Celline Mitchell

Skills

Research Skills: Clinical Trial Operations, Documentation Management, Good Documentation Practice (GDP), International Council of Harmonisation, (ICH)-Good Clinical Practice (GDP), Good Laboratory Practice(GLP), FDA Guidelines, IRB Submission, Medical Terminology, Protocol Validation, Regulatory Affairs

Technical Skills: Clinical Data Management Systems (CDMS), Clinical Trial Management Systems (CTMS), Data Entry, Document Management, Electronic Data Capture (EDC), Electronic Trial Master File(eTMF), Microsoft Office Suite ( Excel, PowerPoint, Word, etc.), Sharepoint, Spreadsheets

Soft Skills: Adaptability, Attention to Detail, Communication Skills (verbal and written ), Conflict Management, Critical Thinking, Interpersonal Skills, Leadership, Organizational Skills, Problem-Solving, Teamwork, Time Management

About

I am a clinical research professional with 4+ years navigating the clinical setting to include managing clinical trials, patient interaction, and data management. I am interested in bringing my expertise to specifically Rheumatology because of personal experience with this disease and as a clinical research volunteer. In my experience as a Clinical Research Assistant, I created, managed, audited, and tracked source, study and regulatory documents in addition to managing multiple Clinical Data Management Systems across 5 therapeutic areas in addition to managing day-to-day trial activities.
Additionally, I am ICH- GCP certified, with experience in Regulatory compliance and patient safety and rights.