As a foreign-trained clinical physician with extensive experience as a Clinical Research Associate (CRA) in Cameroon and Europe, I bring over several years of expertise in site start-up, project oversight, and monitoring within clinical research settings.
My background spans therapeutic areas encompassing Phase I to IV trials in Oncology, Hematology, Allergy, and Medical Device studies. Moreover, I possess a solid foundation in biomedical laboratory research, and I have honed my skills and career in navigating the complexities of clinical environments in Africa and Europe, which has provided me with a comprehensive understanding of the unique challenges and dynamics within these regions.
My focus remains on delivering results, and I am equipped with strong oral and written communication abilities, exceptional organizational skills, and a knack for problem-solving. I am eager to contribute my expertise to any remote job opportunity in a Clinical Research Associate position, leveraging my extensive clinical background and diverse experiences to drive impactful research outcomes
During my tenure as a Project Research Assistant at the Oncology Unit of Johns Hopkins Hospital in Baltimore, MD, I managed the collection, review, and maintenance of crucial regulatory documentation while overseeing the preparation and distribution of study materials and reference tools for sites. Additionally, I coordinated the logistics of study supplies, tracked regulatory documents and enrollment, and contributed actively to project meetings, ensuring accurate minutes and facilitating investigator debarment checks during site initiation.
As the COVID-19 Coordinator and Head of Covid Vaccine Monitoring at Company Tunn3l JV in Copenhagen, I served as the main liaison for Principal Investigators and clinical site staff, facilitating on-site visit readiness and conducting regular contacts focusing on recruitment, data entry, and patient safety. I ensured compliance by reviewing clinical system data, managed site issues by recommending solutions, and oversaw their resolution while also conducting remote re-training for site staff. Additionally, I collaborated with the Danish Ministry of Health, led negotiations, prepared regulatory documents, and mentored team members to establish effective site management tools during the COVID-19 pandemic.
As a Clinical Research Associate, my responsibilities included conducting initiation visits, actively participating in various meetings, and collaborating with Clinical Monitoring Associates to resolve site issues prior to scheduled visits. I oversaw site-specific training, collected regulatory documents, and conducted facility inspections, ensuring compliance with ICH-GCP standards and prioritizing patient safety. Additionally, I successfully identified and resolved regulatory concerns at sites, prepared detailed monitoring visit reports, and collaborated with site staff to establish efficient recruitment plans during initiation visits. An integral part of my role involved reviewing clinical system data, rectifying data quality issues, and managing Trial Master File documentation by shipping original documents to the paper TMF while archiving copies in the electronic TMF. Moreover, I contributed to Human Papillomavirus (HPV) vaccine research and its integration into the National Immunization Program in Cameroon
Working towards Clinical Research Professional Certifications
Proficiency in Microsoft Office, Adobe Acrobat, Adobe Photoshop, safety reporting, medical terminology, IMPACT, IWRS, Medidata RAVE, adherence to Good Documentation Practice, ICH-GCP standards, and utilization of WebEx for remote communication and collaboration.