Clinical Trials Regulatory Specialist 2

Job description

Clinical Trials Regulatory Specialist 2🔍School of Medicine, Stanford, California, United States📁Research📅Oct 09, 2020 Post Date📅87506 Requisition #Stanford University is seeking a ClinicalTrials Regulatory Specialist 2 to be responsible for theadministration and regulatory compliance of clinical research within theuniversity, and representing the university with external regulatory agencies,both domestic and international.

Duties include:
  • Prepare regulatorysubmissions (such as IRB and IND/IDE) and applications and annual reports.Complete all related regulatory documents and maintain correspondence andtelephone contacts with regulatory agencies. Submit annual reports and updatesas required.
  • Serve as expert liaisonin specialized compliance or scientific area between the investigators andregulatory agencies. Provide regulatory support, guidance, and information toprincipal investigators and research staff. May consult on protocoldevelopment.
  • Develop, deliver andmanage tools to facilitate education and training, prepare written materials tocommunicate with research community including presentations, one-on-onetraining and orientation sessions.
  • Oversee and maintainregulatory documentation, safety reporting procedures and audit safety reportsto ensure they are appropriately handled.
  • Evaluate and analyzethe impact on new regulations and determine how to implement within unit. Applyknowledge of international, federal, state and local regulations as well asuniversity policies to ensure optimal compliance.
  • Serve as primaryliaison on safety issues and reporting procedures with the IRB, OSR, RMG orother internal organizations or committees.
  • May manage projectsrelated to regulatory activities and clinical operations, develop theregulatory strategy for project teams.
  • May hire, orient, andprovide ongoing training and direct supervision to regulatory staff. Assignwork tasks, provide daily supervision of these tasks; provide verbal andwritten evaluation of work performance.
  • May contribute toestablishing and developing Standard Operating Procedures for the conduct ofclinical research. Ensure SOPs are compliant with international, federal,state, and local regulations, and consistent with the objectives of theclinical research operation.
* - Other duties may also be assignedDESIREDQUALIFICATIONS:

  • Experience submitting regulatorydocuments to the NCI CIRB, or other central Institutional Review Board.
  • Ability to multi-task, manage, andreport on up to 5 new studies and/or 7 amendments/revisions at one time.
  • Knowledge of oncology and clinicalresearch conduct desired.
  • Experience developing and deliveringtraining.
  • Certification through a professionalorganization such as RAPS or SOCRA preferred.

Bachelor’sdegree and five years of related experience or a combination of relevanteducation and experience.

  • Excellent communicationand organizational skills and superb attention to detail.
  • Experience with MSOffice products and database applications required.
  • Excellentinter-personal skills and customer service focus is required.
  • Experience in clinicalresearch management and oversight, including project management in a dynamicresearch setting.
  • Strong knowledge ofregulatory affairs, including FDA regulations, IRB review and approval process,and Good Clinical Practice.
  • Experience indeveloping and implementing training/education.
  • Demonstrated ability tomanage multiple projects and staff under varying time constraints.
  • Strong writing skills.
  • Frequently sit, grasplightly, use fine manipulation and perform desk-based computer tasks, lift,carry, push pull objects that weigh to ten pounds.
  • Occasionally sit, use atelephone or write by hand.
  • Rarely kneel, crawl,climb, twist, bend, stoop, squat, reach or work above shoulders, sort, filepaperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under thelaw, the University will provide reasonable accommodation to any employee witha disability who requires accommodation to perform the essential functions ofhis or her job.

  • Mayrequire occasional local and overnight travel.
  • Interpersonal Skills:Demonstrates the ability to work well with Stanford colleagues and clients andwith external organizations.
  • Promote Culture ofSafety: Demonstrates commitment to personal responsibility and value forsafety; communicates safety concerns; uses and promotes safe behaviors based ontraining and lessons learned.
  • Subject to and expectedto comply with all applicable University policies and procedures, including butnot limited to the personnel policies and other policies found in theUniversity's Administrative Guide,
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Job No:
Posted: 10/11/2020
Application Due: 12/10/2020
Work Type: