Enroll subjects in clinical trials and follow their progress through the duration of the study. Perform procedures required by the protocols.

Contracted to manage all aspects of monitoring phase I/II studies. Duties included conducting the Initiation visit, observing the first dosing, conducting Interim Monitoring visits as well as the Close-out visit, completing the Clinical Monitoring Plan, corresponding directly with sponsor as needed, as well as working with the Project Manager to insure the timely and efficient completion of protocols.

Contracted to manage all aspects of monitoring phase I/II studies. Duties included conducting the Initiation visit, observing the first dosing, conducting Interim Monitoring visits as well as the Close-out visit, completing the Clinical Monitoring Plan, corresponding directly with sponsor as needed, as well as working with the Project Manager to insure the timely and efficient completion of protocols.

Assist pharmaceutical companies in the management and monitoring of Phase I - IIIb clinical trials; Assure accuracy and completeness of all study documentation according to FDA regulations and sponsor expectations; Assist sponsor with Investigator site initiation process; case report form review; tracking events associated with Investigator enrollment; adverse event reporting; maintenance of Trial Master File; and CRF completion. Served as team leader for 5 CRAs (3 regional, 2 in-house) for the successful completion of a phase IIIb clinical trial. Co-monitored as necessary, conducted weekly team meetings via teleconference, assisted in management of CRA schedules, tracked enrollment and assisted in the resolution of problems at various sites.Served as a team leader for 25 CRAs (mostly regional based) for the successful completion of three phase III clinical trial. Co-monitored as necessary, conducted weekly team meetings via teleconference as well as weekly in-house core team meetings, assisted in management of CRA scheduling and placement of new CRA's, review and approval of CRA trip reports, tracked enrollment as well as delivered weekly updates to the sponsor, assisted in the resolution of problems at sites and in-house. Also, assisted in the planning and implementation of the pre-study training meeting for all Principal Investigators and Study Coordinators. Coordinated teaching and certification of sites on equipment from outside vendors. Assisted in writing protocols for all three programs and development of Case Report Forms. Wrote CRA guidelines and assisted in the development of CRA tools.

Assist pharmaceutical companies in the management and monitoring of Phase I - IIIb clinical trials; Assure accuracy and completeness of all study documentation according to FDA regulations and sponsor expectations; Assist sponsor with Investigator site initiation process; case report form review; tracking events associated with Investigator enrollment; adverse event reporting; maintenance of Trial Master File; and CRF completion. Served as team leader for 5 CRAs (3 regional, 2 in-house) for the successful completion of a phase IIIb clinical trial. Co-monitored as necessary, conducted weekly team meetings via teleconference, assisted in management of CRA schedules, tracked enrollment and assisted in the resolution of problems at various sites.Served as a team leader for 25 CRAs (mostly regional based) for the successful completion of three phase III clinical trial. Co-monitored as necessary, conducted weekly team meetings via teleconference as well as weekly in-house core team meetings, assisted in management of CRA scheduling and placement of new CRA's, review and approval of CRA trip reports, tracked enrollment as well as delivered weekly updates to the sponsor, assisted in the resolution of problems at sites and in-house. Also, assisted in the planning and implementation of the pre-study training meeting for all Principal Investigators and Study Coordinators. Coordinated teaching and certification of sites on equipment from outside vendors. Assisted in writing protocols for all three programs and development of Case Report Forms. Wrote CRA guidelines and assisted in the development of CRA tools.

Coordinated submission of serious adverse events and follow-up reports from 85 sites to Global Drug Safety and Pharmacoeconomics division of HMR; inspected each SAE and supporting documentation for accuracy and completeness prior to releasing the report to GDSP; assisted team with other duties as necessary, such as: distribution of Study Drug Notebooks, completion of Study File Notebooks, inspection of database for accuracy of regulatory documents, listings, database clean-up. Assisted the medical writing department by serving as a resource for the completion of SAE narratives and by reviewing SAE narratives prior to submission to the Sponsor.

