Clinical Trials Regulatory Specialist 2
- Employer
- Stanford University
- Location
- School of Medicine, Stanford, California, United States
View more
- Institution Type
- Four-Year Institution
Job Details
- 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.
- 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.
- 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.
- 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.
- 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.
- Schedule: Full-time
- Job Code: 4942
- Employee Status: Regular
- Grade: I
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 87512
Organization
Change the world. And yourself.
Stanford University has changed the world, over and over again.
We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.
At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment.
Stanford Facts at a Glance
Opened 1891
Student Enrollment
- Undergraduates: 6,980
- Graduates: 8,897
Campus
- 8,180 contiguous acres in six governmental jurisdictions
- Nearly 700 major buildings
- 97% of undergraduates live on campus
Research
- 5,300 externally sponsored projects
- $1.33 billion total budget
Faculty
- 2,043 faculty members
- 21 Nobel laureates are currently members of the Stanford community
- 5:1 student to faculty ratio
Stanford University is an Equal Employment Opportunity and Affirmative Action Employer and is committed to recruiting and hiring qualified women, minorities, protected veterans and persons with disabilities.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert