Audit Coordinator at Florence Healthcare (Atlanta, GA)
What We Do:
Florence (florencehc.com) software reduces the time it takes to deliver medical cures to those who need them. Our industry-leading software is used to streamline clinical trials at over 10,000 research sites, sponsors, and CROs across 44 countries.
Florence was recognized as the Biggest Impact Company, a Top 10 Innovative Company in Georgia by the Technology Association of Georgia in 2021, and most recently No. 31 on the Fortune list of Best Small Workplaces 2021.
What You’ll Bring to The Team:
The Florence Compliance Team is looking for an Audit Coordinator who is passionate about clinical trials to advance cures. To be successful, you must be comfortable with multi-tasking, streamlining processes, educating others, and challenging the status quo in a regulated yet continuously evolving and innovative environment. This role reports to the Compliance Audit Manager and provides the Compliance Team with project management support during audits, policy and procedure development, and any other multifaceted activity.
- Audit Readiness: Partner with all internal teams to evaluate audit readiness and preparedness prior to all internal, external, and accreditation audits.
- Triage SME Correspondence: Triage incoming audit and compliance-related inquiries and requests (internal and external) to the appropriate teams and subject matter expert (SME). Conduct trend analyses to identify continuous improvement opportunities.
- Audit Preparation: Support our team’s Audit Manager in partnership with the Sales and Strategic Accounts Teams to ensure that compliance materials are available prior, during, and after external audits.
- Audit Retrospectives: Lead and manage post-audit retrospective sessions with appropriate stakeholders. Partner with the Audit Manager to prepare and deliver post-audit remediation messaging and updates for the company and executive/board.
- Internal Audit Oversight: Support our team’s Audit Manager and Policy Manager to coordinate the schedule of events of recurring compliance needs to drive audit readiness (e.g., application renewals, effectiveness checks, access checks, audit/artifact expirations, vendor oversight, PnP updates, etc.).
- Privacy - DSAR Fulfillment: Support our Privacy Team with incoming data subject access requests (DSAR) in partnership with the Access Control Team to ensure compliance and completion.
- Internal Audits: Support our team’s Audit Manager in partnership with our Risk and Quality Teams to maintain risk-based criteria and checklists.
- Industry Trends and Updates: Stay current with relevant industry trends and news updates related to compliance and project management by attending relevant industry conferences, training, and/or classes.
- Marketing: Partner with Marketing Team to have a voice regarding the evolution of eClinical software quality audits
- Improvement Projects: Collaborate with the Florence Compliance Team on various projects to improve and innovate
We’ll Be Successful Together if You Have:
- 3 years of relevant experience in audit/project management or coordination, preferably in a regulated industry (e.g., pharmaceutical, medical device) and/or SaaS company
- Project management or process improvement certification: ASQ Six Sigma or an equivalent
- Interested in or actively pursuing the Certified Internal Auditor (CIA) designation
- Experience with operational audits, SOC 2 audits, and/or SOX/MAR testing
- Understanding of internal controls
- Excellent analytical and problem solving skills
- Interested in continuous improvement and ways to minimize redundancy
- Comfortable working independently, challenging the status quo, and meeting deadlines
- Familiarity with (and/or willingness to receive training and education) compliance requirements:
- Regulations (e.g., US FDA 21 CFR Part 11, EU EMA, UK MHRA, etc.)
- Data Protection (e.g., EU GDPR, US HIPAA, US CCPA, etc.)
- Basics (e.g., confidentiality, ethics, conflict of interest, bribery, etc.)
- Compliance at Florence (e.g., SDLC, Quality, Risk, Regulations)
What’s in it for you?
- Do well. We offer exceptional salary, fun remote activities, the PC setup of your choice and office space(remote currently due to COVID) in the heart of Atlanta, as well as medical and dental insurance.
- Do good. We insist that health technology is the highest calling for software development. We pride ourselves on working on something bigger than ourselves; helping advance cures and therapies
- Enjoy. Our office is in Midtown (we are currently remote due to COVID)
Florence Healthcare supports workplace diversity and does not discriminate on the basis of race, color, religion, gender identity or expression, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, physical disability, or any other protected class.