MARCELA MARTINEZ

*** *. ********

SAN ANTONIO, TEXAS 78212

210-***-****

Email: acsgdt@r.postjobfree.com

CAREER OBJECTIVE

Enthusiastic and self-motivated individual seeking to obtain a challenging position in the research and development industry. Seeking to continue utilization of my analytical and management skills as well as enhancing the health and wellness of our society.

QUALIFICATION HIGHLIGHTS

Quality Maintenance Analytical Planning Project Leadership

Process Improvement Development Training FDA Audit Experience

EDUCATION

Our Lady of the Lake University San Antonio, Texas

Bachelor of Arts, Biology May 1996

PROFESSIONAL EXPERIENCE

Worldwide Clinical Trials (WCT) San Antonio, Texas

Documentation and Compliance Associate II Nov 2011-July 2015

Quality Control associate responsible for the analysis and data management of Phase I-IV clinical trials to ensure protocol adherence

Review of each study protocol to assure quality and completeness of trial documentation.

Serve as an in-house monitor to ensure quality review of source documents, Case Report Forms and corresponding data tables.

Assist with review and maintenance of clinical data, including pharmacy documents from trial implementation through completion.

Provide Quality Control oversight during drug dispensation to ensure adherence of standard operating procedures.

Assist in the training of colleagues regarding pharmacy documentation preparation, completion, analysis and oversight of drug dispensation.

Participate in department trainings and discussions to assist in the promotion of effective teamwork.

Ensure appropriate communication on project related matters with management.

Identify and initiate process improvements to enhance the efficiency and quality of work performed on assigned projects.

Conduct Quality Control audits of data and clinical procedures to ensure quality work is being performed, as well as communicating important findings with the Quality Assurance department.

Assist in meeting WCT timelines to achieve project milestones for sponsor and FDA submission.

Maintain required OSHA and GCP training as well as comply with company policies, procedure and SOPs

Perform other duties as assigned.

City of San Antonio Metropolitan Health District, Immunization Division San Antonio, Texas

Senior Management Analyst/Clinical Trial Coordinator-Manager Feb 2004-Nov 2011

Coordinate, plan, execute and manage numerous Phase II-IV clinical trials and ensure protocol adherence.

Responsible for presenting overall clinical trial objectives of new research projects to research staff.

Responsible for providing thorough training of research procedures and exercised supervision over staff.

Developed timetables for projects from initial development stages thru actual implementation and completion.

Maintained knowledge of Good Clinical Practice (GCP) procedures and trained staff on new information.

Utilized Internet and web-based computer applications for data entry.

Reviewed numerous clinical trial contracts and prepared budgets for city council review.

Analyzed and managed budgets to secure project funds from pharmaceutical agencies in coordination with city departments.

Maintained Institutional Review Board (IRB) requirements and regulatory files, including the preparation and submittal of regulatory documents for trial approval.

Responsible for management of study and IRB submission/approval files for sponsor and Federal Drug Administration audits.

Managed Financial Certification Disclosures for clinical research trials to ensure compliance with ICH guidelines/

Federal Code of Regulations.

Served as a liaison with pharmaceutical agencies, monitoring personnel, collaborating physicians and research staff.

Coordinated delivery of contract services between pharmaceutical agencies, city vendors and departments.

Maintained partnerships with various global pharmaceutical corporations and research organizations to ensure new clinical trial opportunities.

Developed and revised ‘Standard Operating Procedures’ for Clinical Trial Program

Evaluated system policies and procedures and provided recommendations for process improvement.

Conducted and assisted with interviews of new staff for the Immunization division.

City of San Antonio Metropolitan Health District, Immunization Division San Antonio, Texas

Health Program Supervisor/Clinical Trial Coordinator Aug 2003-Feb 2004

Assisted in the coordination, planning, execution and management of numerous Phase II-IV clinical trials to ensure protocol adherence.

Provided thorough training of clinical trial procedures regarding each protocol to clinical trial staff.

Assisted as a liaison with pharmaceutical agencies, monitoring personnel, collaborating physicians and clinical trial staff.

Assisted the clinical trial staff in client recruitment and enrollment in compliance with various protocols.

Assisted the clinical staff with invasive procedures and medical assessments.

Maintained accurate inventory of general supplies, study vaccine and serum samples.

Utilized Internet and web-based computer applications for clinical trial data entry.

Exercised supervision over clinical trial staff.

University of Texas Health Science Center San Antonio/START Center San Antonio, Texas

Social Science Research Associate II/Project Coordinator Mar 2001-Jul 2003

Coordinated with Primary Investigator to implement Phase II-IV research protocols and procedures.

Provided training of clinical trial procedures regarding each protocol to clinical trial staff.

Collected research data through clinical interviews and medical assessments.

Coordinated activities of study participants collaborating with nursing staff and multidisciplinary team.

Utilized Internet and web-based computer applications for clinical trial data entry.

Demonstrated Good Clinical Practice (GCP) per FDA Guidelines for Clinical Trials.

Maintained regulatory files for each study protocol.

Maintained budget for subject compensation.

Exercised supervision over study staff.

Diagnostic Clinic of San Antonio/David M. Crouch, M.D. San Antonio, Texas

Medical Office Assistant Oct 1991-Jan 2000

Coordinated and assisted with patient appointments, including surgical procedures.

Obtained patients’ vital signs and initial medical histories.

Changed postoperative dressings with aseptic technique and assisted with medical procedures.

Maintained patient charts, including transcription.

Maintained medical office supplies inventory.

Conducted sterilization of all medical equipment.

Assisted with insurance billing and accounts receivable.

Obtained insurance benefit information and pre-certification approval for surgical procedures.

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