Regulatory Start-Up Specialist

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $81,000-$82,000

Position Summary

The Regulatory Start-Up Specialist will be responsible for study start-up for designated clinical trials within the Herbert Irving Comprehensive Cancer Center Clinical Protocol and Data Management office. This position reports directly to the Regulatory Manager.

This position is located at 400 Kelby St. Fort Lee, NJ. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

• 
  GENERAL STUDY MANAGEMENT
  
  
  
  • Assist in the proper execution of the clinical research protocols.
  • Will be the lead personnel for Rapid Activation studies.
  • Manages a small subset of clinical research studies. The incumbent will ensure that all regulatory activities for clinical trials are completed in a timely and confidential manner.
  • Collaborates with the clinical team to ensure timely submission of new protocols, renewal, modifications and other regulatory functions.
  
  
  
  
• 
  STUDY START-UP
  
  
  
  • Study activation including IND submissions.
  • Work closely with the clinical team to ensure timely submission to applicable committees for new protocols.
  • Will help arrange and participate in Investigator meetings and site initiations.
  • Transfer protocol to Regulatory Coordinator after study team has been initially trained Work with external groups such as JRSC, IBC, CTO, etc., and create workflows to streamline study review and activation.
    
  
  
  
  
• 
  STUDY ACTIVATION TIMELINES
  
  
  
  • Maintain and evaluate trackers for study start-up timelines.
  • In collaboration with the Regulatory Manager and CPDM leadership develop plans and goals for study activation.
  
  
  
  
• 
  OTHER
  
  
  
  • Education, training, and ongoing supervision of pertinent staff members.
  • Incumbent will ensure that all regulatory activities for clinical trials are completed in a timely and confidential manner.
  • Participation in committee or other meetings as assigned.
  • Performs other related duties and participates in special projects as assigned.
  • Completes or contributes to a department-wide process improvement project or initiative.
  • Perform other duties as assigned.
  
  
  
  

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience, plus three years of related experience.

Preferred Qualifications

• Master's degree in management or public health.
• Oncology Clinical trials experience.

Other Requirements

• 2 years Regulatory Coordinator experience or other related experience.
• Excellent interpersonal and organizational skills.
• Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.