Clinical Operation/ CRA

Objective:

To contribute my extensive Clinical Trial, Monitoring and CRO experience to the success of a prospective employer

Highlights of Qualification:

• Over nine years experience in Pharmaceutical research. Excellent verbal/ written communication skills

• Good organizational and time management skills. Advanced knowledge of CESR (subject data base), CTA process, ERB/IRB application, protocol writing and company SOP writing, study monitoring and site monitoring

• Experience in company budgeting (employee salary, supplies purchasing, external service budget tracking)

• Managed employees (technicians, nurse, MA, CRC/SC, Data reviewer, QC, CRT supervisor).

Professional Accomplishment:

• Established 3 start up CROs BA/BE/First-In-Man clinics.

• Built and established Telephone Recruiting and Medical Screening Department that lead to generating thousands of subjects registered in Database in less than 3 months.

• Developed clinical training programs, procedures and hiring technique that create consistency in procedure, clinical data collection and expedite reports.

• Developed clinical data management and training program that create clinic report process by at least 1 week earlier than usual time.

• Promoted five times in different senior positions with in few years

Clinical Research Experience:

March 2008- Present Acclaim Pharma Research Inc. (Phase I BA/BE First-in-man studies) Director, Clinical Development & Operation

Manager CRA (Phase II-IV Dermatology studies) London, Ontario,

• Ensure timely and quality clinical trial activities at each assigned investigative site, according to pre-set Key Performance Indicators (KPI)

• Represents the sector, both internally and externally, as a source for consultation and/or information and/or reference

• Set-up and management of Phase I/BE unit including design, equipment purchase, SOP development and job descriptions.

• Develop study designs and proposals for contracts for Phase 1/ BE studies. Contributes to the development of their sector’s budget, ensures that it is being adhered to, performs budget follow-up for pertinent stakeholders and recommends actions in an effort to achieve the expected results.

• Visit Assign sites to ensure that staffs are trained in the protocol.

• Monitor and report the progress of the trial at assigned site.

• Ensure appropriate site selection, timely start of patient recruitment.

• Appropriate clinical trial recruitment according to set timelines and quality standards, as defined by the clinical study protocol and clinical study team. Distribution and accounting for trial materials furnished to sites.

• Ensuring of appropriate site, data and patient monitoring

• Ensuring investigative site adherence to quality and Good Clinical Practice standards.

• Train site investigative personnel on trial study conduct, use of trial related tools, and general adherence to Good Clinical Practice, to ensure quality of data and site competence in both quality assurance and control.

Collection of accurate, quality and timely dataPlans, organizes, manages and monitors their sector’s activities/operations according to their field of expertise, strategic and tactical alignments, and the needs of the organization in order to achieve the expected results.

• Responsible for the overall strategic development and operations management for the planning and execution of Phase 1/Bioequivalence trials

• Monitor staff workloads and productivity; meet with staff on a regular basis to review professional development which includes the preparation and conducting of performance appraisals for direct reports

• Recruitment and training of new staff, performance management and daily monitoring of productivity; facilitates knowledge development and transfer; and ensures the efficiency and mobilization of the team in order to achieve the expected results.

• Source, evaluate, and select 3rd party vendors to ensure project objectives are met

• Prepare and manage budgets as needed for outsourced/in-sourced resources

• Ensure compliance with appropriate Acclaim Pharma Services SOP’s GCP and ICH guidelines.

Sept. 2006- Dec. 2007 BioPharma Services Inc. Toronto, Canada

Manager, Clinical Research

• Assist the COO, VP Business Development in developing strategies, forecasts and tracking of study procedures. Assist the COO, VP Business Development in closing new study contract deals by coordinating study requirements; developing strategies; integrating study requirements with business operation.

• Overseeing/monitoring the day-to-day operation of the recruiting, medical screening and Clinical on-study procedures.

• Work with COO and VP Business Development to ensure that the study requirement and study project proceed effectively and efficiently.

• Ensure study requirements are fulfilled and maintain excellent business relationships with multiple pharmaceutical companies (sponsor/client)

• Develop advertising strategies according to the ERB requirements in collaboration with the Clinical Operations Platforms, including forecasting, preparation and updating of clinical project and trial budgets, negotiate subjects’ fees, etc.

• Prepare Clinical Operations to ensure appropriate study dates to the clinical project.

2003-2006 Pharma Medica Research Inc. Toronto, Canada

Clinical Training Manager

2002-2003 Pharma Medica Research Inc. Toronto, Canada

Study Coordinator/Clinical Training Coordinator

• Generate study summary based on study protocol

• Generate CRF (case report forms) based on protocol requirements

• Set up and conduct pre-study protocol review meeting of study activities for technical team

• Supervise the timely planning and execution of studies

• Assist Principal Investigator in signing reports required for study. Ensure the physician is informed and available for each pre-study medical and study period

• Ensure subject safety by monitoring and documenting adverse event

• Ensure Eligibility of the qualifying panels of volunteer subjects

• Ensure all study documentation is current according to SOP and GCP

2000-2002 Pharma Medica Research Inc. Toronto, Canada

Bundling and Shipping Supervisor/Assistant Coordinator

• Supervise and/or perform Recruiting of Subjects (volunteers)

• Ensure procurement and/or processing of biological samples as required to conduct a clinic study

1999-2000 Pharma Medica Research Inc. Toronto, Canada

Medical Research Assistant/Screening Technician

• Obtain Blood Specimen. Perform Vital signs

• Perform ECG, glucose monitoring and oxygen level

EDUCATION

2009 Clinical Research Associates Program (CRA) + GCP Certificate , Kriger International Ontario Canada

2003 Training Manager Certificate, Langevin Learning Institute, Toronto, Canada

1998 Phlebotomy Certificate, Laboratory Arts Institute, Toronto, Canada

1993 Bachelor Science Medical Radiologic Technology, University of Batangas, Philippines (Diploma, Registered)

1992 Associate Medical Radiologic Technology, University of Batangas, Philippines (Diploma, Registered)

SEMINAR AND PROFESSIONAL MEMBERSHIP

• Philippines Association of Radiologic Technology Member 1992-present

• Society of Clinical Research Associates (SoCRA), Member, 2004-Present

• Association of Medical Radiologic Technologist 1993-Present

• Rescuer Cardio-Pulmonary Resuscitation (C.P.R.). Canadian Red Cross, 2008

• The CRC’s Guide to Coordinating Clinical Research, American Health Consultants, 2006

• Introduction to Clinical Research, Clinfosource, 2006

• Investigator Responsibilities, Clinfosource, 2006

• Vasofix Intravenous Catheter Placement and Insertion by B.Braun Company 2002- 2008

• Informed Consent: Elements and documentation, Clinfosource, 2006

• Dealing with Difficult Employees Effectively by Skillpath (Toronto, Canada), 2005

• Science Courses by Society of Clinic Research Association (SoCra) (Colorado, USA) 2004

• Association of Clinical Research Professionals, Member, 2006

• PHIPA Privacy Training, CliniCoach, 2005

• GCP, Quality systems training, 2003-2008

• WHMIS & Supervisor safety training, 2004-2008

• Investigator Training Program 19 June 2009 London Ontario (sponsored by Pfizer Canada with Lawson Health Research Institute)

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