Ramona L. Mccaffrey Email & Phone Number

Biopharma, Clinical Trials Management

San Diego, California, Us

San Diego, California, Us

East Hanover, Nj, Us

As Clinical Project Manager, managed multiple trials simultaneously (Phases I, III, IV) in various stages (start-up, maintenance, closeout); assisted with 3 Phase I safety/pharmacokinetic studies (SAD/MAD, renal, and ELF)–document preparation/QC; assisted with 3 Phase III active comparator studies (cUTI, CRE, and HABP/VABP)–document/data QC and insurance procurement; worked closely with U.S. and ex-U.S. (government and industry) partners to progress studies in a timely manner according to FDA and EMA regulations; oversaw study conduct and ensured implementation according to protocol and in compliance with local, ICH-GCP, and company policies/procedures; pro-actively managed study timelines, budgets, and risks; collaborated with legal and finance to manage study-specific agreements (non-disclosure agreements, consulting agreements, clinical trial agreements, budget and payment terms, CRO/vendor agreements, change orders, etc.); assisted with vendor and site selection processes; assisted with vendor budget/timeline negotiations and management; performed in-person and remote pre-study site visits, site initiation visits, monitoring visits, and site close-out visits; developed, tracked, collected, and QC'd essential study documents (protocol, IB, ICF, CRF, study manuals, trainings, etc.) or ensured completion by CRO or internal staff; contributed to data table design and data review/QC with manuscript structure in mind; assisted with monthly/quarterly study reports for internal team and external partners; performed in-depth literature reviews and compiled summaries to provide supporting data for study-related topics; assisted with maintaining Trial Master File; assisted with site preparation for FDA and other international regulatory agency inspections; assisted with successful NDA and MAA submission by performing document/data QC and writing subject narratives for SAE reporting

o Program Manager: Actively assisted team in planning first-in-class Phase IIb norovirus vaccine clinical trial; coordinated U.S. Navy and pharmaceutical industry sponsor in contract and protocol development and creation of source documents (ICF, CRF, diary cards, etc.); developed/managed study timelines/budgets; coordinated study logistics across multiple trial sites; organized/participated in site selection visits and mock trials; participated in vetting/hiring of contract staff; ensured trial compliance with FDA, ICH-GCP, IRB; ensured trial-supporting clinical laboratory compliance with GLP, CAP; managed trial-supporting clinical assay development, validation, and data acquisition/analysis; prepared reports for internal leadership and sponsoro Principal Investigator: created/implemented protocols for 7 large-scale, local and international studies characterizing epidemiology/etiology of gastrointestinal disease affecting international military, support, and traveler populations; ensured regulatory compliance with GLP, CAP, IRB guidelines; developed/managed contracts, protocols, and source documents; managed study timelines/budgets; wrote quarterly/annual reports for sponsors and stakeholders; achieved > $2.25M in funding for organization via attainment of multiple competitive grants o Lab Supervisor: helped build state-of-the art infectious disease surveillance program from the ground up; developed/managed study timelines/budgets; ensured full laboratory compliance with GLP, CAP regulations and successfully prepared lab for inspections; designed, improved, and implemented study SOPs; developed study protocols and source documents and managed continuing reviews in compliance with local IRB; utilized local electronic medical database to identify potential study subjects at field site; consented, interviewed, and enrolled study subjects and collected clinical specimens for trial-supporting lab research; hired, trained, and managed up to 8 Research Assistants

Characterized novel mechanism by which the Gram-negative intracellular bacterial pathogen and Category A Select agent, Francisella tularensis, inhibits primary human innate immune cell activation

Iowa City, Iowa, Us

Identified novel mechanism by which the Category A Select agent, Francisella tularensis, inhibits activation of primary human neutrophils and macrophages

Ph.D., Molecular And Cell Biology

Bachelor Of Science (B.S.), Molecular, Cell, And Developmental Biology