Regulatory Start-Up Specialist at Equity Medical | Torre
Regulatory Start-Up Specialist
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Equity Medical

Regulatory Start-Up Specialist

Equity Medical
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Emma
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You'll accelerate innovative treatment options for underserved communities through compliant clinical trial activation.
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Freelance
Recurrent
Compensation
USD2.33k - 2.91k/month
Non-negotiable
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Remote (for Philippines residents)
Remote (for Dominican Republic residents)
Remote (for Mexico residents)
Remote (for Argentina residents)
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Posted 25 days ago

Requirements and responsibilities

About Equity Medical: Equity Medical is a rapidly growing multi-site clinical research organization conducting trials across a variety of therapeutic areas including dermatology, allergy/immunology, respiratory, rheumatology, neurology, and metabolic diseases. Our mission is to bring innovative treatment options to underserved communities through high-quality, compliant, and efficient clinical trial operations. We are seeking a highly organized and experienced Regulatory Start-Up Specialist to support study start-up activities across multiple U.S.-based research sites. This role is ideal for someone with strong knowledge of U.S. clinical trial regulations, IRB submissions, and sponsor/CRO start-up requirements. Position Summary: The Clinical Research Regulatory Start-Up Specialist will be responsible for coordinating and executing study start-up and regulatory activation activities from feasibility through site activation. This individual will work closely with internal operations, investigators, sponsors, CROs, and IRBs to ensure all essential documents and submissions are completed accurately and on time. This position is remote and may require overlap with U.S. Eastern Time business hours. Key Responsibilities: - Prepare, review, and maintain regulatory/start-up documents for new clinical trials. - Prepare and submit packages to central and local IRBs. - Collect and track essential regulatory documents, including: - Investigator CVs. - Medical licenses. - GCP certificates. - Lab certifications. - Financial disclosure forms. - FDA Form 1572s. - Maintain study start-up trackers and activation timelines. - Assist with sponsor feasibility questionnaires and site qualification documentation. - Upload and maintain documents in sponsor/CRO portals (e.g., Veeva, Florence, SIP, Complion, etc.). - Coordinate with internal site teams to ensure timely completion of activation requirements. - Assist in preparing site regulatory binders/eReg files. - Support CTA/budget collection and internal routing as needed. - Ensure all documentation is inspection-ready and compliant with ICH-GCP, FDA, and company SOPs. - Escalate delays or missing documentation proactively. Qualifications: Required: - 2+ years of experience in clinical research regulatory/start-up or study activation. - Strong knowledge of: - ICH-GCP guidelines. - FDA regulations. - IRB submission processes. - Essential regulatory documentation. - Experience working with sponsors/CROs in the U.S. clinical trial market. - Strong English written and verbal communication skills. - Excellent organizational and project management skills. - Ability to manage multiple studies and deadlines simultaneously. - High attention to detail and ability to work independently. Preferred: - Experience in dermatology, allergy/immunology, respiratory, or multi-therapeutic research. - Experience with eRegulatory systems and sponsor portals. - Experience supporting U.S.-based research sites remotely. - Bachelor’s degree in life sciences, healthcare, or related field. Schedule / Compensation: - Flexible remote schedule, with some required overlap with U.S. Eastern Time hours. - Full-time or contractor arrangement available. - Competitive compensation based on experience and location. Why Join Us?: - Work with a fast-growing U.S.-based clinical research organization. - Opportunity to support cutting-edge clinical trials and innovative therapies. - Flexible remote work environment. - Growth opportunities within a rapidly expanding site network.
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