About Hope & Healing Clinical Research

Hope & Healing Clinical Research (HHCR) is a rapidly growing multi-specialty clinical research organization dedicated to advancing medicine through high-quality clinical trials. Our research spans Oncology, Hematology, Endocrinology, Cardiology, Internal Medicine, Primary Care, and other therapeutic areas.
We are seeking a highly organized, detail-oriented Data Entry & Regulatory Specialist to support our Clinical Operations and Regulatory Affairs team. This is an excellent opportunity for someone looking to build a long-term career in clinical research.

Position Summary

The Data Entry & Regulatory Specialist plays a vital role in ensuring the accuracy, organization, and regulatory compliance of clinical research documentation. This position supports study start-up, ongoing regulatory maintenance, data management, and quality assurance across multiple clinical trials.
If you enjoy working with documentation, have exceptional attention to detail, and are passionate about healthcare and research, we'd love to hear from you.

Key Responsibilities

• Enter clinical research data accurately and efficiently into study databases and internal systems.
• Prepare, organize, and maintain electronic and paper regulatory binders.
• Maintain Investigator Site Files (ISFs) and essential study documents.
• Assist with IRB submissions, approvals, amendments, and continuing reviews.
• Track regulatory deadlines and maintain compliance documentation.
• Review documents for completeness, consistency, and accuracy.
• Organize training records, certifications, licenses, and study-related documentation.
• Support study start-up, maintenance, monitoring visits, audits, and close-out activities.
• Coordinate document collection with Clinical Research Coordinators, Investigators, Sponsors, and CROs.
• Scan, upload, file, and archive study documentation.
• Assist with quality assurance and regulatory compliance initiatives.
• Perform other administrative and regulatory duties as assigned.

Qualifications
Required

• Associate's or Bachelor's degree (preferred in Life Sciences, Biology, Healthcare Administration, Public Health, or a related field)
• Excellent organizational and time management skills
• Strong attention to detail and accuracy
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office (Excel, Word, Outlook)
• Ability to manage multiple projects and meet deadlines
• Professional attitude and willingness to learn

Preferred

• Experience in a healthcare or medical office setting
• Clinical research experience (not required)
• Familiarity with Good Clinical Practice (GCP), FDA regulations, or clinical research documentation
• Experience with electronic document management systems

What We Offer

• Comprehensive training and mentorship
• Career growth opportunities within Clinical Research
• Exposure to cutting-edge clinical trials
• Collaborative, supportive team environment
• Competitive salary
• Paid Time Off
• Health, Dental & Vision Insurance
• 401(k)
• Professional development opportunities