Clinical Trial Contracts Officer 1
Stanford University

Job Info

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Clinical Trial Contracts Officer 1🔍School of Medicine, Stanford, California, United States📁Compliance Legal📅Dec 02, 2024 Post Date📅105358 Requisition #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 (CTCO) to join our dynamic team. The CTCO 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. CTCOs hold delegated signature authority for agreements on behalf of the University once Certification Level 1 has been obtained.

The CTCO 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 CTCO, 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 CTCO 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 CTCO 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 CTCO partners with School-based organizations and groups within the two Stanford hospitals.

As a key member of the team, the CTCO champions efficient and effective research administration practices. The office is committed to continuous improvement by actively engaging in School-wide initiatives to streamline processes, enhance collaboration, and support the success of research programs. Additionally, the CTCO provides backup support to colleagues, fostering a collaborative and agile work environment.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.

This role is open to candidates anywhere in the United States. Stanford University has five Regional Pay Structures. The compensation for this position will be based on the location of the successful candidate.The expected pay range for this position is $88,225 to $109,545 per annum.Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.Why Stanford is for You

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

Freedom to grow. We offer career development programs, tuition reimbursement, or course auditing. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.A caring culture. We provide superb retirement plans, generous time-off, and family care resources.A healthier you. Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.Discovery and fun. Stroll through historic sculptures, trails, and museums.Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.How to ApplyWe invite you to apply for this position by clicking on the "Apply for Job" button. To be considered, please submit a cover letter and résumé along with your online application.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.Additional Information

• Schedule: Full-time
• Job Code: 4507
• Employee Status: Regular
• Grade: I
• Requisition ID: 105358
• Work Arrangement : Remote Eligible

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