Employer Industry: Healthcare and Clinical Research

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work remotely with a flexible schedule
- Engaging in a complex portfolio of investigator-initiated trials
- Collaborate with a dedicated team in a nationally ranked healthcare system
- Chance to make a positive impact on clinical research and patient care

What to Expect (Job Responsibilities):
- Serve as the primary regulatory contact for assigned protocols
- Maintain electronic regulatory binders/files and ensure appropriate version control
- Coordinate submissions to ancillary committees such as Radiation Safety and Institutional Biosafety
- Communicate with the IRB and sponsor on behalf of the study team regarding regulatory management
- Prepare regulatory files for auditing and monitoring visits

What is Required (Qualifications):
- HS diploma with 6 years of clinical research experience or a Bachelor's degree in a scientific or healthcare-related field with at least 2 years of clinical research experience, or a Master's degree in a scientific or healthcare-related field with 1 year of clinical research experience
- SOCRA Certification
- Strong written and oral communication skills
- Experience working with grant-funded and Investigator-Initiated clinical trials
- Knowledge of Good Clinical Practices and FDA Rules and Regulations related to clinical trials

How to Stand Out (Preferred Qualifications):
- Familiarity with clinical trial management systems, such as OnCore and ClinicalTrials.gov
- Demonstrated ability to work independently and with a team
- Proficiency with Microsoft Office, including Outlook, Teams, OneNote, Word, and Excel

#ClinicalResearch #HealthcareCareers #RemoteWork #RegulatoryCompliance #CareerOpportunity

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