• Under the direction of the Regulatory Affairs Specialist, plans, organizes, coordinates and evaluates all regulatory activities, including the design and process for collection of FDA-required data from sponsors and collaborating with external sponsors to comply with sponsor requirements.
• Consults with principal investigator(s) and clinical staff to facilitate the needs of the sponsor and their representatives and to maintain current curriculum vitae, licenses, and certifications to accompany regulatory submissions.
• Compiles the required FDA documentation for each study.
• Works independently to accurately prepare and maintain study documentation, insuring consistency with FDA guidelines and sponsor requirements; and under the direction of the Regulatory Affairs Specialist, follows through with any FDA and sponsor required documentation and/or audits. Obtains signatures on regulatory documents, follows up to assure that all are signed and submitted in a timely manner.
• Works with sponsor to bring files into consistency for close-of-study activities.
• Coordinates the required documentation for submission to Central IRBs as requested by sponsors.
• Under direction of the Regulatory Affairs Specialist, serves as a regulatory affairs resource to help formulate responses to the Sponsor/FDA/IRB/Management.
• Coordinates the process of new IRB submissions to the medical staff office, progress of and changes to ongoing research, adverse events, and IND safety reports.
• Follows rules and regulations governing adverse event issue reporting, obligations of investigator, informed consent process and elements, IRB regulations and review, patient recruitment, protocol amendments, and HIPAA regulations.
• Processes and distributes all incoming regulatory documents.
• Attends required meetings and participates appropriately in the exchange of ideas that contribute to quality of research.
• May perform other duties as assigned or requested.

• Associates degree required.
• Bachelors degree (BA) from four-year college or university in business related field strongly preferred with two years related experience and/or training required.
• Extensive experience in regulatory compliance may be considered in lieu of Bachelors degree.

• A personal presence which is characterized by a sense of honesty, integrity and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals and values of Via Christi Health.

• Proficient in Microsoft Office applications, such as Word, Excel, and Access.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to calculate figures and to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram.

• Certified IRB Manager (CIM), or equivalent certification, is preferred but not required.

• While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

• The noise level in the work environment is usually moderate.

• This position is responsible for improving patient care/patient safety, improving customer satisfaction, and supporting physicians.

Via Christi Health is an Equal Opportunity (EOE) and Affirmative Action Employer. We support diversity in the workplace.

Applicants with a disability that are in need of an accommodation to complete the Via Christi Health application process, contact the HR Customer Service Center at 1-877-389-8864 or e-mail THIS EMAIL . The hearing impaired may contact Via Christi by calling the Kansas Relay Center at 1-800-766-3777.