliness of their negotiations. The candidate is responsible for timely site follow ups and will touch base with sites every 5 business days or every 3 business days for sites chosen as a priority. The candidate will feel comfortable asking questions of their senior negotiators. The Contract Associate must be professional when communicating with investigative sites or sponsors via email or telephone. The candidate will be assigned sites from several studies to gain experience in different therapeutic areas. This candidate will report status updates to the Lead or Senior Contracts Associate as applicable and escalate any language or budget costs for review and approval. The Contract Associate will raise any changes in site circumstances as they arise that may delay critical timelines to their Lead or Senior Contract Associate as well as the study team. The candidate will understand which sites are designated as a priority and work with their Lead or Senior Associates to ensure the contracts are executed in a timely manner.
The Contract Associate will work with various contracts, including Investigative Site CDA/NDA, Clinical Trial Agreements, Amendments, Facility Use Agreements, and Notice Letters.
Once a candidate is comfortable with negotiating site contracts, the Contracts Associate may be asked to perform reviews of other business transactional contracts (i.e., CDA/NDAs, Master Services Agreements, Vendor Agreements, Data Processing Agreements, Licensing Agreements, etc.) if interested. The candidate will be trained in this review as needed.
The Contract Associate must be 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 assigned to the study 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 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.
#J-18808-Ljbffr
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
Contracts Associate
may have prior experience negotiating site contracts or have experience working in a CRO or study site previously. There is a range of experience considered for different levels in this position. The Contract Associate is expected to carefully ensure the quality and timeliness of their negotiations. The candidate is responsible for timely site follow ups and will touch base with sites every 5 business days or every 3 business days for sites chosen as a priority. The candidate will feel comfortable asking questions of their senior negotiators. The Contract Associate must be professional when communicating with investigative sites or sponsors via email or telephone. The candidate will be assigned sites from several studies to gain experience in different therapeutic areas. This candidate will report status updates to the Lead or Senior Contracts Associate as applicable and escalate any language or budget costs for review and approval. The Contract Associate will raise any changes in site circumstances as they arise that may delay critical timelines to their Lead or Senior Contract Associate as well as the study team. The candidate will understand which sites are designated as a priority and work with their Lead or Senior Associates to ensure the contracts are executed in a timely manner.
The Contract Associate will work with various contracts, including Investigative Site CDA/NDA, Clinical Trial Agreements, Amendments, Facility Use Agreements, and Notice Letters.
Once a candidate is comfortable with negotiating site contracts, the Contracts Associate may be asked to perform reviews of other business transactional contracts (i.e., CDA/NDAs, Master Services Agreements, Vendor Agreements, Data Processing Agreements, Licensing Agreements, etc.) if interested. The candidate will be trained in this review as needed.
The Contract Associate must be 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 assigned to the study 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 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.
#J-18808-Ljbffr