Coordinated submission of serious adverse events and follow-up reports from 85 sites to Global Drug Safety and Pharmacoeconomics division of HMR; inspected each SAE and supporting documentation for accuracy and completeness prior to releasing the report to GDSP; assisted team with other duties as necessary, such as: distribution of Study Drug Notebooks, completion of Study File Notebooks, inspection of database for accuracy of regulatory documents, listings, database clean-up. Assisted the medical writing department by serving as a resource for the completion of SAE narratives and by reviewing SAE narratives prior to submission to the Sponsor.

Coordinated all aspects of large cardiovascular phase III drug trial. Submitted IRB documents for approval; maintained Study File Notebook; screened/enrolled hospitalized patients in trial, coordinated randomization, lab draws, study drug administration, and ECGs, with necessary departments; processed and packaged lab specimens; maintained communication with patients for 36 day and six month follow-ups; monitored patients for non-serious and serious adverse events; coordinated the billing of procedures with all departments; completed case report forms per sponsor specifications and answered database queries until database closure. Maintained open line of communication with Investigators from three cardiology groups conducting the study at this facility.

Coordinated all aspects of large cardiovascular phase III drug trial. Submitted IRB documents for approval; maintained Study File Notebook; screened/enrolled hospitalized patients in trial, coordinated randomization, lab draws, study drug administration, and ECGs, with necessary departments; processed and packaged lab specimens; maintained communication with patients for 36 day and six month follow-ups; monitored patients for non-serious and serious adverse events; coordinated the billing of procedures with all departments; completed case report forms per sponsor specifications and answered database queries until database closure. Maintained open line of communication with Investigators from three cardiology groups conducting the study at this facility.

Assisted in CAT scan and sonogram directed biopsies, drainages, aspirations; assisted Radiologist in sterile procedures during angiography cases; complete responsibility for monitoring patients during procedures and maintaining adequate conscious sedation.

Assisted in CAT scan and sonogram directed biopsies, drainages, aspirations; assisted Radiologist in sterile procedures during angiography cases; complete responsibility for monitoring patients during procedures and maintaining adequate conscious sedation.

Intensive Care Unit and Critical Care Float PoolHad responsibility for total care for patients in surgical and medical intensive care units. Floated through cardiac and pulmonary step-down units as well as the ICU. Monitored telemetry and respiratory equipment, coordinated care of patients with ancillary departments, assisted physicians in discharge planning.

Intensive Care Unit and Critical Care Float PoolHad responsibility for total care for patients in surgical and medical intensive care units. Floated through cardiac and pulmonary step-down units as well as the ICU. Monitored telemetry and respiratory equipment, coordinated care of patients with ancillary departments, assisted physicians in discharge planning.

Screened/enrolled patients in phase III-IV HIV and antibiotic clinical drug trials; coordinated all aspects associated with successful initiation, conduct, and completion of protocols, including IRB approvals, implementing protocol-required procedures, following patients through clinic visits and phone contacts, and completing case report forms according to sponsor specifications.

Screened/enrolled patients in phase III-IV HIV and antibiotic clinical drug trials; coordinated all aspects associated with successful initiation, conduct, and completion of protocols, including IRB approvals, implementing protocol-required procedures, following patients through clinic visits and phone contacts, and completing case report forms according to sponsor specifications.

Assisted pharmaceutical companies in the management and monitoring of Phase III clinical trials; assured accuracy and completeness of all study documentation according to FDA regulations and sponsor expectations; assisted sponsor with Investigator site initiation process, review of Investigator budgets and case report forms; tracked events associated with Investigator enrollment, adverse event reporting and CRF completion.

Assisted pharmaceutical companies in the management and monitoring of Phase III clinical trials; assured accuracy and completeness of all study documentation according to FDA regulations and sponsor expectations; assisted sponsor with Investigator site initiation process, review of Investigator budgets and case report forms; tracked events associated with Investigator enrollment, adverse event reporting and CRF completion.