Clinical Trials Regulatory Specialist 2 (Remote)

🔍 School of Medicine, Stanford, California, United States

New

📁: Research

📅   : 4 hours ago Post Date

📅   : 109319 Requisition #

Clinical Trials Regulatory Specialist 2 – Remote

The Stanford Cancer Institute (SCI) earned its most recent comprehensive cancer center designation by the NCI in 2022 and is one of an elite number of National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers in the country. The SCI is a prominent, dynamic, and complex Institute within the Stanford University School of Medicine and actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. Cancer clinical research is integrated throughout Stanford Medicine which is comprised of Stanford School of Medicine and our adult and pediatric health systems – Stanford Health Care and Stanford Children’s Health.

Given SCI’s mission, breadth, and depth, it employs over 400 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. You will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of healthcare in the cancer arena. Reporting to the Manager, Regulatory Operations, the Clinical Trials Regulatory Specialist 2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to perform job duties. We are seeking candidates with excellent Clinical Trials regulatory knowledge and communications Skills. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative, and flexibility.

Responsibilities include*:

Prepare and submit regulatory applications and documentation for clinical research studies, including IRB submissions, amendments, IND/IDE applications, IND/IDE annual reports, and IND/IDE withdrawals.
Maintain regulatory compliance across the study lifecycle and serve as a liaison with internal and external regulatory agencies, including IRBs, FDA, sponsors, and institutional stakeholders.
Provide regulatory guidance and support to principal investigators, study teams, and research staff to ensure adherence to federal, state, local, and institutional requirements.
Support regulatory applications for industry-sponsored, investigator-initiated, and collaborative clinical research studies.
Oversee and maintain regulatory documentation and safety reporting processes; ensure timely and compliant submission.
Monitor changes in applicable regulations and assess operational impact; implement updates to maintain compliance and improve regulatory processes.
Develop and deliver regulatory training and educational materials for research personnel, including onboarding, presentations, and one-on-one support.
Manage regulatory projects and initiatives to improve operational efficiency, quality, and study start-up processes.
Contribute to the development, implementation, and continuous improvement of Standard Operating Procedures (SOPs) and regulatory guidance documents.
Mentor and provide subject matter expertise to regulatory staff and research teams on IRB processes, FDA requirements, and clinical research regulations.
Collaborate across multidisciplinary teams to support high-quality clinical research operations and ensure timely study activation and maintenance.
Perform other duties as assigned in support of clinical research operations.

* - Other duties may also be assigned.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and five years of related experience or a combination of relevant education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Excellent communication and organizational skills and superb attention to detail.
Experience with MS Office products and database applications required.
Excellent inter-personal skills and customer service focus is required.
Experience in clinical research management and oversight, including project management in a dynamic research setting.
Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
Experience in developing and implementing training/education.
Demonstrated ability to manage multiple projects and staff under varying time constraints.
Strong writing skills.

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.

WORKING CONDITIONS:

May require occasional local and overnight travel.

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. The compensation for this position will be based on the location of the successful candidate.

The expected pay range for this position is $74,082 to $143,544 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