Lanre Dosunmu
Clinical Research Associate at Ora
- Role
- Senior Clinical Research Associate at Ora
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Lanre Dosunmu
Senior Clinical Research Associate with years of clinical research experience…
Experience
Senior Clinical Research Associate
Jan 2017 — Present · US
Clinical Research AssociateMaintain timely and effective communication among team members and site staff. Identify potential issues and implement corrective actions independently. Assure compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference on Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintain current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Responsible for site management and site staff performance including: monitor all types of clinical trials; participate in all types of site visits; assure compliance with all protocol requirements; assure effective patient identification and recruitment plan is in place; assure timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensure proper storage, dispensation, and accountability of all Investigational Product(s) and trial related materials; regularly review the status of the contents of the site regulatory binder; exhibit superior time management skills. Perform source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Perform clinical data listings reviews as needed.Complete and submit reports according to SOP/Work Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintain awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit
Education
University of Lagos
Bachelor of science
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