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senior clinical research associate resume example with 10 years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Professional Summary

Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 9+ years of related experience to a challenging new role.

Skills
  • 9+ years of Site Management experience
  • Experience working with multi-functional Project teams
  • Knowledge of ICH, and local regulatory authority regulations
  • Experience in Monitoring all trials component (PSSV, COV)
  • Computer proficiency in microsoft office
  • Excellent Communication skills
  • Ability to travel (Greater than 70%)
  • Excellent attention to details
  • Experience working in Phases I-III Clinical Trials
  • Good Clinical Practices
Education
Ross University School of Medicine Dominica Republic, Expected in 11/2009 M.D. : Medicine - GPA :
Universidad Autonoma De Guadalajara Jalisco, Mexico, Expected in 06/2006 M.D. : Medecine - GPA :
Work History
Abbott Laboratories - Senior Clinical Research Associate
Mesa, AZ, 07/2019 - Current
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Assist with submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
  • Participates in preparing and reviewing study documentation and feasibility studies for new proposals as required
  • Manages sponsors generated queries efficiently and responsible for study cost effectiveness
  • Assists in training and mentoring less experienced CRAs
  • Maintains strong working knowledge of protocols and monitoring plans for assigned projects
  • Verifies that investigator, staffs, and site facilities remain adequate throughout the trial
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Gathered, processed and shipped lab specimens.
Bio-Rad Laboratories - Clinical Research Associate II
Ann Arbor, MI, 01/2016 - 07/2019
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
Endologix - Clinical Research Associate
Irvine, CA, 08/2014 - 01/2016
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
  • Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Observed clinical studies and assessed health outcomes in groups of participants to support research plan.
Minnesota Gastroenterology - Clinical Research Coordinator
Coon Rapids, MN, 10/2011 - 08/2014
  • Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
  • Collected data and followed research protocols, operations manuals and case report form requirements.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
  • Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
  • Monitored company inventory to keep stock levels and databases updated.

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Resume Overview

School Attended

  • Ross University School of Medicine
  • Universidad Autonoma De Guadalajara

Job Titles Held:

  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate
  • Clinical Research Coordinator

Degrees

  • M.D.
  • M.D.

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