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Salary*****Please note we are only able to hire candidates living in the following states: ******
NY, PA, NC, GA, AZ, FL or VT
About Atlas
Atlas Clinical Research is a leading Private Equity (PE)-backed Clinical Research site network, dedicated to transforming the healthcare landscape through innovative research solutions. We envision a world where patients and their families have ready access to groundbreaking new treatments being developed by our sponsors, and made possible through the access, care, and support provided by our therapeutically-focused clinical network.
Job Summary
Under the direction of the Regulatory Manager, the Regulatory Specialist will be responsible for processing regulatory packets and documents for clinical trials, maintaining regulatory files across electronic platforms within the network, and facilitating Institutional Review Board (IRB) submissions.
Key Responsibilities
Document Completion and Tracking: Prepare regulatory documents for new study submissions to the IRB and sponsor. Track the status of new submissions and inform site clinical operations of relevant updates for study activation planning. Review Informed Consent Form (ICF) drafts and incorporate suggested revisions in alignment with site clinical operations, the IRB, and sponsor.
Maintenance of Regulatory Documents: Maintain regulatory files in an ?audit-ready? status at all times by ensuring documentation and filings are up to date, including updates of applicable forms with personnel changes communicated by the site. Track and process updates for critical regulatory items such as Protocol Amendments, ICF updates, and Investigator's Brochure updates. Set up appropriate training logs for updated documents. Maintain documentation of staff credentials and qualifications (e.g., CVs, licenses, GCP) and facilitate updates and / or renewal as required.
Institutional Review Board (IRB) Processing: Handle the complete cycle of IRB documents for all protocols, including submissions, processing, and tracking. Manage IRB submissions, Serious Adverse Effect (SAE) submissions, Protocol Deviation submissions, Continuing Reviews, ICF site change requests, and more according to protocol and IRB requirements. Oversee Institutional Biosafety Committee (IBC) submissions, reviews, and closeout procedures. Ensure all regulatory folders are updated at final closeout visit and notify the IRB of closure.
Collaboration and Coordination: Collaborate with the Marketing team to integrate screen tools and advertisement packets with initial IRB submissions. Attend IBC and Site Initiation Visit (SIV) meetings as the designated regulatory contact, as applicable. Distribute updated IRB Rosters as necessary. Perform ad-hoc projects and/or general office duties as requested.
Electronic Documentation Management: Establish and maintain electronic study folders for the secure storage and retrieval of all mentioned documents using e-Regulatory Systems. Ensure that the Clinical Trial Management System (CTMS) maintains accurate and complete protocol and regulatory status information.
Quality Assurance and Audits: Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
Qualifications
Associate?s Degree or higher in related field or relevant work experience.
Previous Clinical Research and regulatory experience is preferred.
Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills.
Ability to prioritize tasks and to delegate them when appropriate.
A roll-up-your-sleeves mentality and exceptional hands-on skills.
Ability to work prolonged periods of sitting at a desk and working on a computer.
Wage/Salary: $65-68K
