Clinical Research Regulatory Coordinator
24 hours ago
About Stryde Research We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey. We serve 1.5M+ patients through 100+ specialized clinics with deep expertise in dermatology, rheumatology, cardiology, and general medicine. We're scaling fast—going from 22 to 35+ team members in 2026—and need someone who can keep our regulatory house in order across multiple sites and studies. What You'll Actually Do Prepare and submit IRB applications, amendments, continuing reviews, and reportable events for multiple sites Maintain essential documents: 1572s, delegation logs, training logs, investigator CVs, medical licenses, financial disclosures Track and manage IRB approvals, renewals, and expiration dates across 15+ active studies Coordinate regulatory submissions with sponsors, CROs, and site teams—chase missing documents and keep timelines on track Ensure sites maintain current regulatory binders (paper and electronic) that are audit-ready at all times Manage protocol deviations: documentation, root cause analysis, CAPA implementation, and sponsor reporting Track site training completion and maintain training files per GCP requirements Prepare sites for sponsor audits and FDA inspections—conduct regulatory readiness reviews Communicate regulatory requirements and changes to site coordinators and PIs Support new site initiations: gather essential documents, IRB submissions, and regulatory activation You're the Right Fit If: 2+ years in clinical research regulatory role with multi-site experience Solid understanding of FDA regulations (21 CFR Parts 50, 56, 312), ICH-GCP, and IRB requirements Experience with central and local IRBs (Advarra, WCG, Sterling, Schulman preferred) Comfortable managing competing deadlines across multiple studies and therapeutic areas Detail-oriented enough to catch missing signatures or expired licenses before they become findings Can work independently and proactively—you don't wait to be told what needs renewal in 30 days What Makes You Stand Out: Experience with dermatology, rheumatology, or cardiology trials Background working with SMOs or site networks (you understand coordinating across multiple locations) Familiarity with eTMF systems (Veeva, Florence, Masterfile, or similar) CCRP or ACRP certification showing you're serious about the profession You've supported successful FDA inspections and know what regulators actually look for The Reality Check: This is remote but requires overlap with US business hours for sponsor calls, IRB correspondence, and site coordination. Some weeks you're submitting 5 different IRB amendments. Other weeks you're prepping 3 sites for audits while tracking down expired medical licenses. You'll work across time zones with site teams who are busy with patients and study visits—your job is to make regulatory compliance as painless as possible for them. When a site coordinator emails you at 8pm their time because they just realized an IRB approval expires tomorrow, you need to know exactly what emergency procedures to follow. When a sponsor changes a protocol mid-study, you're coordinating amendments across multiple IRBs with different submission requirements. Compensation & Growth: Competitive salary based on experience. Fully remote from India with flexibility but requires availability during US business hours for critical coordination.
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Clinical Research Regulatory Coordinator
10 hours ago
India Stryde Research Full timeAbout Stryde Research We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey. We serve 1.5M+ patients through 100+ specialized clinics with deep expertise in dermatology, rheumatology, cardiology, and general medicine. We're scaling fast—going from 22 to 35+ team...
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Clinical Research Regulatory Coordinator
9 hours ago
india Stryde Research Full timeAbout Stryde ResearchWe're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey. We serve 1.5M+ patients through 100+ specialized clinics with deep expertise in dermatology, rheumatology, cardiology, and general medicine. We're scaling fast—going from 22 to 35+ team...
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Clinical Research Regulatory Coordinator
14 hours ago
India Stryde Research Full timeAbout Stryde ResearchWe're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey. We serve 1.5M+ patients through 100+ specialized clinics with deep expertise in dermatology, rheumatology, cardiology, and general medicine. We're scaling fast—going from 22 to 35+ team...
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Senior Clinical Research Associate
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Bengaluru, India MS CLINICAL RESEARCH Full timeJob Description Job Title: Senior Clinical Research Associate (Sr. CRA) Company: MS Clinical Research Pvt Ltd Experience: Minimum 5 years About Us MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global...
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▷ Only 24h Left! Logistics
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India MS CLINICAL RESEARCH Full timeJob Description: Logistics & Customs Clearance Specialist Location: Bengaluru Employment Type: Full-Time Experience Level: Ex- Customs Officer/ 2-4 years of Experience Industry: Logistics / Import-Export About Us: MS Clinical Research Pvt Ltd (MSCR) is a pioneering clinical research organization committed to advancing healthcare and life sciences through...
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Clinical Research Trainer
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Trainee Clinical Research Coordinator
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India Infoclin Consultancy Full time**Job Role**: Clinical Research **Payroll**- Direct **Knowledge part**: Thorough knowledge of ICH - GCP, New Drugs and Clinical Trials rule 2019 and updating self from time to time on Regulatory and process changes (if any). Action part: P.I. Coordination, Patients screening, randomization, source documentation, site master file maintenance, eCRF entry,...
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Clinical Research Coordinator
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India, Azamgarh Seema Hospital and Eva Fertility Clinic & IVF Center Full timeJob Description Job Responsibilities - Recruit and enrol study participants - Input clinical research data into electronic data systems - Coordinate patient visits and procedures related to research - Act as a resource for study participants by answering questions and explaining related procedures - Ensure the study site complies with all local and federal...
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Clinical Trial Physician
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Senior Manager
2 days ago
Gurugram, India Transformative Ventures Full timeJob Description Job Summary: The Manager of Clinical Research will lead and manage clinical trials and research studies, ensuring that they are completed on time, within budget, and in compliance with regulatory standards. The manager will supervise research teams, collaborate with cross-functional departments, and provide strategic direction for clinical...
