Clinical Trials Regulatory Specialist (12-Month Fixed-Term)

Stanford University; Palo Alto (CA); Remote; USD 90,000 - 130,000; Full time

Job summary

Stanford University’s Division of Body MRI seeks a Clinical Trials Regulator Specialist to coordinate regulatory planning and commercialization for ARPA-H LIGHT projects on MRI lymphatic imaging.

You will manage IRB submissions, regulatory roadmaps, and sponsor communications; assist in proposal documentation, milestones, and billing; and ensure compliance with FDA regulations and Good Clinical Practice. This is a remote opportunity.

Qualifications

• Bachelor’s degree and three years of related experience.
• Excellent communication skills and superb attention to detail.
• Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
• Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
• Strong writing skills.

Responsibilities

• Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
• Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
• Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
• Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.
• Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e., ClinicalTrials.gov.
• Collaborate on development of standard operating procedures, trainings, and documentation. May participate in delivering trainings.
• Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership.
• May serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
• May co-author committee responses to investigators, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.

Skills

Communication skills

Attention to detail

Interpersonal skills

Regulatory knowledge

Strong writing skills

Education

Bachelor’s degree and 3 years related experience

Tools

MS Office

Database applications

Job description

The Division of Body MRI, within the Stanford University Department of Radiology, is internationally recognized for excellence in clinical care, research, and education, as it relates to the diagnostic and interventional application of MRI in the body. The Body MR division aims to provide outstanding patient care, lead innovations in the practice of Body MR, and train the next generation of clinician scientists. The overall direction of the group is development of a tight link between diagnosis and therapy to enable highly personalized care.

We are seeking a Clinical Trials Regulator Specialist to coordinate planning for eventual clinical research, regulatory approval, and commercialization of the technologies developed from our ARPA-H LIGHT funded research team centered around improving the ability of MRI to evaluate the lymphatic system. Initially the hire will coordinate the development and implementation of commercialization plans and regulatory roadmaps by facilitating collaboration among investigators, sponsor representatives (ARPA-H), and institutional stakeholders. The plan will predominantly focus on the commercialization potential of new MRI contrast agents for lymphatic imaging, but may also include novel MR sequences for lymphatic imaging that we are also developing. The hire will also be tasked with project management duties such as coordinating team meetings, keeping track of completion task requirements, assisting in the organization of presentations including gathering of slide material from co-investigators, completing milestone billing material, centralizing team communication, assisting in scheduling of clinical research activity, maintaining IRB protocols, and serving as the lead contact for ARPA-H when the PI is unavailable. Pending confirmation of funding for phase 2 of the ARPA-H LIGHT program, this hire will transition to predominantly focus on coordination of translational and clinical research conducted for regulatory approval of the anticipated MR contrast agents. The role operates with minimal supervision and requires strong organizational skills, professionalism, and the ability to anticipate needs and solve problems independently. The ideal candidate brings together prior experience with research teams, drug development regulation, clinical trials, commercialization efforts, and Institutional Review Board (IRB) protocols, in addition to a basic knowledge of MRI technology.

This is a remote opportunity.

Additional Duties*:

• Assist researchers in the development of commercialization plans for the technology products being created, including the coordination of associated regulatory approvals.
• Interact with the principal investigator regularly, ensuring adherence to planned research timeline and completion metrics.
• Coordinating group meetings and associated presentation meeting for the sponsoring agency (ARPA-H). Coordination and submission of sponsoring agency required project documentation and billing.
• Assistance in preparation of proposal documentation for additional phases of funding.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

* - Other duties may also be assigned.

PHYSICAL REQUIREMENTS*:

• Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
• Occasionally sit, use a telephone or write by hand.
• Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.

* - 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.

Responsibilities

Core Duties

• Independently develop, draft and compile research protocoldocuments and all materials required for regulatory submissions incompliance with University and external policies.

• Manage and oversee new study initiation process, includingeducating study staff and sponsors, resolving issues and providingregulatory guidance and support.

• Facilitate and participate in committee meetings, ensureprocedures are followed. Responsible for compiling, organizing, andstoring all session documentation and communicating results asappropriate.

• Revise submissions for identified problems and issues and resolveany procedural issues that might arise in order to ensure timelyresponse; advise investigator on remedies and revisions.

• Maintain regulatory documents, monitor and recommend improvementsfor tracking regulatory documents. May assist with registering andreporting of clinical trials, i.e. ClinicalTrials.gov.

• Collaborate on development of standard operating procedures,trainings, and documentation. May participate in deliveringtrainings.

• Stay current on federal, state, and local regulations regardingclinical research and communicate changes to study staff and recommendrelated changes to leadership.

• May serve as primary liaison on safety issues and reportingprocedures with the IRB, OSR, RMG or other internal organizations orcommittees.

• May co-author committee responses to investigators, assure theseare reviewed, signed by the Chairperson, and communicated promptly tothe necessary parties.

Minimum Education andExperience

Bachelor’s degree and three years of related experience or acombination of education and relevant experience.

Knowledge, Skills and Abilities:

• Excellent communication skills and superb attention todetail.

• Experience with MS Office products and database applicationsrequired.

• Excellent inter-personal skills and customer service focus isrequired.

• Experience in clinical trials operations, knowledge of clinicaltrials regulatory requirements, or experience working with anIRB.

• Knowledge of regulatory affairs, including FDA regulations, IRBreview and approval process, and Good Clinical Practice.

• Strong writing skills.