Regulatory Associate - Department Of Ophthalmology

The Department of Ophthalmology at West Virginia University is currently accepting applications for a Regulatory Associate.

About the Opportunity

This position examines, evaluates, and investigates conformity with the regulatory aspects of industry and government sponsored clinical trials and investigator initialized clinical research. This includes securing Institutional Review Board (IRB) approval and maintaining all records pertaining to IRB approval and oversight. Performs various duties, such as research, analysis and auditing in support of project IRB submissions to assure compliance. This position provides program, as well as direct internal and external client support services. Responds to inquiries and independently resolves matters of low to moderate complexity. Responsibilities require some judgment, resourcefulness, and originality, but diverse guides and precedents are usually available to apply or adapt to the circumstances. Work effort has considerable impact on client services, program and project image, with potential legal liabilities.

We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 18 sick days per year (for when you're ill, for when you need time to care for sick family, for your own, or your family's, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ's.
• Wellness programs

What You'll Do

• Responsible for completing all regulatory activities associated with active industry and cooperative group sponsored clinical studies

• Start-up tasks of sponsored clinical studies

• Plans and writes materials required for IRB submissions

• Submits new protocols to WVU IRB for local review and acknowledgement

• Reviews and reconciles regulatory files with sponsor monitors

• Prepares and submits IRB continuing reviews and amendment reviews

• Updates protocol specific documents including FDA Form 1572, Financial Disclosure Forms, Delegation Logs, and Training Logs as needed

• Responds to questions regarding regulatory issues

• Submit appropriate documents to close or suspend study protocols

• Coordinates and attends study closeout visits

• Prepares for study monitoring and auditing visits by reviewing all protocol specific regulatory files and reconciling as needed. Notifies appropriate institutional officials of external audits by FDA and sponsors

• Reviews and reconciles regulatory files with sponsor monitors

• Maintains professional and prompt communications with investigators, coordinators, and sponsors as required

• Responds to questions regarding regulatory issues, including queries from internal quality review

• Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standards

• Participates in networking opportunities, and continuing education

• Bachelor's degree in an allied health discipline or related field.

• A minimum of two (2) years of experience in the following:

• Working in a clinical setting and/or experience working in clinical trials.

• Any equivalent combination of related education and/or experience will be considered

• All qualifications must be met by the time of employment.

Knowledge, Skills and Abilities

• Strong desire to learn, seek out and apply new knowledge, methods and information
• Working knowledge of regulatory aspects of industry and government sponsored clinical trials. Including IRB regulations.
• Skilled at problem solving.
• Excellent teamwork skills.
• Basic work processing skills and understanding and the ability to handle stress and work under pressure.
• Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions. conclusions or approaches to problems.
• Strong time management skills.
• Computer proficiency, including Microsoft Office.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to manage multiple projects and changing priorities is required.
• Demonstrated ability to work effectively in both cross-functional teams and independently is required.
• Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors: and others
• Ability to manage multiple projects and changing priorities
• Highly resourceful team player, with the ability to also be effective, independent, interact professionally, and utilize effective writing and organizational skills.
• Proven ability to handle confidential information with discretion

Preferred Qualifications

• Master's degree is preferred.