Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000,
Professional Summary

Knowledgeable Clinical Research Regulatory Coordinator I adept at managing regulatory documents for study trial and GCP and IRB regulatory compliance regulations. Highly organized and thorough with good planning and problem-solving abilities. Certified in Biotechnology regulatory affairs.

  • Strong attention to detail, good organizational skills and the ability to prioritize with changing situations
  • Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines
  • Ability to handle confidential information in a professional manner
  • Detailed oriented and highly self-motivated
  • Excellent interpersonal skills including excellent verbal and written communication skills
  • Attention to Detail: Consistently displays accuracy and attention to detail
  • Strong attention to detail
  • Ability to deal with sensitive, confidential and regulatory matters
  • Good computer skills including but not limited to the knowledge of a Clinical Trial Management Systems (such as IRAP, Oncore, and CTSU)
  • Significant clinical trials experience ideally in Study Start Up and study trial regulatory maintainence
Work History
08/2019 to Current Clinical Research Regulatory Coordinator I The Edge Fitness Clubs | Shelby Charter Township, MI,


  • Coordinate and implement regulatory and Institutional Review Board (IRB) activities as required in the management of site clinical trials research involving the collection, and documentation of regulatory processes
  • Manage regulatory documents such as IRB approvals, sponsor memos, safety reports, statistical reports, adverse events, and ancillary IRB regulatory documents electronically and in the study binder.
  • Prepare and submit IRB applications to open and maintain Regulatory documentation and submission for Cooperative Group studies such as Alliance, NRG, and RTOG Studies.
  • Update OnCore with IRB approvals and amendment
  • Obtain principal investigator's signature for study trial regulatory documents
  • Maintain study trial delegation of responsibility logs and meeting attendance
  • Correspond with study sponsors and other regulatory personnel
  • Submit IRB personnel contact update forms
  • Submit and ship FDA IND Application Forms (e.g., Form 1571, FDA Form 1572, and Form 3674 )


  • Complete and submit pharmacy and hospital invoices for the clinical trials
  • Assist the clinical coordinators, research nurses, and other hospital staff with clinical trial regulatory compliance
  • Prepare and maintain consent wall folders with copies of the latest IRB approved consents for the ease of physicians seeking to enroll patients.
  • Ensure that physicians are current on their IRB training and CTEP and NCI RCR registration
  • UAB Hospital Study Trial Invoices and UAB Patient Financial Services UAB Hospital Internal Payment Form and UB
  • Update Cooperative Group Trials monthly accrual documents for submission
  • Coordinate UAB Department of Radiation Oncology Science Hour presentations
  • Complete and submit Research Summary Forms for IMPACT Banners.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
11/2014 to 12/2019 Sales Lead Mhc Equity Lifestyle Properties | Amboy, IL,
  • Act as a partner between customers, sales associates, Assistant Manager and the Store Manager
  • Assist manager in motivating fellow employees, keeping them engaged and working as a cohesive team
  • Assist with loss prevention efforts by providing proactive customer service
  • Assists in the delegation of work, determining the method of work, giving clear and concise direction, and follow up to ensure proper execution
  • Send cooperate emails to the District Manager detailing store performance and other operational information
  • Log store performance reports, file company documents, perform manager overrides and other managerial tasks
  • Calculate store performance values and interpret the results for the company
  • Answer phone calls
  • Verify bank deposit logs for accuracy filed in a locked and secure designated safe
  • Create action plans for sales associates to ensure that associates are informed of how to efficiently work to make sales goals.
06/2017 to 08/2017 Sales Associate Bryanlgh Medical Center | Lincoln, NE,
  • Achieve or exceed personal sales goals as established by the Store Manager and develop a complete knowledge of the merchandise
  • Directs guest requests to the Assistant Store Manager/Store Manager
  • Monitor the sales floor while maintaining store visual standards and assisting customers
  • Perform other related job duties as assigned by store management
08/2014 to 11/2017 Student Assistant UAB Athletics Department | City, STATE,
  • As a student assistant, my duties were to assist the athletic trainers in transporting medical equipment and other supplies.
  • Communicated with athletes to ensure proper treatment was given.
  • Gave physicals which included a vision screening and balance test.
  • I monitored the athlete’s physical condition.
  • Assisted in office opening and closing.
  • I typed in treatments through a program to better help athletic trainers monitor athlete’s treatment type and date treatment was given.
  • If needed, I taped athlete’s ankles before practices and games.
Expected in 12/2020 Biotechnology Regulatory Affairs Certificate | University Of Alabama At Birmingham, Birmingham, AL GPA:
Expected in 12/2018 Bachelor of Science | Biomedical Sciences University Of Alabama At Birmingham, Birmingham, AL GPA:

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Resume Overview

School Attended

  • University Of Alabama At Birmingham
  • University Of Alabama At Birmingham

Job Titles Held:

  • Clinical Research Regulatory Coordinator I
  • Sales Lead
  • Sales Associate
  • Student Assistant


  • Biotechnology Regulatory Affairs Certificate
  • Bachelor of Science

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