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clinical research associate ii resume example with 10+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
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Summary

Accomplished Clinical Research Associate with over 8 years experience in global and national studies in different Therapeutic Areas such as: Respiratory, CNS Neurology, Gastroenterology, Cardiovascular and Oncology. I have monitored studies with pediatric and adult population. I have monitored diverse aspects of clinical monitoring including sites selection, and monitoring activities in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. I have performed Pre-Study Visits, Site Initiation Visits, Monitoring Visits and Close-out Visits. Overall, I am a very motivated and independent CRA with strong organizational, documentation, presentation and interpersonal skills. SUMMARY OF EXPERIENCE/SKILLS 4 years’ experience in site management & monitoring of clinical trials. Experience monitoring global studies (Phases I – III) from study start-up site selection visit to maintenance phase and close-out. Good knowledge of ICH-GCP guidelines. Internal and sponsor audits. Strong leadership and interpersonal skills.

Skills

Computer Skills:

  • MS Word, Outlook, Excel, PowerPoint, Access & One Note.
  • Proficient in the usage of EDC/ECRF – GCP, Medidata Rave & Inform, CTMS – Impact & Siebel, IWRS – Bracket & BioClinica, ETMF – Veeva Vault,
  • IRB, FDA, CRA, CRF, CRO, IV
  • CLINICAL trial protocol, Site Study,
  • Site Management, Data Management
  • Clinical Research, Regulatory Submissions
  • Site Monitoring, Consent Forms, Oncology
  • Experience with Research Protocols and regulatory or governing bodies which includes HIPAA and FDA regulations
  • Experience in Device development, project management, Pharmaceutical industry, Global Trials
  • Basic understanding of the drug accountability process
  • Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Knowledge of local requirements for real world late phase study designs
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
  • Excellent knowledge of Good Clinical Practice (GCP) and also good working knowledge of conducting clinical trials
  • Project management experience including the ability to prioritize, plan & evaluate deliverables and ensure compliance
  • Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures, Biotechnology, Medical therapeutic, Medical Terminology and Audit experience, Clinical Laboratory,
  • Good planning, organization and problem-solving abilities; Ability to work with minimal supervision or with a team
  • Excellent interpersonal, written and oral communication skills.
  • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and guidelines.
  • Flexibility and ability to travel routinely to meet project requirements.
  • Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
  • familiar with Institutional Review Board activities and Institutional Biosafety Committee actions
  • FDA-regulated drug/vaccine clinical trial monitoring experience
  • Working knowledge of medical specialties; working knowledge of federal and military regulations regarding the use of human and animal subjects in research
  • 8 years of onsite clinical research monitoring experience
  • Experience in phases I-IV clinical
  • trials.
  • ability to learn new, clinical systems
Experience
Clinical Research Associate II, 02/2018 - Current
Dermtech, Inc. Dallas, TX,
  • Recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develop action plans
  • Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
  • (performed on-site or remotely) qualification, site initiation, interim monitoring, site management activities and close-out visits
  • Verifies the process of obtaining informed consent has been adequately performed and documented and ensure site staff demonstrates diligence in protecting the confidentiality of subject/patient
  • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP), Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical record
  • Verifies required clinical data entered in the case report form (CRF) is accurate and complete and apply query resolution techniques remotely and on site
  • Provide guidance to site staff as necessary, driving query resolution/quality compliance issues to closure within agreed timelines
  • Utilizes available hardware and software to support the effective conduct of the clinical study data review and verifies site compliance with electronic data capture requirements
  • Perform investigational product (IP) inventory, reconciliation and reviews storage and security
  • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
  • Verifies issues or risks associated with blinded or randomized information related to IP
  • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
  • Reconciles contents of the ISF with the Trial Master File (TMF)
  • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
  • Supports subject/patient recruitment, retention and awareness strategies
  • Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
  • Understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
  • And adapting quickly to changing priorities to achieve goals / targets
  • Act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate
  • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
  • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
Clinical Research Associate II, 01/2018 - 01/2019
Dermtech, Inc. Northern New Jersey, NJ,
  • Reviewed data queries and listings and worked with study centres to resolve data discrepancies
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
  • Liaised with clinical project leader to effectively resolve study-related issues
  • Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues
  • Maintained Site Monitoring schedules to facilitate effective communication with members of clinical team
  • Coordinated and scheduled protocol related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Clinical Research Associate I, 09/2015 - 12/2018
Danaher Allentown, PA,
  • Communicated with physicians and practitioners for patient care concerns to obtain orders and intervention protocols
  • Adhered to good clinical practices, operating procedures and regulatory requirements.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Obtained site approval and compiled all vital documentation.
  • Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
Clinical Trial Coordinator, 02/2012 - 08/2015
Cognizant Technology Solutions Santa Clara, CA,
  • Screened patient records, databases and physician referrals to identify prospective candidates for research studies
  • Maintained compliance with protocols covering patient care and clinical trial operations
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
  • Collected data and followed research protocols, operations manuals and case report form requirements.
Education and Training
Master of Arts: Human Resources Development, Expected in 06/2020
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Bowie State University - Bowie, MD
GPA:
Status -
Master of Science: Public Health, Expected in 10/2010
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University of Nigeria - Nigeria,
GPA:
Status -
Bachelor of Science: Biomedical Sciences, Expected in 08/2008
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University of Nigeria - Nigeria,
GPA:
Status -
: , Expected in
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Project Management Professional (PMP)® - ,
GPA:
Status -
Accomplishments
  • Central Nervous System-Schizophrenia (Phase III).Cardiovascular- Pulmonary Hypertension- (Phase II), Management of Hyperkalaemia in Heart Failure (Phase IIIb)
  • Oncology-Non -Small Cell Lung Cancer (Phase I), Ovarian Cancer (Phase III)
  • Metabolic Disorders- Diabetes (Phase II)
  • Gastroenterology- Ulcerative Colitis (Phase IIb)
  • Respiratory- Symptomatic Respiratory Illness in elderly (Phase III)
  • Idiopathic Pulmonary Fibrosis- (Phase Ib)
  • COVID-19 Vaccine Adult/Adolescent –(Phase II/III)
  • Dermatology-Prurigo Nodularis –(Phase 3b)
  • Endocrine System- Polycystic Kidney Disease in children and Adolescent -(Phase IIIb).

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Resume Overview

School Attended

  • Bowie State University
  • University of Nigeria
  • University of Nigeria
  • Project Management Professional (PMP)®

Job Titles Held:

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

Degrees

  • Master of Arts
  • Master of Science
  • Bachelor of Science

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