Clinical Development Sciences, Hematology & Nephrology

Medical expert and primary contact for investigators, clinical site staff, and project team for protocol compliance, medical and safety-related issues for all assigned clinical trials.Medical safety oversight including safety data analysis to identify and manage emerging safety signals, supports pharmacovigilance in triage of AEs/SAEs/SUSARS and reporting to regulatory authorities. Medical review and evaluation of clinical trial data, medical coding (MedDRA and WHO DD).Contributes to the development of Medical Monitoring plans, Safety Management plans, CRFs, Risk management, protocols, informed consent, lab manuals, and other study documentation.Knowledge of GCPs, GVPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines to ensure compliance with regulatory and legal standards. Develops and maintains relationships with key opinion leaders, principal investigators, and within all functional areas of internal and external partners.Provides training and support in assisgned therapeutic areas to investigators, site, and Premier’s personnel. Presents at KOM’s and Investigator meetings.

Performed all aspects of in-house site management and monitoring for 27 investigator sites for two concurrent phase III Chronic Lymphocytic Leukemia drug trials.Developed collaborative working relationships with investigators and clinical site staff to guide and support sites’ execution of their study responsibilities and meet all study benchmarks and timelines. Successfully decrease findings, resolve queries, reduce protocol deviations. Primary contact for ad hoc requests, site training, and resolution of internal or vendor systems. The primary regulatory reviewer for the studies’ protocol and informed consent forms (ICF) amendments. Successfully anticipated IRB specific requirements for decrease turnaround time and resource allotment.

Key Research Assistant conducting innovative research to unravel receptor mechanisms in potential and current psychopharmacological agents in the treatment of mental disorders including schizophrenia, bipolar disorder, and depression. Simultaneously managed several complex behavioral analyses and behavioral trials for investigation of cognition in schizophrenia—conducted analysis of research publications and study data to support study design. Consistently produced and delivered high-quality data for manuscript publication, presentations at symposiums, and pilot studies that led to grant funding from NIH and private sectors.Trained all new staff, graduate students, interns, and medical students on study designs and protocols.

Lead clinician in an experimental multi-disciplinary, single point of responsibility community mental health clinic focusing on African Americans suffering from severe mental disorders, substance abuse, and socioeconomic issues.Forged vital strategic relationships with government and private agencies to help share the cost of providing care and advocating health, legal, housing, and economic services. Played a leading role in the development and implementation of an overhaul of the direct observational therapy program that produced a 75% reduction in high-cost services, including hospitalizations and emergency department visits.