Ade Otegs
Houston,USA
Summary
A clinical research associate and registered pharmacist with experience in documenting pre-study site evaluations, regulatory document collection. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Associate
Infinite Clinical Trials
02.2020 - 08.2023
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
- Gathered, evaluated, organized, managed and collated information in varying formats.
- Maintained and archived regulatory paperwork.
- Prepared and submitted regulatory file applications and supporting documentation.
Pharmacist Manager
HML Pharmacy
06.2016 - 12.2020
- Kept prescription drugs and controlled substances safe and secure in pharmacy.
- Promoted pharmacy services to patients and medical providers.
- Developed policies and procedures for automatic dispensing devices using EMR systems such as EPIC and Pioneer plus.
- Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
Pharmacist Manager
CVS Pharmacy
06.2014 - 04.2016
- Promoted pharmacy services to patients and medical providers.
Education
Bachelor of Science - Pharmacy
Northeastern University
Boston, MA06.1994
Skills
- Protocol adherence
- Trial methodologies
- Employee training
- Material Review
- Technical Guidance
- Corporate Policies
- Coordinating site operations
- Patient recruitment
- Project Management
Affiliations
Association of Clinical Research Professionals (ACRP)
Certification
- PMP Certified
Timeline
Regulatory Affairs Associate
Infinite Clinical Trials
02.2020 - 08.2023
Pharmacist Manager
HML Pharmacy
06.2016 - 12.2020
Pharmacist Manager
CVS Pharmacy
06.2014 - 04.2016
Bachelor of Science - Pharmacy
Northeastern University