ANDREW OGUNYE

Dedicated Senior Clinical Research Associate with experience overseeing clinical trials across multiple phases within the pharmaceutical and biotechnology industries. Proficient in ensuring adherence to protocols, regulatory requirements, and quality standards while fostering collaborative relationships with cross-functional teams, CROs, and investigational sites to facilitate seamless trial execution. Skilled in conducting pre-study, site initiation, routine monitoring, and close-out visits, consistently driving successful trial outcomes. Proven ability to streamline processes, mitigate risks, and deliver high-quality results within strict timelines. Seeking to leverage expertise in clinical trial management to contribute to the advancement of innovative therapies in a dynamic clinical research environment.

Hardworking CRA successfully leads site evaluations, initiations and closeouts. Well-versed in clinical trials by Offering advanced planning, problem-solving and communication skills developed over 6+ years of clinical research success.

Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.

• RN License
• GCP
• BLS
• ACLS

• Deep knowledge of clinical trial processes, GCP guidelines, and regulatory requirements, ensuring a comprehensive grasp of the entire research lifecycle.
• Proficient in conducting site visits, including initiation, interim monitoring, and close-out visits, with a focus on ensuring protocol adherence and resolving site-related issues.
• Adept at reviewing and comprehending study protocols, actively contributing to their development, and assessing their feasibility for successful implementation.
• Committed to ensuring the quality of clinical trial data and processes, with a focus on maintaining high standards of accuracy and compliance.
• Competent in identifying and mitigating risks associated with clinical trials, actively contributing to the development and implementation of comprehensive risk management plans.
• Solid analytical and problem-solving abilities, capable of identifying and promptly addressing issues based on a thorough understanding of the clinical trial process.
• Exceptional interpersonal skills to collaborate with cross-functional teams, project managers, and other stakeholders, while providing leadership and mentorship to junior CRAs.
• Superior organizational and time management skills, adept at prioritizing tasks to meet deadlines, and capable of managing multiple projects concurrently.
• Excellent verbal and written communication skills for effectively liaising with study sites, sponsors, and internal teams while producing comprehensive trial reports and other essential documents.
• Proficient in several software and tools used in clinical research, including IVRS, EDC, CTMS, Epic, Cerner, PCC, ProTouch, and Microsoft Office (Word, Excel, PowerPoint).

• Hematology-Oncology: Solid Tumor Cancer, Lung Cancer, Pancreatic Cancer, Breast Cancer, Melanoma, Colon Cancer, Liver Cancer.
• Gastroenterology: Inflammatory Bowel Disease
• Nephrology: Membranous Nephropathy, Renal Cell Carcinoma
• Medical Device: Pace Marker, AML, Heart Valves.
• Ophthalmology: Macular Degeneration, Diabetic Retinopathy, Retinal Dystrophy.
• Psychiatry: Treatment Resistant Depression, Bipolar Disorder, Tourette Syndrome, Parkinson’s Disease, Essential Tremors Schizophrenia, ADHD
• Central Nervous System: Alzheimer's, Spinocerebellar Ataxia, Epilepsy, Myasthenia Gravis
• Infectious Disease: Hepatitis C, HIV/AIDS