We are seeking a Remote Research Regulatory Coordinator- Full Time to join our team!
Location: Remote – Candidate must be based in Nigeria
Schedule: Monday–Friday, 8:00 AM–5:00 PM U.S. Central Time (CST)
Compensation: $300–$350 USD per month
Category: Clinical Research
Overview
Gadolin Research is seeking a detail-oriented and organized Remote Research Regulatory Coordinator to join our clinical research team. This is a full-time remote position for a candidate based in Nigeria who is able to work consistently during U.S. Central Time business hours, Monday through Friday, 8:00 AM–5:00 PM CST.
The Research Regulatory Coordinator leads, coordinates, and oversees regulatory processes across multiple studies in different therapeutic areas and phases, in accordance with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols, plans, and processes.
The ideal candidate will have a minimum of a Bachelor’s degree, preferably in life sciences, nursing, healthcare administration, business administration, research administration, or a related field. Clinical research and regulatory experience is strongly preferred, but not required.
Responsibilities
• Manage regulatory activities across assigned clinical trials in accordance with applicable regulations, site SOPs, and study-specific requirements.
• Prepare, organize, and submit regulatory documents to Sponsors, CROs, and IRBs, including study start-up documents, amendments, continuing reviews, and other required submissions.
• Maintain accurate and up-to-date regulatory files, trackers, and essential documents throughout the study lifecycle.
• Maintain staff regulatory documentation, including training records, CVs, licenses, certifications, and Delegation of Authority (DoA) logs.
• Track regulatory deadlines, approvals, outstanding documents, and study requirements, and proactively follow up to ensure timely completion.
• Coordinate study start-up activities and assist with Sponsor/CRO/IRB submissions and communications.
• Serve as a point of contact between the site, Sponsors, CROs, IRBs, Investigators, and internal staff regarding regulatory matters.
• Support monitoring visits, audits, and inspections by ensuring regulatory files and required documentation are complete and readily available.
• Assist with study close-out and regulatory document archiving.
• Communicate regulatory updates and outstanding items to the Site Manager and research team and escalate issues when necessary.
• Proactively monitor outstanding regulatory tasks, follow up with team members and study stakeholders, and ensure assigned tasks are completed within required timelines.
Required Education, Experience, and Qualifications
• Bachelor’s degree preferred in nursing, life sciences, pharmacy, healthcare administration, business administration, or a related field.
• Prior regulatory experience preferred, but not required.
• Experience working with clinical trial regulatory documentation and study start-up activities is preferred.
• Must be based in Nigeria and able to work 8:00 AM–5:00 PM U.S. Central Time, Monday through Friday.
Skills
• Strong attention to detail and organizational skills.
• Ability to prioritize multiple tasks and meet deadlines.
• Ability to work independently in a remote environment while maintaining effective communication with the clinical research team.
• Strong written and verbal communication skills.
• Intermediate competency with Microsoft Word, Excel, Outlook, and internet-based systems.
• Ability to learn and work with various clinical research and regulatory platforms.
• Strong problem-solving and follow-up skills.
• Ability to maintain confidentiality and handle sensitive clinical research information appropriately.
About Gadolin Research
Gadolin Research is a dedicated, multi-therapeutic, Phase 1–4 clinical trial site located in Beaumont, Texas. Our team is committed to bringing cutting-edge clinical trials to Southeast Texas, benefiting our community, and establishing Gadolin as a clinical trial facility of choice within the industry.
Job Type: Full-time
Pay: $300–$350 USD per month
Work Location: Remote – Candidate must be based in Nigeria
Schedule: Monday–Friday, 8:00 AM–5:00 PM U.S. Central Time
Language: English (Required)
Job Type: Full-time
Pay: $300.00 - $350.00 per month
Work Location: Remote