Clinical Trials Regulatory Specialist 2

Job description

Clinical Trials Regulatory Specialist 2🔍School of Medicine, Stanford, California, United States📁Research📅Oct 12, 2020 Post Date📅87512 Requisition #ClinicalTrials Regulatory Specialist 2

The Stanford Cancer Institute (SCI) is one of an elitemember of National Cancer Institute-Designated Comprehensive Cancer Centers inthe country, and is a prominent, dynamic, growing and complex Institute withinthe Stanford University School of Medicine. The SCI actively works to build synergies and collaborations amongfaculty with cancer-relevant expertise from four Schools and over 30departments across Stanford University. We seek a Regulatory Specialist 2 to help us enact our mission to reducecancer mortality through comprehensive programs of cancer research, treatment,education and outreach. Given the SCI’smission, breadth, and depth, it employs over 320 staff members in a fast-paced,team-oriented, and forward-thinking environment with tremendous opportunitiesfor personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of theStanford Cancer Institute since the vital work performed there enables ouradult and pediatric cancer centers to translate research from the laboratoryinto the clinical setting. You will beworking with an unparalleled leading edge community of faculty and staff whoare fundamentally changing the world of health care in the cancer arena.

ClinicalTrials Regulatory Specialist 2 will be part of the CCTO’s Regulatory team thatassists faculty and clinical research staff with regulatory submissions to theStanford University Panel on Human Subjects (known as the Institutional ReviewBoard or IRB) and the NCI Central IRB (referred to as the CIRB).

Reporting to the Manager of Regulatory Operations, theClinical Trials Regulatory Specialist 2 will be conversant in the goals,mission and priorities of the Institute, and utilize this knowledge to performjob duties. We are seeking candidateswith excellentcommunication skills and superb attention to detail. Our staff run toward challenges, and you willhave a demonstrated history of doing the same with a high degree ofprofessionalism, initiative and flexibility. Responsibilities include:

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 expertliaison in specialized compliance or scientific area between the investigatorsand regulatory agencies. Provide regulatory support, guidance, and informationto principal investigators and research staff. May consult on protocol development.
  • Develop, deliverand manage tools to facilitate education and training, prepare writtenmaterials to communicate with research community including presentations,one-on-one training and orientation sessions.
  • Oversee andmaintain regulatory documentation, safety reporting procedures and audit safetyreports to ensure they are appropriately handled.
  • Evaluate andanalyze the impact on new regulations and determine how to implement withinunit. Apply knowledge of international, federal, state and local regulations aswell as university 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 manageprojects related to regulatory activities and clinical operations, develop theregulatory strategy for project teams.
  • May hire, orient,and provide 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 assigned

DESIREDQUALIFICATIONS:

  • 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.
EDUCATION& EXPERIENCE (REQUIRED):

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

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
  • Excellentcommunication and 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 inclinical research management and oversight, including project management in adynamic research setting.
  • Strong knowledgeof regulatory affairs, including FDA regulations, IRB review and approvalprocess, and Good Clinical Practice.
  • Experience indeveloping and implementing training/education.
  • Demonstratedability to manage multiple projects and staff under varying time constraints.
  • Strong writingskills.
PHYSICAL REQUIREMENTS*:
  • 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 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, theUniversity will provide reasonable accommodation to any employee with adisability who requires accommodation to perform the essential functions of hisor her job.

WORKSTANDARDS:

  • InterpersonalSkills: Demonstrates the ability to work well with Stanford colleagues andclients and with 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 andexpected to comply with all applicable University policies and procedures,including but not limited to the personnel policies and other policies found inthe University's Administrative Guide, http://adminguide.stanford.edu.
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Job No:
Posted: 10/14/2020
Application Due: 12/13/2020
Work Type:
Salary: