Technical Operations Analyst Resume

Objective:To obtain a position in the field of clinical research and clinical trial management.

Summary of Qualifications

Recent Fundamentals of Clinical Research training
Successful completion of ACRP Core Knowledge Assessment (CKA) Testing.
ICH and GCP knowledge
3 years of Clinical Research Reference Laboratory expertise in Phase II-IV clinical trials
Global and Domestic clinical trial experience
14 years pharmaceutical industry experience
FDA GMP audit experience
Ability to work as part of a team or independently
Fully bilingual in English and Spanish
Excellent organization skills

Therapeutic Experience: Oncology; Endocrine/Metabolic; Immunology; Musculoskeletal; CNS/Psych; Neurology; Infectious Disease and Respiratory in Drug Phases II-IV.

Education

Bachelor Degree in Microbiology

Professional Experience

November 2010 November 2011 Confidential,
Technical Operations Analyst II- Project Management Operations

Reviews Phase II IV protocols to set-up and program data base with rules and edit checks for safety.
Monitors and manages all aspects of designated clinical trials protocols and accountable for overall project performance.
Reviews and interprets protocols and corresponding budgets in consistency with current standards and/or sponsor specifications.
Meets with study teams on a regular basis and maintains effective communication to ensure study design is accurate at all times.
Serves as consultant and client interface during database set up, modification and approval.
Assist the Project Manager to ensure all tasks and accountabilities are carried out in a timely and effective manner.
Communicates effectively within multi-disciplinary project team to complete assigned tasks on time and within budget.
Interacts with clients in relevant meetings and audits.

September 2008 October 2010 Confidential,
Support Investigator

Remotely monitor laboratory data and communicate issues to clinical monitoring team in order to provide resolution.
Assist with questions or problems regarding research protocols in USA and Latin America.

March 2002 June 2008 Confidential,
Validation Consultant

Responsible to review SOPs vs. actual system condition and make recommendations for laboratory, manufacturing and engineering areas based on reviews.
Development and Execution of Protocols for the Cleaning Validation Area including sampling and testing plan for different products.
Provide technical support to the manufacturing and validation areas. Coordinate trainings.

March 1997- May 2001 Confidential,
Microbiologist

Performed varied quality tests to water, food and drug samples.
Audited and corrected test documentation for quality control.
Performed Microbiology Laboratory Investigations.

December 1996- March 1997 Confidential,
Microbiologist

Processed samples from the environmental laboratory to ensure quality control standards.

Computer Skills:

Windows, Word, PowerPoint and Excel

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship