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regulatory affairs specialist resume example with 5+ years of experience

Jessica Claire
, , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - resumesample@example.com - : - -
Professional Summary

Self-motivated Clinical Research Professional with 6+ years of progressive clinical research experience within an academic medical setting, coordinating and monitoring COVID-19 and First-In-Human, phases Ia/b, phase II and phase III Oncology industry, & institutional drug trial programs to support biological and pharmaceutical development programs in a manner consistent with relevant regulations including ICH/GCP and PhRMA guidelines along with institutional SOPs. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory and compliance leadership.

Skills
  • Working knowledge of current ICH GCP guidelines and applicable regulations including 21 CFR and 45 CFR 46 of the U.S Code of Federal Regulations
  • Good knowledge of clinical research process related to study start-up and medical oncology terminology
  • Strong written and verbal communication skills to express complex ideas to study personnel, and sponsor team members.
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
  • Ability to manage multiple competing priorities within various clinical trials
  • Working knowledge of various electronic data management systems. Strong Data management skills, including REDCap database design.
  • Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor junior staff
  • Strong time management/project management skills
Work History
04/2021 to Current
Clinical Research Manager Abbott Laboratories Charlottesville, VA,
  • 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.
  • Collected data and followed research protocols, operations manuals and case report form requirements.
  • Followed informed consent processes and maintained records.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
01/2019 to 04/2021
Clinical Research Associate Christensen Farms Heron Lake, MN,
  • Acts as liaison with Clinical Monitoring, Contracts team, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
  • Coordinates all aspects of protocol submission for research projects. Prepares and submits all necessary documents to the Institutional Review Board (IRB) and ancillary committees.
  • Works with the research team to facilitate the enrollment of research subjects in compliance with established regulations and guidelines.
  • Reviews and confirms subject eligibility and regulatory compliance for enrollment. Submits eligibility exceptions to the IRB
  • Prepares and submits all regulatory documents to sponsor and/or contract research organization (CRO).
  • Creates, reviews, and customize site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
  • Coordinates the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, MDs, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required.
  • Ensures maintenance of up-to-date regulatory records and compliance with industry deadlines.
  • Provides training to junior and new staff on subject registration and regulatory processes and procedures.
  • Maintains and disseminates accurate listings of active and potential studies to participating investigators.
  • Reports all Serious Adverse Events (SAEs) to the Institutional Review Board and other agencies, as required
  • Serves as the resource for detailed information on assigned protocols and other investigational research activities
10/2018 to 11/2019
Research Site Manager Iqvia Holdings Inc Blacksburg, VA,
  • Prepared and submitted document packages to central IRB/EC, protocol amendments and annual reviews
  • Performed essential document collection and review, maintenance and close out, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Screened patient records, database physician referrals to identify prospective candidates for research studies.
  • 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.
03/2017 to 01/2019
Sr. Clinical Research Coordinator University Of Miami Miller School Of Medicine Hollywood, FL,
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Initiate and coordinate over 40 research trials to ensure compliance with protocols and Good Clinical Practices (GCP)
  • Organized and manage regulatory documentation (i.e., IRB submissions, SAE reporting, maintain and update CVs and medical licenses).
  • Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
  • Perform all subject laboratory assessments like EKG, sample collections, phlebotomy, vital signs, urinalysis, and shipments per biosafety guidelines.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Collected data and followed research protocols, operations manuals and case report form requirements.
  • Coordinates the recruitment and enrollment of study participants. Assesses patient eligibility for inclusion in clinical trials. Ensures proper consent protocols have been followed for study participation.
10/2015 to 03/2017
Clinical Research Coordinator Company Name City, State,
  • Initiated and coordinated over 25 studies to ensure compliance with protocols and Good Clinical Practices (GCP)
  • Perform all aspects of study planning including developing source documents, standard operating procedures (SOP’s), working with and completing electronic case report forms (eCRF’s), recruiting subjects, interacting with study monitors and sponsors.
  • Organize and manage regulatory documentation (i.e., IRB submissions, grants and contracts, serious adverse event reporting, maintain and update CVs and medical licenses).
  • Screen patients for eligibility and monitor patients for medical complications, potential drug interaction and other adverse effects.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Perform all subject laboratory assessments like EKG, sample collections, phlebotomy, vital signs, urinalysis, and shipment per biosafety guidelines.
Education
Expected in 05/2020 to to
Master of Science: Clinical Research Organization And Management
Drexel University - Philadelphia, PA
GPA:
Expected in 06/2017 to to
Certificate: Clinical Research Management
Sollers - Edison, NJ,
GPA:
  • Graduated in Top 5% of Class
  • Dean's List 2017
Expected in 12/2016 to to
Certified Medical Assistant: Medical Assisting
Allen School - Jamaica - Jamaica, NY
GPA:
  • Graduated summa cum laude
Expected in 07/2013 to to
Bachelor of Science: Business Management
University Of Buea - Cameroon,
GPA:

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Resume Overview

School Attended

  • Drexel University
  • Sollers
  • Allen School - Jamaica
  • University Of Buea

Job Titles Held:

  • Clinical Research Manager
  • Clinical Research Associate
  • Research Site Manager
  • Sr. Clinical Research Coordinator
  • Clinical Research Coordinator

Degrees

  • Master of Science
  • Certificate
  • Certified Medical Assistant
  • Bachelor of Science

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