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Quintiles Argentina - Clinical Research Associate 1 Resume Example

XXXXXXX XXXX , JENNERS , PA 15546 | (H) XXXXXXXXXXXXXX | XXXXXXXXXXXXXXXXXXXXXXXXXXX
Sofia Cox
Summary

Seasoned Clinical Research Associate 1 with more than five years of experience in fast-paced Clinical Trials Environment. Excellent communication skills (both written and oral), ability to build effective relationships with trial centre staff and colleagues & good organisational, IT and administrative skills. Track record of achieving exceptional results in principles of good clinical practice (GCP) and risk-based monitoring.

Skills
  • Critical Thinking
  • Monitoring
  • Time Management
  • Complex Problem Solving
  • Instructing
  • Learning Strategies
  • Management of Material Resources
Experience
Clinical Research Associate 1 03/2016 to Present
Quintiles Argentina Buenos Aires, CABA
  • Responsible for monitoring sponsor's initiated and federally funded clinical research studies for subjects diagnosed with Oncology Diseases.
  • Specific responsibilities include:
  • Lead monitor (CRA) mentoring and supervising other monitor(s).
  • Assist in investigator study site selection and study start-up.
  • Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.
  • Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines.
  • Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure "Good Clinical Practice", and conduct close-out visits.
  • Identify site issues and initiates correction plans based on monitoring reports.
  • Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, and project Standard Operating Procedures (SOPs), and sponsor requirements.
  • Verify data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner.
  • Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.
  • Verify drug accountability logs and storage requirements.
  • Responds to requests from investigative sites in a timely fashion.
  • Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.
Clinical Research Associate Trainee, Development Program 10/2015 to 03/2016
Quintiles Argentina Buenos Aires, CABA
  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
  • Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.
  • Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
  • Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
  • Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), CRS and/or line manager.
  • Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
  • Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Sr. Clinical Supply Specialist 05/2013 to 08/2015
PAREXEL International Vicente López, Buenos Aires
  • Actively take part in the bidding process (Proposal, 3rd Party Supplier Selection, Bid Defense, Contracts negotiation and review).
  • Define with peers in the department project material specifications regarding amount, lead times, local regulatory authorization for clinical trial material (drug and ancillary material)
  • Supports project specific sourcing and distribution strategy
  • Identify the preferred 3rd Party Supplies for defined tasks in a dedicated area in the world
  • Coordinate order placement when utilizing PAREXEL's systems
  • Gateway to Procurement and RRC for our supplier management tasks
  • Support and coordinate financial control; tracks, checks and compiles invoices.
  • Support complaint solution and audits
  • Work towards establishing positive relationships with internal and external clients.
  • Comply with Quality standards, including applicable SOPs and GxP
  • standards.
  • Travel as required by projects and Clinical Logistics Services activities.
  • Use a positive, objective, balanced, and result-driven approach.
Depot Technician (DT) 10/2012 to 05/2013
PAREXEL International Florida Oeste, Buenos Aires
  • Receive and stock of materials.
  • Prepare and distribute study documents and materials.
  • Routine cycle count or physical inventory on demand.
  • Maintain organization and cleanliness of warehouse area.
  • Pick/pack and quality control of clinical trial materials according to instructions.
  • Assistance and execution in re-labeling procedures.
  • Assistance in clinical trial materials destruction recalls and returns, with complete accountability.
  • Keep clinical trial material inventory updated daily.
  • Collect, track, check and archive shipment forms and other shipment-related communications (paper based and/or electronically).
  • Identify and reports inconsistencies concerning shipment documents or conditions.
  • Report any issue affecting quality/efficiency in a timely manner (as defined).
  • Perform quality control checks.
  • Follow relevant Clinical Research Services, Clinical Logistics Services, or Client work flows and processes.
  • Strive to contribute to external and internal customer satisfaction.
  • Participate in other Clinical Logistics Services project activities as required.
  • Track, check and compiles invoices.
  • Handle filing and archiving activities.
  • Assist in, organize and prepare Clinical Trial Materials for returns, reconciliation and destruction.
Quality Control Analyst 01/2012 to 07/2012
Laboratorios Fabra S.A. Munro, Buenos Aires
  • Assist with startup, qualification and operation of the laboratory including the development of procedures, raw material, and component testing processes, analytical methods transfer and validation, and in process and finished product release and stability testing.
  • Performance of raw material testing, inspection, in process analysis and finished product release testing.
  • In charge of maintaining the lab in accordance with SOP's, cGMPs, and INAME regulations,
  • Assist with the development and validation of analytical methods,
  • Responsible for multiple projects, and writing and revising SOP's.
Study Coordinator 05/2011 to 01/2012
Instituto Médico Especializado Alexander Fleming Buenos Aires, CABA
  • Plan and coordinate the initiation of research study protocol, and the establishment of operating policies and procedures.
  • Plan, implement, and maintain data collection and analyzing systems in support of research protocol; also coordinate the collection and analysis of research data.
  • Recruit, instruct, and coordinate of research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
  • Assure smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for internal research staff and as the principle operational liaison for other research organizations, funding agencies and regulating bodies.
  • Coordinate of day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; perform aspects of research protocol, as required, in accordance with specified program objectives.
  • Plan and coordination of staffing of research studies, include the recruitment and administration of research support staff, as appropriate to the activity.
  • Supervise and coordinate the provision of support services to investigators and researchers.
  • Monitor progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
  • Implement of quality control process throughout the conduct of the trial
  • Participate in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.
  • Perform of miscellaneous job-related duties as assigned.
Pharmacy Student 05/2010 to 05/2011
Farmacity S.A Buenos Aires, CABA
  • Dispense, prepare, label and issue drugs according to pharmacy SOPs.
  • Provide standard instructions to patients upon issuing their medications and refer to pharmacist in charge if additional information is required.
  • Restock drugs in pharmacy, wards and units and inform pharmacist in charge of unavailability of drugs.
  • Perform a regular check of expiry of drugs in pharmacy, wards and units; replace expired drugs according to pharmacy standard procedures.
  • Keep work area clean and in orderly manner and maintain the professional appearance of the pharmacy.
  • Ensure that medicinal products are stored appropriately and securely to ensure freshness and potency.
  • Ensure medication reaches the patient in the correct form and dose - this may include tablets, capsules, ointments, injections, inhalers or creams.
  • Comply with occupational health and safety at work policies and procedures.
  • Strictly maintain patient confidentiality.
  • Promote and maintain quality in all activities and ensure continuous quality improvement measures are followed
Scientific Research Intern 03/2007 to 03/2010
Faculty of Pharmacy and Biochemistry - University of Buenos Aires Buenos Aires, CABA
  • Receive and prepare laboratory samples for analysis, following proper protocols to ensure that they will be stored, prepared, and disposed of efficiently and effectively.
  • Operate laboratory equipment such as spectrometers, nitrogen determination apparatus, air samplers, centrifuges, and potential hydrogen (pH) meters to perform tests.
  • Collect samples from plants so testing can be performed.
  • Adjust testing equipment, and prepare culture media, following standard procedures.
  • Measure or weigh ingredients used in testing.
  • Prepare data summaries, reports, or analyses that include results, charts, or graphs to document research findings and results.
Education
Associate of Applied Science: Epidemiology, Biostatistics and Clinical Trials Dec 2016 Harvard Medical School - Boston, MA
  • Awarded, Harvard Medical School Scholarships.
  • Member, Associate Member of the Harvard Medical School and Harvard University Alumni Association

The Harvard Medical School Global Clinical Scholars Research Training (GCSRT) Program provides clinicians and clinician-scientists advanced training in the methods and conduct of clinical research. The blended-learning approach to this one-year program enables clinician scientists from around the world to participate.

Ph.D.: Pharmacy Apr 2016 Facultad de Farmacia y Bioquimica - Buenos Aires, CABA

Graduated with distinction.

Bachelor of Science: Biological Nov 2006 Colegio Nacional de Buenos Aires - Buenos Aires, CABA
Certifications
  • Certificate of Proficiency in English (CPE) - Cambridge English Language Assessment, 2005
  • Certificate in Foreign Languages (CLE) in French - City of Buenos Aires Government, 2003
Language
  • Native English speaker

 

  • Fluent in French & German

 

Additional Information

Certified in 

  • Dangerous Goods training based on IATA regulations, 2011
  • Introduction to Clinical Drug Development Process: ICH/FDA Good Clinical Practice for Clinical Trial Sites, 2011
  • Lean Six Sigma in the Clinical Trial Industry, 2014
  • CRA Trainee Development Program, 2015
  • Accelerated Clinical Experience, 2015
  • Site Visit Report and Follow-up Letter Writing,2015
  • Site Management Roles and Responsibilities, 2015
  • The Clinical Trial Life Cycle and When to Share Data, 2015
  • Safety Monitoring in Clinical Trials, 2015
  • Monitoring Fundamentals Application, 2016
  • Regulatory Documents: Collection, Review, Approval and Maintenance, 2016
  • Adverse Events in Clinical Trials, 2016

 

Proficient in Microsoft Word, PowerPoint, Excel, Oracle, Outlook & Stata statistical software

 

 

Personal website: https://ar.linkedin.com/in/natalia-malagrina-0562184a

Publications

Natalia Malagrina, "Polyphenols and antioxidant activity in Equisetum giganteum L. (Equisetaceae)" Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas, October 2010.

 

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Resume Details

This is a real resume for a Clinical Research Associate 1 in JENNERS, Pennsylvania with experience working for such companies as Quintiles Argentina, Parexel International, Laboratorios Fabra Sa. This is one of the hundreds of Clinical Research Associate 1 resumes available on our site for free. Use these resumes as templates to get help creating the best Clinical Research Associate 1 resume.

Previous Companies:

  • Quintiles Argentina
  • PAREXEL International
  • Laboratorios Fabra SA

Previous Job Positions:

  • Clinical Research Associate 1
  • Clinical Research Associate Trainee
  • Development Program
  • Sr Clinical Supply Specialist
  • Depot Technician

Schools:

  • Harvard Medical School
  • Facultad de Farmacia y Bioquimica
  • Colegio Nacional de Buenos Aires

Level of Education:

  • Associate of Applied Science
  • Ph.D.
  • Bachelor of Science

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