Clinical Trial Research Process Manager
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 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. We offer our CT Research Process Managers extensive training and mentoring and have created a certification process that provides continued growth within the position. As a CT RPM, you earn two levels of certification, with each level bringing expanded institutional signature authority. With certification there is also the opportunity for a regular 1-2 day work-at-home schedule.
- Provide guidance to faculty, postdoctoral fellows, 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 and Medicare pricing and reimbursements.
- Work with the principal investigator, study coordinators and department staff to provide oversight of the proposal preparation 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 Process Manager Certification Level 1.
- 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.
- May work extended or non-standard hours based on project deadlines or business cycle needs.
- 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.
- Schedule: Full-time
- Job Code: 4491
- Employee Status: Regular
- Grade: H