Regulatory Specialist
Company Overview
At Dermatologists of Central States (DOCS), we are not just one of the largest dermatology practices in the nation; we are a dedicated community passionate about skin health! With more than 200 providers across 20 practice brands and 100+ locations in 10 states, we’ve been transforming the lives of our patients for more than 40 years. Our mission is clear: to prioritize our patients with outstanding medical, surgical, and cosmetic dermatology services, all delivered in a friendly, convenient, and compassionate environment.
Summary
We are looking for a Regulatory Specialist to provide support to our clinical research team and subjects. This role ensures regulatory compliance for clinical research studies in accordance with the standards of Good Clinical Practice, HIPAA. and OSHA.
Job Responsibilities
- Maintain a professional and courteous manner (verbal, written and in appearance) when interacting with staff, sponsors, IRBs, and subjects.
- Make moral and ethical decisions during interaction with patients, sponsor and IRB representatives, physicians and other staff.
- Independently manage workflows.
- Maintain ongoing communication with Director of Research, Research Manager, Principal Investigator/Sub-Investigator, other study personnel and sponsor/CRO per SOPs and as deemed necessary.
- Possesses a thorough understanding of the study protocol(s) to answer all questions pertaining to the study posed by monitors or other staff members.
- Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements between sponsors and other entities.
- Collect and coordinate information and prepare regulatory documentation for submission to IRBs.
- Perform archiving and destruction of records in compliance with regulatory requirements. as well as assisting in the final close-out storage of clinical trial records.
- Participate in educational training seminars on all topics of clinical research.
- Maintain updated CV's and "Clinical Trial Experience'' data sheets.
- Prepare for monitoring visits and assist with regulatory issues during the visits.
- Assist in required contract invoicing of trial budgets. Request checks for patient compensation.
- Track and control submissions to IRB (Investigational Review Board).
- Follow and maintain GCP in the regulatory processes.
- Maintain regulatory binders for all studies.
- Meet with monitor during visits to review the Regulatory Binder.
- Comply with all HIPAA regulations.
- Perform all duties in a safe and prudent manner.
- Promptly report adverse events to Associate Director of Research, Principal Investigator/Sub-Investigator, sponsor/CRO as deemed necessary and to ensure subject safety.
- Responds to monitor notes and/or emails in a timely manner.
- Assist with maintenance of the clinical trial advertising/recruitment database and telephone communication for scheduling and follow up appointments as needed.
- Other duties as assigned.
Benefits
- Our benefits package includes medical, dental, and vision insurance, 401k matching, company paid life insurance, employee assistance program, and paid time off.
Minimum Qualifications
- High School diploma or equivalent certification.
- 3 years of clinical trials experience, as well as an understanding of clinical trials rules and regulations.
- 3 Years of experience in a medical office.
- Ability to learn tasks related to the operation of the facility and assist physicians.
- Thorough understanding of HIPAA.
- Knowledge of ICD-10 and CPI coding, and ModMed EMA EMR, preferred.
- Ability to maintain strictest confidentiality.
- Ability to prioritize tasks quickly and appropriately.
- Ability to multi-task.
- Meticulous attention to detail.
- Strong organizational skills.
Equal Opportunity Employer: Race. Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status
