Clinical Trials Regulatory Specialist 1

Research

Clinical Trials Regulatory Specialist 1

Requisition ID 99556 Job Code 4941 Grade H Employee Status Regular Schedule Full-time Work Arrangement Remote Eligible

The

At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply!

Responsibilities will include regulatory preparation, e.g. IND/ IDE, maintenance and support for numerous Principal Investigators related to these submission to FDA and/ or IRB. In addition, position will be responsible for regulatory submission of single/ multi-site research study. Projects include Industry Sponsored, federally/ state funded, and PI-initiated clinical trials.

This is a remote role.

Duties Include

• 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.
• 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.
• Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
• Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.

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.

Desired Qualifications

• Master's degree preferred.

Education & Experience (required)

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

Knowledge, Skills And Abilities (required)

• Experience with MS Office products and database applications required.
• Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
• Strong writing skills.
• Excellent inter-personal skills and customer service focus is required.
• 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.

Physical Requirements

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
• Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.

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 Standards

• 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,
• 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.
• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.

This role is open to candidates anywhere in the United States. Stanford University has five

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The

Why Stanford is for You

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and

• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.

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.