Research Management Group (RMG)

Open Positions


bulletResearch Process Manager (RPM)


bullet Clinical Trial Research Process Manager (CT RPM)

bulletClinical Trial Contract Officer

For questions, please contact:

Karen M. Kellner
Human Resources Manager
Research Management Group
Stanford University School of Medicine
3172 Porter Drive, 2nd floor, Room 2115
Palo Alto, CA 94304-1212
Stanford Internal Mail Code: 5469
t: 650-498-6845
f: 650-721-2627
kkellner@stanford.edu


Research Process Manager (RPM)- Job # 67069, #67912
Job Code: 4491
Class:   G
School of Medicine

To apply for either position, go the Stanford Job Search webpage >> and enter "RPM" or position number under the keyword search.

Description


Stanford University is seeking a Research Process Manager 1 to under the guidance of the RMG Trainer, act as the institutional official with delegated signature authority for sponsored projects and fellowships in the School of Medicine ensuring compliance with Federal Regulations, University policies, and sponsor requirements. Provide a broad range of support for research administration to faculty, postdoctoral fellows, and department administrators with pre and post award activities.

Duties include:

  • Provide guidance to faculty, postdoctoral fellows, and department administrators using in-depth understanding of applicable federal regulations, sponsor requirements, and University policies such as OMB A-21, OMB A-110, Cost Accounting Standards, Food and Drug Administration and Medicare pricing and reimbursements.
  • Work with the principal investigator and department 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 in-depth understanding of University and sponsor requirements.
  • Review and approve proposals as the institutional official before submission.
  • 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.
  • Negotiate awards terms and conditions on behalf of the university and School.
  • Process and issue notice of award to department and to Office of Sponsored Research for account setup.
  • 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.
  • * Other duties may also be assigned

Qualifications

EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years of relevant experience, or an equivalent combination of education and experience.


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Expert knowledge and fluency of governmental regulations (e.g. Federal Acquisition Regulation, A-21, A-110, A-133, CAS).
  • Knowledge and ability to understand and interpret university and sponsor policies.
  • Demonstrated ability to work well with Stanford colleagues and clients and with external organizations.
  • Demonstrated commitment to personal responsibility and value for safety, shown through communication of safety concerns and use and promotion of safe behaviors based on training and lessons learned.
  • Excellent communication skills to convey university policies and pre and post award procedures to all levels of employees and faculty.


CERTIFICATIONS & LICENSES:

Must obtain School of Medicine Research Process Manager Certification Levels I and II.

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.

 

 

Clinical Trial Research Process Manager - 67628
Job Code: 4491
Class:   G
School of Medicine

To apply for either position, go the Stanford Job Search webpage >> and enter the position number 67628 under the keyword search.

DESCRIPTION

Stanford University is seeking a Clinical Trial Research Process Manager 1 under the guidance of the CTRPM Trainer/Team Manager. The CT RPM is the Institutional Representative for industry-funded clinical trials and clinical research projects, particularly with regard to budget and compliance. He or she will serve as the primary point of contact for sponsors and University clinical research staff. Working in collaboration with faculty and staff from departments, hospital units, and central University, the CT RPM directs and manages the clinical trial pre-award process to ensure timely, compliant and accurate budgets and payment terms. This includes protocol review, interpretation and application of pertinent FDA and Medicare regulations and University guidelines, developing budgets with coverage analysis, negotiating with sponsors, providing strategic advice to the PI, as well as providing institutional review and signature, indicating that the contract budgets and payment schedules/terms meets Medicare, FDA, sponsor, University, hospital and School pre-and post- award guidelines/regulations. The CT RPM accepts the budget on behalf of the School and University, provides expert consultation and oversight to ensure that sponsored research funds are managed and expended in compliance with internal and external policies, and continues as the institutional representative throughout the life of the award. The CT RPM is a senior professional staff member, promoting a collaborative model of stewardship among faculty and staff and is an advocate for a responsive, effective research administration process, in a customer-service organization.

CT RPMs undergo extensive and ongoing training, take certification exams and are trained and mentored by an experienced CT RPM Trainer/Manager. As a member of the RMG CT Team, the CT RPM works closely with a shared Associate and a partner CT Contract Officer, provides back-up to co-workers, and becomes an expert partner to teammates. CT RPMs also participate in problem-solving and continuous process- improvement efforts to improve customer service, efficiency and accuracy, and thus contribute to the success of the organization.

DUTIES INCLUDE:

  • Provide guidance to faculty, postdoctoral fellows, and department administrators using in-depth understanding of applicable federal regulations, sponsor requirements, and University policies such as OMB A-21, OMB A-110, Cost Accounting Standards, Food and Drug Administration and Medicare pricing and reimbursements.
  • Work with the principal investigator and department 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 in-depth understanding of University and sponsor requirements.
  • Review and approve proposals as the institutional official before submission.
  • 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.
  • Negotiate awards terms and conditions on behalf of the university and School.
  • Process and issue notice of award to department and to Office of Sponsored Research for account setup.
  • 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.
    * - Other duties may also be assigned

QUALIFICATIONS:

EDUCATION & EXPERIENCE (REQUIRED):

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

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Expert knowledge and fluency of governmental regulations (e.g. Federal Acquisition Regulation, A-21, A-110, A-133, CAS).
  • Knowledge and ability to understand and interpret university and sponsor policies.
  • Demonstrated ability to work well with Stanford colleagues and clients and with external organizations.
  • Demonstrated commitment to personal responsibility and value for safety, shown through communication of safety concerns and use and promotion of safe behaviors based on training and lessons learned.
  • Excellent communication skills to convey university policies and pre and post award procedures to all levels of employees and faculty.

CERTIFICATIONS & LICENSES:

Must obtain School of Medicine Research Process Manager Certification Levels I.

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.

 

 

Clinical Trial Contracts Officer - Position # 67910
Job Code: 4507
Class:   I

School of Medicine

To apply for either position, go the Stanford Job Search webpage >> and enter the position number 67910 under the keyword search.

DESCRIPTION:

Stanford University is seeking a Clinical Trial Contracts Officer 1 under guidance and review of Clinical Trial Team Manager prior to Certification, draft, negotiate and administer industry sponsored clinical trial agreements, subawards, collaborations, and other research-related agreements. Hold delegated signing 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 charged with overseeing the School’s research administration processes, is responsible for the formal solicitation, 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. The Officer is expected to provide back-up support for her/his colleagues, and develop and implement ideas for increasingly effective service.

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

QUALIFICATIONS:

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 intellectual property and licensing issues as they pertain to industry sponsored research.
  • 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.


CERTIFICATIONS & LICENSES:

None

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.


 

 

 

     

 

 


 

 

 

 

 



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