Clinical Trial Solutions
Clinical Trials Contracts Specialist
Location
United States
Posted
5 days ago
Salary
Not specified
Job Description
Role Description
We are seeking a full-time, fully benefited Clinical Trials Contracts Specialist to join Vitalief in a fully remote position supporting our client, a leading academic clinical research center in New Jersey. The ideal candidate will bring extensive experience in clinical research contract review and negotiation, along with a strong understanding of regulatory, legal, and operational requirements. In this role, you will develop and sustain strategic partnerships with industry sponsors while ensuring the timely and effective review, negotiation, and management of clinical trial agreements and related research contracts.
Qualifications
- Bachelor’s degree in Paralegal Studies, Law, or related field required; JD preferred.
- Minimum of 3 years of clinical trial agreement review and negotiation experience, including at least 2 years within an academic medical research environment.
- Demonstrated experience negotiating both industry-sponsored and non-industry clinical trials.
- Strong knowledge of clinical research regulations and institutional policy frameworks.
- Excellent written and verbal communication skills, with the ability to convey complex information clearly and effectively.
- Proven ability to manage multiple priorities independently, exercise sound judgment, and collaborate effectively across departments.
- Detail-oriented, proactive, and committed to delivering exceptional customer service.
Requirements
- Independently review, interpret, negotiate, and process clinical trial agreements, nondisclosure agreements, and related contracts from legal, business, and technical perspectives, ensuring alignment with institutional policies and sponsor requirements.
- Develop and execute negotiation strategies that align with institutional policies, regulatory requirements, and sponsor expectations.
- Provide guidance on contract terms, risk assessment, and industry best practices.
- Collaborate with General Counsel, Risk Management, Research Commercialization, finance, and other internal stakeholders to resolve legal and business matters.
- Maintain proactive communication with sponsors and internal teams, providing timely updates and resolving contractual issues.
- Ensure contract packages are complete, accurate, and properly maintained, including electronic files and negotiation histories.
- Support timely study start-up by coordinating executed agreements and distributing required documentation upon SRB approval.
- Serve as a subject matter expert in clinical research contract management and maintain compliance with institutional, federal, and state regulations.
- Participate in performance improvement initiatives and ongoing training to remain current on regulatory and institutional requirements.
Benefits
- Work remotely while supporting high-impact clinical trials.
- Standard work hours: 8:00am to 4:30pm EST zone.
- Contribute to advancing scientific discoveries that improve patient lives.
- PEOPLE FIRST culture with opportunities for growth and innovation.
- Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.
- Market-competitive salary: commensurate with experience.
Physical Demands
- Standing, sitting, walking, visual perception, talking and hearing.
- Lifting up to 20lbs.
Important Note
Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
Job Requirements
- Bachelor’s degree in Paralegal Studies, Law, or related field required; JD preferred.
- Minimum of 3 years of clinical trial agreement review and negotiation experience, including at least 2 years within an academic medical research environment.
- Demonstrated experience negotiating both industry-sponsored and non-industry clinical trials.
- Strong knowledge of clinical research regulations and institutional policy frameworks.
- Excellent written and verbal communication skills, with the ability to convey complex information clearly and effectively.
- Proven ability to manage multiple priorities independently, exercise sound judgment, and collaborate effectively across departments.
- Detail-oriented, proactive, and committed to delivering exceptional customer service.
- Independently review, interpret, negotiate, and process clinical trial agreements, nondisclosure agreements, and related contracts from legal, business, and technical perspectives, ensuring alignment with institutional policies and sponsor requirements.
- Develop and execute negotiation strategies that align with institutional policies, regulatory requirements, and sponsor expectations.
- Provide guidance on contract terms, risk assessment, and industry best practices.
- Collaborate with General Counsel, Risk Management, Research Commercialization, finance, and other internal stakeholders to resolve legal and business matters.
- Maintain proactive communication with sponsors and internal teams, providing timely updates and resolving contractual issues.
- Ensure contract packages are complete, accurate, and properly maintained, including electronic files and negotiation histories.
- Support timely study start-up by coordinating executed agreements and distributing required documentation upon SRB approval.
- Serve as a subject matter expert in clinical research contract management and maintain compliance with institutional, federal, and state regulations.
- Participate in performance improvement initiatives and ongoing training to remain current on regulatory and institutional requirements.
Benefits
- Work remotely while supporting high-impact clinical trials.
- Standard work hours: 8:00am to 4:30pm EST zone.
- Contribute to advancing scientific discoveries that improve patient lives.
- PEOPLE FIRST culture with opportunities for growth and innovation.
- Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.
- Market-competitive salary: commensurate with experience.
- Physical Demands
- Standing, sitting, walking, visual perception, talking and hearing.
- Lifting up to 20lbs.
- Important Note
- Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
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