Position Summary

We are looking for someone with excellent customer service skills and experience in research regulatory compliance, specifically with review boards: institutional review boards (IRBs), Institutional Animal Care and Use Committees (IACUCs) and/or Institutional Biosafety Committees (IBCs); or working in a sponsored projects office with pre-award and post-award grants and contracts. We are looking for someone to build and lead our Research Compliance Application Support team.

In this position, you will work with an outstanding team to provide an exceptional experience for top research organizations across the country. With your understanding of the world of Research Compliance, its challenges, and what it takes for someone in this area to succeed; you can help our customers solve their problems and help them get the most out of the Key Solutions’ applications.

You have the opportunity to use your research regulatory knowledge and experience to build a team of “go to” people to help our customers succeed. You will be in a position to innovate in order to dramatically improve our customer’s support experience and help us become a leader in proactive customer support. This is a supervisory position. You and members of your team work closely with our Customer Experience and Success organization and the Engineering and Quality Assurance organizations to facilitate understanding, isolating, and resolving problems in a timely fashion, plus identifying measures that can be taken to prevent future problems. Opportunities for impact range from minor changes to the introduction of new approaches.

Major Responsibilities:

1. Leverage your knowledge of regulatory compliance to help customers use the Key Solutions applications to analyze protocols and supporting documents to ensure conformance with all applicable regulations, statutes, policies, and procedures
2. Aid customers in using the Key Solutions software applications to perform regulatory committee reviews of human subject and animal subject protocols, including management of Institutional Review Board (IRB) committee, Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC), along with other regulatory committee functions, such as creation of agendas, minutes, memos, and other documentation for reviewer, investigators, and committee staff
3. Help customers use the application to communicate with investigators and assist research staff with study preparation
4. Identify and share best practices with respect to pre-award grant preparation and submission; post-award tracking and reporting; protocol creation and processing, including reviewing regulatory or mandated compliance requirements, and reporting
5. Build upon established processes, procedures, and escalation mechanisms for resolving customer issues in a timely manner with a minimal number of interactions while exceeding customer expectations
6. Develop and maintain strong working relationships with cross-functional partners to coordinate and facilitate customer focused activities
7. Establish and maintain strong and cordial customer relationships while collaborating with customers to work through issues
8. Coordinate software installation, configuration, and customization with other parts of the company
9. Ensure frequent follow-up with customers with status updates until resolution is reached
10. Proactively stay up-to-date with the latest trends concerning regulatory changes, the company’s products, and the underlying technologies
11. Recommend corrective and preventive actions to improve customer satisfaction and customer experience with Key Solutions products
12. Recommend new features and functionalities based on customer interactions
13. Assist Quality Assurance with testing program changes, new releases, and user documentation
14. Participate in the development of training materials and the training of customers.
15. Work across multiple time zones with remote team members
16. Learn about Key Solutions applications and work with the support team to improve overall customer use and satisfaction with Key Solutions applications
17. Orient new staff; build a team; delegate tasks and projects; monitor the timely and accurate completion of work; mentor and manage staff; conduct performance appraisals; help team members close gaps in performance
18. Be a hands-on manager building and assisting the team to provide application support for customers via telephone, email, web portal, and web conferencing

Qualifications

1. Bachelor’s degree and three years of relevant experience, or combination of education and relevant experience.
2. Two years of professional experience in a research compliance related field, or as a research compliance professional.
3. A minimum of 3 years of customer and technical support with demonstrated problem resolution skills.
4. Excellent customer service skills and ability to use tact and discretion.
5. Comprehensive knowledge of regulations and ethical principles regarding human and animal subjects in research.
6. Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management.
7. In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
8. Strong knowledge of grants and contracts function.
9. Demonstrated strong verbal and written communication skills.
10. A passion for taking care of customers and delivering excellent customer support.
11. Experience with software applications, including proficiency in Microsoft tools (Outlook, Word, Excel, & PowerPoint).
12. Ability to thrive in a fast-paced environment.
13. Ability to understand and articulate technical concepts and drive solutions.
14. Ability to work with remote team members.
15. Experience hiring, managing, and motivating staff; effectively managing the completion of a high volume of work, some of which is cyclical.
16. Ability to work a flexible schedule, including the ability to participate in an on-call rotation, which includes nights, weekends and holidays.

Desired

1. Certified IRB Professional (CIP) is a major plus.
2. Experience in sponsored projects office working with research teams on pre-award grant preparation and submission; post-award tracking and reporting; protocol creation and processing is a major plus.
3. Domain knowledge related to clinical research and research compliance in academic, pharmaceutical, and hospital environments is a plus.
4. Experience managing a software product customer support team is a plus.
5. Experience with software applications in the health or life sciences is a plus.
6. Experience providing structured training (internal and external) is a plus.

EEO Employer/Vet/Disabled

Key Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

Application Submission

"We are one of the leading Clinical Research Software and Services provider, built on innovation and commitment to customers success. If you are a hunter and have a proven track record from lead generation to sell to C level and Senior Executives, this is the position that would help you to achieve your full potential."

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