Stanford University is seeking a Clinical Trials Regulatory and Quality Specialist 1 to be responsible for the administration and regulatory compliance of clinical research within the university.
Duties include:
- Assist in developing, 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.
- Assist with development and management of electronic data capture systems. Test data collection and export methods. Assist with data analysis procedures.
- 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.
- Prepare committee responses to investigators, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.
- Other duties may also be assigned
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.
DESIRED QUALIFICATIONS:
- Experience with Investigator Initiated (IIT) Clinical Trials
- Experience with study monitoring of data or regulatory records
- Experience developing processes, policies or Standard Operating Procedures
- Certification in clinical research (such as ACRP, SOCRA, Stanford CROP or other programs)
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree and three years of related experience or a combination of relevant education and 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.
CERTIFICATIONS & LICENSES:
None
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.
