Clinical Trial Research Process Manager (Remote)

The Research Management Group (RMG) serves as the central resource and expert partner on research administration providing support and oversight of sponsored projects for the School of Medicine at Stanford University.

The Clinical Trials Research Management Group (CT RMG) within RMG is seeking a highly motivated individual to join our team. As part of CT RMG, you will work with Stanford faculty to discuss incoming clinical trials in order to develop and negotiate budgets while ensuring that the process remains compliant with federal, state, and institutional guidelines. You will be part of the pre-award process that brings the latest drug, device and other treatment options to Stanford patients. Our team is very supportive and there are many training and educational opportunities for both professional and personal growth.

As part of CTRMG, you will have extensive training and mentoring. There is a certification process that provides continual growth within the position. As a CTRPM, you will earn two levels of certification, each level expands your institutional signature authority. A remote work arrangement may be considered for candidates with the appropriate background and experience, depending on business needs of each unit. Remote workers' schedules are based in the Pacific Time zone. If you have experience in research administration and are interested in joining our team, please check out our job posting for more details!

Stanford University supports DEI/JEDI initiatives to create a culture of belonging https://careersearch.stanford.edu/diversity

Duties include:

• Provide guidance to faculty, clinical investigators, study coordinators and department administrators using in-depth understanding of applicable federal regulations, sponsor requirements, and University policies, such as: Uniform Guidance, Cost Accounting Standards, Food and Drug Administration regulations and Medicare pricing and reimbursements.
• Work with the principal investigator, study coordinators and department staff to provide oversight of the proposal preparation, budget negotiation and/or post-award activities for a large volume and diverse set of complex federal and non-federal sponsored research projects involving multiple sub-awards, principal investigators, and/or cross-school initiatives.
• Responsible for budget development based on a thorough understanding of University and sponsor requirements.
• Review, approve and submit proposals as the institutional official.
• Provide direction and counsel to faculty and department administrators regarding sponsored projects, and resolve issues relating to pre-award administration.
• Serve as the University representative liaison between the principal investigator and sponsor negotiating budget and payment terms.
• Negotiate awards terms and conditions on behalf of the university and School of Medicine
• Review and approve budget and payment terms of final award prior to issuance of award notification. Communicate award requirements to impacted departments.
• Provide guidance and assist in the resolution of post-award administration.
• Gain independence towards completing and passing Certification I which will authorize signature authority on a subset of sponsored projects.
• Contribute to process improvement through participation in team initiatives.

- Other duties may also be assigned

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and three years of relevant experience, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Knowledge of relevant governmental regulation (e.g. OMB Uniform Guidance, Cost Accounting Standards, Medicare, FDA, OHRP).
• Ability to understand and interpret university and sponsor policies.
• Strong analytical, interpersonal, and written and oral communication skills.
• Demonstrated ability to work well with Stanford colleagues and clients and with external organizations.
• Demonstrated commitment to personal responsibilities and value for safety, shown through communication of safety concerns and sue and promotion of safe behaviors based on training and lessons learned.

CERTIFICATIONS & LICENSES:

Must obtain School of Medicine Research Process Manager Certification Level 1.

PHYSICAL REQUIREMENTS:

• Frequently perform desk based computer tasks, seated work, use a telephone and use light/fine grasping.
• Occasionally write by hand, lift, carry, push pull objects that weigh up to 10 pounds.
• Rarely stand, walk, sort, and file paperwork or parts.

- 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.

WORKING CONDITIONS:

May work extended or non-standard hours based on project deadlines or business cycle needs.

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 $76,845 to $94,268 per annum.

Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. 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.

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.

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: 4491
• Employee Status: Regular
• Grade: H
• Requisition ID: 108487
• Work Arrangement : Remote Eligible