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Director of IRB Operations

New England IRB


Location:
Needham Heights, Massachusetts 02494
Date:
08/11/2017
2017-08-112017-09-10
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Business Development/Operations
New England IRB
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Job Details

Founded in 1988, New England Independent Review Board (New England IRB) was one of the first independent IRBs established to meet the review needs of sponsors, contract research organizations, and investigators across the United States. New England IRB provides a strong regional presence for high-quality, full-service, independent review in the clinical trial industry. For studies ranging from one site to several thousand and spanning all phases of research, New England IRB is the definition of innovation and clinical research leadership in the Northeast corridor.

Position Summary:

The Director of IRB Operations position provides leadership and guidance to Operations teams responsible for initial new study and investigator submissions, and outcome decision communication.  This position will oversee the employees and the processes to ensure all systems are in place to protect the rights and welfare of human subjects involved in clinical research.

Essential Duties/Responsibilities:

  • Provide overall direction for departments that offer client support through all phases of study lifecycle. 
  • Work in playing a vital role in the company’s vision and business direction.  This should include working closely with appropriate leaders to ensure compliance throughout the team.
  • Direct activities of Operations team:  
    • Lead team to ensure goals and objectives are met or exceeded.
    • Responsible for obtaining desired results from all personnel. 
    • Ensure policies and procedures are followed by all operations staff.
    • Implement training and performance action plans as well as handle personnel issues including discipline.
  • Establish and maintain open line of communication with existing clients soliciting real time feedback on overall company performance relaying their issues and/or concerns to appropriate staff to ensure effective resolution and to exceed expectations.
  • In conjunction with the Institutional Official, manage all operational requirements for IRB Board members and alternate Board Committees. 
  • Provide superior customer service to all clients with inquiries, issues or needs. Lead the client service teams toward technological advancing methods of processing study related information and communicating with clients.  Use professional judgment handling escalated issues of heightened importance presented by team leaders, Client Relations or Business Development.
  • Develop department processes to maintain quality and create efficiencies to ensure deadlines are met. This includes participating in the development and review of departmental Standard Operating Procedures (SOPs) and intra-departmental procedures.
  • Responsible for expediting the delivery of clinical trial documents to clients including adherence to timelines, customer service goals, etc.
  • Develop and manage existing clients by offering a personal touch through periodic face to face interaction and point of contact to exceed expectation of client base to eventually attain growth via referrals.
  • Work closely with Business Development department with metrics and utilizing that information to ensure client promises are upheld.
  • Responsible for establishment of and adherence to Operations’ budgets. Monitor project status, budget expenditures, and identify problems and recommend solutions.
  • Monitor department metrics and utilize data to increase productivity and service. 
  • Stay abreast of changes in FDA and OHRP regulations and company-wide processes so as to be a reliable resource to clients.

Requirements

Education Requirements:

  • Bachelor’s degree or equivalent experience required.
  • Must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB.  Must maintain CIP certification. 

Qualifications/Experience Requirements:

  • Must have at least 5 years’ experience in successful position leading a team to achieve company goals.  
  • Ten years’ experience in clinical research or IRB setting with evidence of increasing responsibility highly preferred.  
  • Certified IRB Professional (CIP) strongly preferred. 
  • Advanced problem solving and negotiating skills required.  
  • Knowledge of FDA Code of Federal Regulations (21 CFR Parts 50, 11, 56, 312, and 812 and 45 CFR) and ICH Guidelines required.  
  • Must be conversant with applicable regulations and industry standards governing clinical research and project/clinical trial management.  
  • Advanced skills in Microsoft Word, Excel, Outlook, and the development as well as deliverance of Power Point presentations required. 
  • Demonstrate effective leadership skills and serve as a role model for others; is able to translate strategy into meaningful actions within the team. 
  • Strength in relationship building throughout the business with the ability to build support at all levels. 
  • As a change agent, the ability to build morale and group commitments to goals and objectives is required.  
  • Results oriented and do what is necessary to improve performance; balances the resources necessary to produce desired outcomes; tracks and monitors performance. 
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