Regulatory Specialist

🔥 45 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🚫👨‍🎓 No degree required

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ObjectiveHealth

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

💰 $7M Venture Round on 2022-11

Healthcare • Consulting • Healthcare Insurance

ObjectiveHealth is a healthcare company dedicated to integrating clinical trials into standard medical practice, particularly at the point of care. Specializing in areas such as gastroenterology, dermatology, urology, oncology, and metabolism disorders, ObjectiveHealth offers a unique technological platform that facilitates patient enrollment, screening, and trial management. By partnering with physicians and community health centers, the company enhances patient access to advanced clinical trials, providing sponsors with a robust research infrastructure. ObjectiveHealth also strives to improve patient outcomes through its innovative use of electronic health records and health algorithms to find suitable patients for trials and optimize trial results.

📋 Description

• Coordinate and participate in regulatory research activities for all sites across ObjectiveHealth • Prepare, review, manage, track, file, and submit study-specific regulatory and training documents • Maintain delegation of authority and training logs, CVs, licenses, training certificates, and physician credentials • Ensure compliance with IRB-approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws • Follow up on pending signatures and missing documentation • Collaborate with internal teams, research staff, investigators, and external sponsors to resolve issues • Prepare IRB submissions, including initial protocols, amendments, and safety updates • Review and edit Informed Consent Forms for regulatory and protocol compliance • Participate in study start-up, monitoring visits, audits, and regulatory inspections • Maintain current knowledge of clinical research regulations, GCP, and FDA/ICH guidance • Provide regulatory training to site staff as needed

🎯 Requirements

• Bachelor’s degree in life sciences, healthcare, or related field (preferred) • 2+ years of experience in clinical research regulatory affairs or a similar role • Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes • Excellent organizational, communication, and documentation skills • Ability to manage multiple priorities and deadlines with strong attention to detail • Legal authorization to work in the US • Not currently accepting work visas

🏖️ Benefits

• Competitive compensation • 401(k) with Company match • A clear career pathway for advancement within the Company • Short- and Long-Term Disability • Health Savings and Flexible Spending Accounts • Health, Dental and Vision insurance Plans • Generous PTO • Adoption Assistance • Paid Holidays • A wide selection of other voluntary benefits