Joel Victor

Experienced professional in pharmaceutical clinical trials, specializing in leading and managing Phases I-IV studies. Focus on aligning with research objectives and protocols for positive study outcomes. Effective supervision and education of site personnel on clinical trial protocols to foster high protocol compliance and reduce deviations. Creation of clinical trial and patient flow manuals of procedures and Standard Operating Procedures to ensure proper training and guidance for maintaining protocol integrity and achieving accurate results. Generates accurate and comprehensive data reports adhering to protocol guidelines, providing valuable insights for decision-making and regulatory submissions. Meticulous attention to detail ensures precise research outcomes and upholds data integrity throughout the study. Upholds protocol compliance, ethical drug development, and contributes to scientific discoveries as core values. Adheres to highest standards of integrity and credibility in the clinical research field, making a significant impact on the reputation and success of managed studies. Successful project management relies on effective collaboration and communication. Collaborates with cross-functional teams including investigators, study coordinators, and sponsors, fostering open lines of communication and ensuring smooth study execution for overall success and timely completion of projects. Experience in project management within pharmaceutical clinical trials includes leading and managing studies, supervising personnel, generating accurate data reports, upholding protocol compliance, and collaborating with cross-functional teams. Commitment to excellence and ethical standards positively impacts the success and credibility of involved studies. Accomplished Clinical Research Associate with 15 years of experience performing pre-study site evaluations, regulatory document collection, interim monitoring, and study close-out visits. Diligently conducting studies aligned with good clinical practices, study-specific requirements, and clinical monitoring plans. Possesses in-depth knowledge of company procedures, regulatory requirements, and quality standards.

• CITI Human Subjects Protection Training (Biomedical Research)
• CITI Good Clinical Practice (GCP)
• CITI IRB Members Responsible Conduct of Research - RCR
• IATA Certified (hazardous and biological material shipment training)

• Oncology, US
• Multiple Myeloma & Plasma Cell Lymphoma
• Hodgkin
• Non-Hodgkin
• Acute Myeloid Leukemia (AML)
• Adult & Pediatric Acute Lymphoblastic Leukemia (ALL) Treatment
• Stem cell transplant
• CAR T-cell therapy
• Adult & Pediatric Myelodysplastic Syndromes (MDS)
• Phases I-IV - Breast Cancer and Renal Cancer
• Phases I-IV Gastrointestinal (GI) Cancer
• Head & Neck Cancer
• Infectious Disease, US and Global
• Phases I-IV Cancer Clinical Trial for Patients with HIV

• Society of Clinical Research Associates - Member
• Black Men in Clinical Research (BMICR)- Member
• Freemason
• Phi Beta Sigma Fraternity, Inc.

• Recruitment Plan Development
• Therapeutic Oncology Expertise: Phase I-IV
• Site Staff Training
• Completion Regulatory Policies
• SOP Development
• SIV, IMV, COV
• Ethics in Clinical Research
• Profound knowledge of ICH-GCP and other relevant regulatory requirements.
• Oncology Clinical Trial
• Microsoft Proficient
• Medicare Coverage Analyst
• IRB Submission
• Proficiency in and ability to learn new clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools.
• Site Visit Report Reporting
• AE/SAE Reporting
• EDC Management (Data labs, RAVE, Inform, Redcap, etc.)
• Case Management
• Research SOPs understanding
• Source Data Verification
• Query Resolution
• Study-Level Tracking
• Heme /Onc. Research Program Development
• High level of organization, multi-tasking, judgment, and keeping to timelines