Hard Money Lender and Real Estate Investor

Management of site monitoring, including involvement in many steps of the Phase 1 clinical trials process. Monitoring and coordinating the clinical trial conduction while ensuring compliance with GCP and applicable SOPs. Tracking progress, status, and site performance. Identified and resolved site and study problems/issues and created appropriate action plans when necessary. Coordinating and providing input to various clinical trials activities including protocol presentations, query resolution, site qualifications, initiations, & closures, collection of regulatory submissions, creating trip reports. Ensured that all clinical systems were updated and current, including but not limited to, IMPACT, Quantum, and EDC systems. Ensuring that all SAEs and adverse drug reactions are reported and followed up in a timely manner. • Assigned to 6 different protocols across various sites within an extremely short amount of time of joining the team; completed 2 site qualification visits, 2 site initiation visits, and 13 interim monitoring visits within the first month of being hired to the Phase 1 team. • Submitted all monitoring visit reports within about 3 days of the completion of each visit in 2011-2013. 99% compliance with all training and the submission/completion of metrics and expense reports from 2011-2013. • Created unique and effective monitoring tools to help ensure that I efficiently and effectively transitioned into the new role as a Phase 1 monitor.

Supported all world-wide clinical personnel with all enterprise systems questions and user needs. The role required an in-depth knowledge of both pharmaceutical clinical research operations and in depth knowledge of all CSMS related business systems, including working with the individual study teams to set-up the subject visit designs within IMPACT and ensuring that accurate data-loading was occurring between various vendor EDC and IVR systems and the Abbott IMPACT (and other) systems. Supported senior personnel in their use of reporting tools such as Cognos and interpreting of summarized data.

Responsible for the oversight of monitoring activities and site issues for clinical trials. Ensure site compliance with FDA regulations, ICH/GCP guidelines and s-a/Contract Research Organization (CRO) SOPs, in support of US and Global Medical Affairs trials. Supervising and training responsibilities for Contract CRAs. Support the development of the Regional Clinical Operations (RCO) Group and Medical Operations through participation in special projects and assignments. Responsible for high quality completion of audit report responses for assigned trials.

Followed study monitoring plans; conducted study site visits; extensively communicated with investigative sites; reviewed and verified source documentation; directed data query resolution by the sites; reviewed and ensured appropriate reporting of adverse events; verified appropriate receipt, handling, storage, dispensing and return of clinical trial material; ensured that adequate supplies were maintained at the site; training of site personnel; assured that all Investigator obligations were fulfilled, assured an ongoing compliance with study protocols and that all facilities remained acceptable for study purposes; assessed accuracy, completion and currency of study records; verified that appropriate informed consent processes were followed for all trial subjects; conducted study site closure activities; completed monitoring visit reports, etc.

see description for P&G above

Responsible for conducting studies according to Winston SOPS, GCPs, ICH guidelines and other federal regulations. This included writing study protocols, designing case report forms, and writing Informed Consent Forms and other study documents. I oversaw and trained study staff including supervision of contract work. Participated in selection of CROs and contract CRAs. Supervised CROs and contract CRAs conducting clinical studies; including budget and contract negotiations, training and communicating Winston SOPs and expectations, planning content for study meetings, selection of study investigators, and reviewing trip reports. I oversaw serious adverse events (SAE) reporting, including assessing adverse events and communicating safety concerns to relevant parties and the medical director. Collaborated with other project team members, as appropriate, to: develop study timelines, classifying subjects for inclusion in specific analyses, writing clinical sections of summaries, reports, select NDA documents and FDA reports. I was responsible for calculating, tracking, and managing the study budget and financial information. Responsible for occasional co-monitoring of sites.

Responsible for ensuring adequate complement of Clinical Research Associates within Clinical Operations. Guided ongoing training, career development, and CRA processes within Clinical Operations. Assigned adequate resourcing to projects. Directly supervised: Clinical Research Associates, Site Selection Specialists, Clinical Research Assistants, Administrative Assistants, and Records Coordinators. Worked closely with: Regional Directors, Other Line Managers, Project Managers, Client Relations Group/Proposal Dev. Group, Training Department, Quality Control Managers, Human Resources, Information Systems, and Finance. Responsibilities included: recruiting, terminating, overseeing orientation, position-specific training, performance evaluations, compensation recommendations, promotions, career development, and the resolving of employee issues potentially impacting work assignments. Also responsible for calculating resource needs, ongoing assessment of staffing needs for current and potential projects, performed co-visits and Central File review. Identified individual and department training needs, technical support to primary CRAs and project team members as needed, monitor departmental compliance to SOPs, and drove process improvement initiatives.

This family business was a popular Chicago restaurant/nightclub. I was jointly responsible for all business activities during this tenure.

Oversaw the conduct of clinical trials and ensured the quality and integrity of the data and safety and efficacy of the drug. Conducted monitoring of clinical trials, report writing, and report review. Interfaced with clinical investigators and other site personnel in order to carry out this and other responsibilities. Analyzed and evaluated clinical data. Ensured compliance with protocol(s) and overall clinical objectives. Ensured site compliance with FDA regulatory requirements and ICH Guidelines and Standard Operating Procedures. A large amount of creativity and latitude was required.

Responsibilities included lectures, teaching discussion groups, evaluating projects/papers. Instructor of class ‘Development of Human Communication’. Responsibilities included creating syllabi, lecturing, creating exams and evaluating projects/papers, and delivering final grades.

Managed staff in direct care of developmentally and physically challenged children and adults. Distributed and tracked medication routines, scheduled psychiatric and general health appointments, coordinated family involvement, assisted in the hiring and evaluating of employees