Job Information
Stanford University Clinical Trials Regulatory Specialist in Stanford, California
Clinical Trials Regulatory Specialist
School of Medicine, Stanford, California, United States
Research
Post Date Mar 27, 2024
Requisition # 102688
TheDivision of Pulmonary, Allergy, and Critical Care Medicine(PACCM) at Stanford University is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in PACCM. We are committed to strong clinical investigations including the evaluation of new pharmacologic agents, which offer potentially promising therapeutic benefits, as well as outcome studies which characterize clinical parameters to effect positive changes in patient care.
The PACCM is seeking a full-time Clinical Trials Regulatory Specialist (CTRS) to join our expanding clinical research program. This is an opportunity to work in an intellectually stimulating and collaborative research environment focused on the care of patients with lung diseases from a variety of causes. The CTRS will be responsible for the oversight and coordination of the regulatory and compliance aspects of multiple clinical research projects, including industry-sponsored, NIH, and PI-initiated clinical trials, and observational registries/biorepositories.
This position will work under the general direction of the PACCM Clinical Research Managers to provide regulatory expertise to ensure that our research activities comply with internal and external University policies. Excellent computer skills are required including MS Word and demonstrated proficiency in Excel. The candidate must also the ability to independently prioritize and manage regulatory needs of research projects under multiple faculty in our division. They must be detail-oriented and have strong problem-solving and organizational skills. Most importantly, the CTRS will possess superior written and verbal communication skills to effectively interact with multiple health care professionals, sponsors, and research staff. This position will be a remote work position.
Duties include:
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.
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):
Excellent communication 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 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.
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.
WORKING 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. Stanford University hasfive Regional Pay Structures. The compensation for this position will be based on the location of the successful candidate.
The expected pay range for this position is $67,000 to $103,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. 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. TheCardinal at Workwebsite 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.
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 andunique perksempower you with:
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.
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.
Discovery and fun. Stroll through historic sculptures, trails, and museums.
Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
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.
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 at stanfordelr@stanford.edu. For all other inquiries, please submit acontact 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.
Additional Information
Schedule: Full-time
Job Code: 4941
Employee Status: Regular
Grade: H
Requisition ID: 102688
Work Arrangement : Remote Eligible