Clinical Trial Contracts Officer 1
Clinical Trial Contracts Officer 1
Job Number: 75334
Stanford University is seeking a Clinical Trial Contracts Officer 1. Prior to Certification, draft, negotiate and administer industry sponsored clinical trial agreements, subawards, collaborations, amendments, and other research-related agreements under guidance and review of Clinical Trial Team Manager. Hold delegated signature authority for agreements on behalf of the University after Certification Level 1 has been obtained.
The Contract Officer will serve as a member of the team in the Research Management Group (RMG) to provide timely, high-quality, and coordinated research administrative services to Stanford faculty and departments. The Officer, as a member of the School of Medicine RMG, is charged with overseeing the School's research administration processes, is responsible for the negotiation and administration of extramural support for University clinical research projects funded primarily by industry sponsors (sponsored projects). In addition to accepting awards on behalf of the University, the Contract Officer is responsible for negotiating a variety of clinical research contracts, clinical trial agreements, clinical services agreements, confidentiality agreements, awards under master agreements, and subawards under industry agreements.
The Officer is responsible for advising and assisting Stanford department administrators, principal investigators, and staff members; interpreting and explaining contract terms and conditions; and assisting in the resolution of problems that develop in the course of projects by consulting with the investigator(s), staff, and sponsors. The Officer will partner with School-based organizations and educate them regarding institutional processes.
As a professional staff member, the Officer is an advocate for responsive, effective research administration processes and is expected to participate and contribute to on-going Lean process improvements. The Officer is expected to provide back-up support for her/his colleagues, and develop and implement ideas for increasingly effective service.
- Conduct formal negotiations, finalize and administer industry sponsored clinical trial agreements, commensurate with experience.
- Negotiate liability provisions and publication rights, as well as confidentiality, intellectual property and invoicing terms.
- Negotiate complex Nondisclosure Agreements (NDA's) and draft language that complies with University, Federal and other regulatory policies, requirements and conditions. Negotiate liability issues involved in human subjects research.
- Negotiate other clinical research-related agreements that involve intellectual property, publication, liability and confidentiality issues.
- Assist in resolving contractual problems that arise during course of project by consulting with investigators, staff and sponsors.
Law or business degree or equivalent experience in contract drafting and negotiation.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of relevant experience or a combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated ability to draft, negotiate and conclude industry research agreements.
- Demonstrated understanding of liability and regulatory issues as they pertain to industry sponsored research and clinical trials.
- Demonstrated understanding of university research environment and policies.
- Advanced communication skills to clearly and effectively communicate information to internal and external audiences, client groups and all levels of management.
- Strong analytical and problem solving skills to review and analyze complex information.
- Strong service orientation, demonstrated ability to work effectively in a fast-paced, action-oriented, customer-focused service environment.
- Extremely detail oriented and able to work well independently, but also able to seek out assistance when needed.
- Excellent interpersonal skills, good judgment and the ability to conduct negotiations in a timely manner.
- Strong organizational skills and the ability to prioritize a variety of tasks and demands.
- Strong computer skills, including Microsoft Office Suite and ability to learn applicable university and departmental systems.
- Frequently perform desk based computer tasks, seated work and use light/ fine grasping.
- Occasionally stand, walk, use a telephone, lift, carry, push, and pull objects that weigh up to 10 pounds.
- Rarely writes by hand.
WORK STANDARDS (from JDL):
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Job: Compliance Legal
Location: School of Medicine
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.