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clinical research associate ii resume example with 8+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Summary

Objective: Detail-oriented and driven clinical research associate able to coordinate operations, manage sites and draft detailed reports. Knowledgeable about action planning, database locking and standard operating procedures. Desiring a challenging new role at a new company. Skilled at conducting all visit types and highly knowledgeable in ICH and GCP.

Therapeutic Experience

  • Oncology: Solid Tumor, Leukemia, Triple Negative Breast Cancer and Melanoma
  • Neurology: Huntington Disease, Autism, Multiple Sclerosis, Parkinson Disease and Major Depressive Disease
  • Rare Disease: Cystic Fibrosis
  • Ophthalmology: Dry Eye and Glaucoma
  • Medical Device: In-Vitro Diagnostics Skills
Skills
  • Over five years of clinical monitoring experience
  • Experience working in phase I, II and III of clinical trials
  • Ability to perform up to 80% of nationwide travel
  • Excellent knowledge of ICH and GCP
  • Ability to produce quality trip reports
  • Excellent communication skills
  • Experience working with Neurological rating skills
  • Experience working with Oncology rating skills
  • Ability to assimilate to change quickly
  • CTMS: Impact and iMedidata.
  • EDC: Inform 6.1, Trial Master, Medidata Rave and DataLabs.
  • TMF: Veeva Vault.
Experience
Clinical Research Associate II, 04/2017 to Current
DanaherOwasso, OK,
  • Ensure the safety of Clinical Trial subjects and the credibility of data collected by sites.
  • Perform multiple Pre-Qualification Visits, Site Initiation Visits, Routine Monitoring Visits and Close Out Visits.
  • Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
  • Verify SAE reporting according to trial specifications and ICH GCP guidelines.
  • Perform source document verification and query resolution.
  • Communicates with investigative sites.
  • Prepare Clinical monitoring tools for study team utilization.
  • Update applicable tracking systems.
  • Develop and submit accurate trip reports according to Sponsor and CRO requirements.
  • Effectively manage assigned sites and provide feedback to study team.
  • Assess IP accountability, dispensation, and compliance at the investigative sites.
  • Provide timely response to protocol/study related questions received from sites and or Clinical Team Leaders.
  • Attend and participate in Investigator’s Meeting.
  • Monitor and track patient enrollment and study progress.
  • Ensure proper reconciliation of the Regulatory Binder with the Trial Master File via frequent TMF submissions.
  • Ensure timely resolution of EDC queries and site issues according to Quintiles SOP and Sponsor SOP.
Clinical Research Associate I, 12/2013 to 04/2017
CovanceDallas, TX,
  • Participated in testing of specifications and edit checks for internal
  • Electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
  • Generated reports in various applications to assist the Clinical Trial Managers to perform clinical data review.
  • Assisted with the preparation and distribution of meeting agendas and minutes.
  • Actively participated in team meetings.
  • Communicated with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.
  • Supported and corresponded with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
  • Supported the Clinical Trial Management/operational study teams in the execution and delivery of studies.
  • Organize and maintain project working files and track critical documents.
  • Report discrepancies to the appropriate clinical team member in a timely manner.
  • Reconciled and transmitted all essential documentation to sponsor related system.
  • Tracked and assisted with processing site/vendor payments.
  • Followed up on any issues as required.
  • Collected and tracked patient enrollment information and update study management reports as necessary.
  • Monitored progress of clinical trials.
  • Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.
  • Conducted site visits to determine protocol and regulatory compliance and prepare required documentation.
  • Developed collaborative relationships with investigative sites and client company personnel.
Clinical Research Coordinator, 07/2012 to 12/2013
Broome Oncology LlcJohnson City, NY,
  • Developed in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
  • Under the supervision of the Principal Investigator (PI), prepared and submitted regulatory documents in an accurate and timely manner.
  • In collaboration with the PI, incorporated clinical judgment and knowledge of protocol to identify potential study participants per inclusion and exclusion criteria.
  • Responsible for study drug storage and drug accountability per the parameters of the study protocol and sponsor requirements.
  • Monitored and evaluated patients’ condition about the investigational product.
  • Consulted with PI regarding the appropriate administration of investigational product.
  • Conducted routine assessments to evaluate the subject’s response to investigational product, and communicated observations to the PI, sponsor and IRB as appropriate.
  • Educated the subject about the applicable study particulars.
  • Informed/updated the subject about pertinent study details as needed.
  • Documented subject information as it pertained to the clinical study per the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate).
  • Supported overall trial operation.
  • Followed up with CRO / Clinical Sites as needed.
Education and Training
B.S: Psychology, Expected in to Central State University - Wilberforce, OH
GPA:
Masters of Education: , Expected in to Antioch University Midwest - , OH
GPA:
Activities and Honors

Member of Alpha Phi Alpha Fraternity Incorporated

(2007-Present)

Member of Prince Hall Masonic Affiliates

(2010-Present)

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Resume Overview

School Attended

  • Central State University
  • Antioch University Midwest

Job Titles Held:

  • Clinical Research Associate II
  • Clinical Research Associate I
  • Clinical Research Coordinator

Degrees

  • B.S
  • Masters of Education

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