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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.
Skills
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 CurrentClinical Research Regulatory Coordinator IThe Edge Fitness Clubs | Shelby Charter Township, MI,
Regulatory
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 )
Administrative
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 12/2019Sales LeadMhc 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 08/2017Sales AssociateBryanlgh 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 11/2017Student AssistantUAB 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.
Education
Expected in 12/2020Biotechnology Regulatory Affairs Certificate | University Of Alabama At Birmingham, Birmingham, ALGPA:
Expected in 12/2018Bachelor of Science | Biomedical SciencesUniversity Of Alabama At Birmingham, Birmingham, ALGPA:
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