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Senior Clinical Research Associate Resume Example

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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Summary

Dedicated Senior Clinical Research Associate successful at evaluating sites, initiating trials and managing closeouts. Experienced with different therapeutic areas ranging from phase I-IV, handling different protocols and overseeing multiple sites and successful at adapting to new processes. Bringing excellent organizational, planning and interpersonal skills gained during more than 6 year career.

Skills
  • Site management
  • Coordinating supplies
  • Reviewing data standards
  • Action planning
  • Planning and coordination
  • Customer service
  • Team building
  • MS Office
  • Research experience
  • Trial oversight
Experience
06/2016 to Current
Senior Clinical Research Associate Inc Research Inc Home, OK, United States
  • Conducted 100 percent site evaluations/close-out, study initiations, routine monitoring across multiply sites on different protocols and Phases-IV.
  • Communicate with site study and clinical research teams to report study site statuses, forward information to the right personnel, and resolve any issues through replying to audit results.
  • Collaboration with assigned clinical project team to ensure objectives are met.
  • Evaluated and managed documentations and information in the Clinical Trial Management System (CTMS), Trial Master File (TMF) and other systems.
  • Good documentation practices, clinical practice and Harmonisation.
  • Excellent understanding of global country/regional guidelines.
  • Contribute in sharing helpful practice tips and recommendations to CRA team as Subject matter expert (SME).
  • Assist Site with continuing to maintain patient recruitment rate.
  • Escalation of SAEs to CTM, Sponsor and IRB.
  • Advanced in MS office, Analyze Data and have Technical requirements.
  • Communicates with Investigators and site staff on issues related to protocol conduct, retention, protocol deviations, regulatory documentation, site audits/inspections, recruitment, site performance and customer Focus.
  • Coached junior Clinical research associates on study requirements, perform co-monitoring visit.
  • Ability to Set Priorities and handle multiple tasks simultaneously in a changing environment.
  • Ability to be multicultural.
  • Assist site to prepare for both internal and external audit.
  • Collaborate with site to make sure SOPs, Standard Operating Procedures is in accordance with ICH GCP and perform site management duties.
07/2014 to 06/2016
Clinical Research Associate II Clinical Research Management Frederick, MD,
  • Coordinated and monitored all stages of the conduct of clinical trials.
  • Computed all trip reports were completed to the highest quality of standards.
  • Ability to participate in continuous improvement program to enhance my growth.
  • Completed, identify and resolves site performance, quality or compliance problems and escalate appropriately to CRM, Line Manager and Project Manager.
  • Effective time management, organizational and interpersonal skills, conflict management, problem-solving skill.
  • Coordinated required documentation for the Investigator.
  • Evaluated Site files and Trial Master File (TMF) act as liaison for assigned study sites to provide product information and address issues/questions within the monitoring plans.
  • Facilitated and ensured that assigned trail sites complied with study protocol, GCP, Harmonisation, and applicable regulatory requirements for the implementation of clinical trials for optimal patient safety/adherence to protocols,.
  • Assessed and verified patient eligibility, document control violations, non- compliance, and poor performance to drive corrective action.
  • Conducting 100% site management responsibilites.
  • Conducted onsite drug accountability/reconciliation and verified that drug storage complied with protocol and SOP requirement.
  • Evaluated and analyses data/metrics and act appropriately.
  • Familiarized and manages information and documentation in CTMS, TMF.
12/2012 to 07/2014
Clinical Research Associate I Covance Sacramento, CA,
  • Maintained and required documentation for the Investigator.
  • Managed Site files and Trial Master File (eTMF).
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring & oversight activities.
  • Coordinates and act as liaison for assigned study sites to provide product information and address issues/questions within the monitoring plan.
  • Ensured that assigned trail sites complied with study protocol,.
  • Partnered with CRAs to provide a harmony of standards/procedures.
  • Performed onsite drug accountability/reconciliation and verified that drug storage complied with protocol and SOP requirement.
  • Analyzed data/metrics and act appropriately.
  • Familiarized and manages information and documentation in CTMS TMF.
  • Collects, review and monitors required regulatory documentation for study start-up, study maintenance, and study close-out, conducted site visits, including initiating, monitoring, and terminating, the investigation sites to ensure that they are complying to protocol, project plans, ICH 'GCP, and FDA guidelines.
  • Complete product accountability to track IP supplies to ensure that adequate drugs were available for the study conduct.
  • Counseled site to report to the Sponsor and IRB.
  • Analyze data validation and provide resolutions for queries.
Education and Training
Expected in 2013
Bachelor of Arts: Microbiology
Abia State Polytech - ,
GPA:
Expected in 12/2021
Master of Science: Healthcare Management: Conc. Health Informatics
Colorado Technical University - Colorado Springs, CO,
GPA:
Certifications
  • Phase I-IV Breast Cancer, Lung Cancer, Solid Tumor, Brain tumor, AML
  • Medical Device: Glucometer, Ventilator
  • Cardiovascular: Phase I-III -Hypertension, Heart Failure, Coronary Artery Disease
  • Neurology: Phase I-III Alzheimer's Disease, Multiple Sclerosis
Languages
Fluent in English
Additional Information

THERAPEUTIC AREAS

Oncology: Phase I-IV Breast Cancer, Lung Cancer, Solid Tumor, Brain tumor, AML
Medical Device: Glucometer, Ventilator
Cardiovascular: Phase I-III -Hypertension, Heart Failure, Coronary Artery Disease
Neurology: Phase I-III Alzheimer’s Disease, Multiple Sclerosis

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Resume Overview

School Attended
  • Abia State Polytech
  • Colorado Technical University
Job Titles Held:
  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate I
Degrees
  • Bachelor of Arts
  • Master of Science