Clinical Trial Contracts Officer

Location
California, United States
Posted
08 Jun 2019
End of advertisement period
08 Aug 2019
Ref
83430
Contract Type
Permanent
Hours
Full Time

 Do you want to provide administrative support for cutting-edge patient care? Do you enjoy customer service? Would you like to be part of a great team working in a fast-paced environment? The Research Management Group (RMG) serves as the institutional representative for all sponsored projects within the School of Medicine. Within RMG, the Clinical Trials (CT) Team focuses on assisting faculty who want to provide the latest drug, device, or treatment to patients.

RMG seeks a Clinical Trial Contracts Officer 1 (CT CO) to join our dynamic team. The CT CO will 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. CT COs hold delegated signature authority for agreements on behalf of the University once Certification Level 1 has been obtained.

The CT CO will serve as a member of the Clinical Trials in the Research Management Group (RMG) to provide timely, high-quality, and coordinated research administrative services to Stanford faculty and departments. The CT CO, as a member of the School of Medicine RMG, oversees the School’s research administration processes, and has responsibility 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 CT CO negotiates a variety of clinical research agreements, clinical trial agreements, clinical services agreements, confidentiality agreements, awards under master agreements, and subawards under industry agreements.

The CT CO advises and assists Stanford department administrators, principal investigators, and staff members; interprets and explains contract terms and conditions; and assists in the resolution of problems that develop in the course of projects by consulting with the investigator(s), staff, and sponsors. The Officer partners with School-based organizations and groups within the two Stanford hospitals.

As a professional staff member, the CTCO is an advocate for responsive, effective research administration processes. Through participation in on-going Lean initiatives, the office develops and implements ideas to improve processes and provides back-up support for her/his colleagues.

Duties include:

  • 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.

* Other duties may also be assigned.

DESIRED QUALIFICATIONS:

  • 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.

PHYSICAL REQUIREMENTS*:

  • 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.

* Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORK STANDARDS:

  • 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.

Additional Information

  • Schedule: Full-time
  • Job Code: 4507
  • Employee Status: Regular
  • Grade: I
  • Requisition ID: 83430

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