Job Summary |
Under the supervision of the Clinical Research Operations Manager, the Clinical Research Regulatory Analyst completes and maintains regulatory documents for clinical research projects to ensure compliance with the study protocol, established institutional policies and procedures, applicable regulations and Good Clinical Practice (GCP) Guidelines. He/She will also manage all aspects of day-to-day regulatory operations and supporting clinical research regulatory matters as follows: study intake and feasibility assessment facilitation, start-up, Institutional Review Board (IRB) / Sponsor submissions, modification submissions, continuous reporting, and study close-out; financial support; communicate with internal and external stakeholders; and any relevant regulatory agencies. This position will be responsible for managing all central documents, e.g., credentials & training files for all study staff; lab documents; IRB manual, forms and documents.
Education |
Education Type |
Program of Study |
Required/Preferred |
High School Diploma |
N/A |
Required |
Associate’s Degree |
Business, Science, or Health related field |
Preferred* |
Bachelor’s Degree |
Business, Science, or Health related field |
Preferred* |
Master’s Degree |
Nursing, Science, or Health related field |
Preferred* |
*Will consider experience in lieu of education
Experience |
Number of Years |
Type of Experience |
Required/Preferred |
1-2 years |
Clinical Research regulatory, professional or related experience |
Required * |
*One (1) year if bachelor’s degree
Certification & Licensures |
Certification/Licensure Type |
Required/Preferred |
Certified Clinical Research Professional (CCRP) or related certification |
Preferred |
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