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Research Compliance Support Manager
Key Solutions, Inc.
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Research Compliance Support Manager

Key Solutions, Inc.

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Details
Posted:
February 7, 2019
Location:
Fremont, California
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Salary:
Type:
Full Time - Experienced
Discipline:
Academic / Research

Company Background

Key Solutions Inc. is the leader in providing integrated, comprehensive software products and services to universities, hospitals, pharmaceutical companies, biotech firms, government facilities and independent institutes worldwide. Our solutions streamline and automate Research Administration and Compliance processes, Grants Management, and Conflict of Interest Management for our customers. Founded and based in Silicon Valley, Key Solutions continuously strives to advance discovery as an effective partner to the Life Science and Research communities. 

www.keyusa.com

Position Summary

If you have experience with regulatory compliance and 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, and have excellent customer service skills, you may be the right match for this position. We are looking for someone to build and lead our Research Compliance Support team.

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 advanced 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 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 application to perform regulatory committee reviews of human subjects 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 investigators
  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 numberof 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 them 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:                                 

Required

  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 compliance related field, or as a 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. Abilityto 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. Domain knowledge related to clinical research and research compliance in academic, pharmaceutical,and hospital environments is a plus.
  3. Experience managing a software product customer support team
  4. Experience with software applications in the health or life sciences is a plus
  5. 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.

Internal Number: RCSM-022019
About Key Solutions, Inc.
Key Solutions Inc. is the leader in providing integrated, comprehensive software products and services to universities, hospitals, pharmaceutical companies, biotech firms, government facilities and independent institutes worldwide. Our solutions streamline and automate Research Administration and Compliance processes, Grants Management, and Conflict of Interest Management for our customers. Founded and based in Silicon Valley, Key Solutions continuously strives to advance discovery as an effective partner to the Life Science and research communities.
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