The Division 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.
Core Duties:
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.
Minimum Education and Experience
Bachelor’s degree and three years of related experience or a combination of education and relevant experience.
Knowledge, Skills and Abilities:
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.