Job Title: Clinical Research Regulatory Coordinator (Remote – India)
Summary:
Stryde Research, a rapidly expanding Site Management Organization (SMO) with over 20 sites across the US, is seeking a highly motivated and detail-oriented Clinical Research Regulatory Coordinator to join our dynamic team. This is a fully remote, full-time position based in India, offering an excellent opportunity to advance your career in clinical regulatory affairs. As a key member of our team, you will be responsible for supporting multi-site regulatory operations, IRB submissions, and ensuring compliance documentation across our active clinical studies. If you possess a strong understanding of ICH-GCP guidelines, hands-on experience with IRB documentation, 1572s, regulatory binders, and multi-site clinical trial coordination, we encourage you to apply!
About Stryde Research:
Stryde Research is committed to accelerating clinical research and bringing innovative therapies to patients faster. We are a growing SMO dedicated to providing exceptional support to our research sites, sponsors, and ultimately, the patients we serve. We offer a collaborative and rewarding work environment where employees can grow professionally and contribute to meaningful advancements in healthcare.
Key Responsibilities:
As a Clinical Research Regulatory Coordinator, your responsibilities will include:
- IRB Submissions: Prepare and submit IRB applications, amendments, continuing reviews, and reportable events to both central and local IRBs.
- Essential Document Management: Maintain comprehensive regulatory essential documents, including 1572s, delegation logs, training logs, CVs, medical licenses, and financial disclosures.
- Tracking and Monitoring: Track IRB approvals, renewals, and expiration dates across 15+ active clinical studies, ensuring timely follow-up and compliance.
- Collaboration and Communication: Coordinate submissions and maintain effective communication with sponsors, CROs, and site teams to ensure seamless regulatory operations.
- Regulatory Binder Maintenance: Maintain organized and audit-ready regulatory binders (both paper and electronic), ensuring compliance with applicable regulations and guidelines.
- Deviation and CAPA Management: Manage protocol deviations, corrective and preventive actions (CAPAs), and sponsor reporting, ensuring timely resolution and documentation.
- Training Compliance: Track study training requirements and maintain accurate GCP-compliance training logs for all study personnel.
- Audit Preparation: Prepare sites for sponsor audits and FDA inspections by ensuring all regulatory documentation is complete, accurate, and readily accessible.
- Site Activation Support: Support new site initiations and regulatory activation, ensuring all necessary documentation is in place before study start-up.
- Regulatory Updates: Communicate regulatory changes and updates to site coordinators and Principal Investigators (PIs), ensuring everyone is informed and compliant.
Required Qualifications:
To be successful in this role, you will possess the following qualifications:
- Experience: Minimum of 2 years of experience in clinical research regulatory operations, preferably within a multi-site environment.
- Regulatory Knowledge: Strong understanding of FDA regulations (21 CFR Parts 50, 56, 312) and ICH-GCP guidelines.
- IRB Experience: Proven experience working with central and local IRBs.
- Time Management: Ability to independently manage multiple studies and deadlines effectively.
- Attention to Detail: Exceptional attention to detail, documentation quality, and audit readiness.
- Communication Skills: Excellent written and verbal communication skills.
Preferred Qualifications (Added Advantage):
The following qualifications are considered a plus:
- Therapeutic Area Experience: Experience in dermatology, rheumatology, or cardiology trials.
- SMO/Site Network Experience: Previous experience working with SMOs or site networks.
- eTMF Familiarity: Familiarity with eTMF platforms such as Veeva, Florence, or Masterfile.
- Certification: CCRP or ACRP certification.
- FDA Inspection Experience: Experience supporting FDA inspections.
Why Join Stryde Research?
- Competitive Compensation: Competitive India-based salary.
- Remote Work: Fully remote role with US-hours alignment, providing flexibility and work-life balance.
- Growth Opportunity: Opportunity to work with a fast-growing SMO and contribute to its success.
- Impactful Work: Exposure to multi-site clinical operations and high-impact regulatory work.
- Career Advancement: Clear career path with opportunities for growth into Senior Regulatory Coordinator or Regulatory Manager roles.