Clinical Trials Regulatory Specialist 1



Stanford University

Clinical Trials Regulatory Specialist 1

Job Number:
75597

Stanford University is seeking a Clinical Trials Regulatory Specialist 1 to be responsible for the administration and regulatory compliance of clinical research within the Departments of Neurology and Neurosurgery. Responsibilities will include regulatory preparation, maintenance and support for all clinical trials for numerous Principal Investigators. Projects include Industry Sponsored, federally funded, and PI-initiated trials. Additionally, the Clinical Trials Specialist will be responsible for assisting with protocol and consent development for federal grant submissions and PI-initiated trials.

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.
* - Other duties may also be assigned

DESIRED QUALIFICATIONS:
  • Three years of regulatory experience supporting clinical trials at an enrolling site for Industry Sponsored Trials, Federally funded Multi-center Trials, and PI-Initiated Trials. Experience with a local, academic IRB is preferable. Previous experience with IND/IDE Submission is helpful.
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.
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.

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.




Job: Research

Location: School of Medicine
Schedule: Full-time
Classification Level:

To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.






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