Kelly Scientific Resources has a great direct hire opportunity for a Director of IRB Operations in Needham, MA to provide 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.
- 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 the Operations team:
- Lead team to ensure goals and objectives are met or exceeded.
- Obtain 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 and 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 in 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, 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.
- 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.
- Must have at least 5 years’ experience in a successful position leading a team to achieve company goals.
- Experience in clinical research or IRB setting with evidence of increasing responsibility highly preferred.
- Certified IRB Professional (CIP) preferred.
- Knowledge of FDA Code of Federal Regulations (21 CFR Parts 50, 11, 56, 312, and 812 and 45 CFR) and ICH Guidelines required.
- 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.
- As a change agent, the ability to build morale and group commitments to goals and objectives is required.
- Must be results oriented and do what is necessary to improve performance; balances the resources necessary to produce desired outcomes; tracks and monitors performance.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.