Site Contracts Specialist I
Top Benefits
About the role
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, including clinical operations. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in 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 a committed, skilled, and customer-focused individual to join our winning team as a Site Contracts Specialist for our Toronto/Markham, Ontario, Canada on-site location.
Site Contracts Specialist:
The Site Contracts Specialist is responsible for supporting the site start up process of clinical studies by negotiating and executing Clinical Trial Agreements and their budgets. The Site Contracts Specialist is expected to carefully ensure the quality and timeliness of their negotiations. The Site Contracts Specialist 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 Site Contracts Specialist will feel comfortable asking questions of their senior negotiators. The Site Contracts Specialist must be professional when communicating with investigative sites or sponsors via email or telephone.
The Site Contracts Specialist will be assigned sites from several studies to gain experience in different therapeutic areas. They will report status updates to the Site Contracts Manager or Study Team as applicable and escalate any language or budget costs for review and approval. The Site Contracts Specialist will raise any changes in site circumstances as they arise that may delay critical timelines to Site Contracts Manager as well as the study team. The Site Contracts Specialist will understand which sites are designated as a priority and work with the Site Contracts Manager or study team to ensure the contracts are executed in a timely manner.
Key Accountabilities:
- The Site Contracts Specialist 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 Site Contract Manager 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 Site Contract Manager and study team, 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 or English/communication; Master's or JD preferred
- 1+ years of investigative site contracting experience with both the legal language and the budget.
Benefits & Compensation:
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com
Estimated Salary Range: $60,000-$70,000
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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Site Contracts Specialist I
Top Benefits
About the role
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, including clinical operations. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in 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 a committed, skilled, and customer-focused individual to join our winning team as a Site Contracts Specialist for our Toronto/Markham, Ontario, Canada on-site location.
Site Contracts Specialist:
The Site Contracts Specialist is responsible for supporting the site start up process of clinical studies by negotiating and executing Clinical Trial Agreements and their budgets. The Site Contracts Specialist is expected to carefully ensure the quality and timeliness of their negotiations. The Site Contracts Specialist 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 Site Contracts Specialist will feel comfortable asking questions of their senior negotiators. The Site Contracts Specialist must be professional when communicating with investigative sites or sponsors via email or telephone.
The Site Contracts Specialist will be assigned sites from several studies to gain experience in different therapeutic areas. They will report status updates to the Site Contracts Manager or Study Team as applicable and escalate any language or budget costs for review and approval. The Site Contracts Specialist will raise any changes in site circumstances as they arise that may delay critical timelines to Site Contracts Manager as well as the study team. The Site Contracts Specialist will understand which sites are designated as a priority and work with the Site Contracts Manager or study team to ensure the contracts are executed in a timely manner.
Key Accountabilities:
- The Site Contracts Specialist 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 Site Contract Manager 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 Site Contract Manager and study team, 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 or English/communication; Master's or JD preferred
- 1+ years of investigative site contracting experience with both the legal language and the budget.
Benefits & Compensation:
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com
Estimated Salary Range: $60,000-$70,000
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.