Semret Ghebrehiwet
Clinical Research Professional
Orlando,FL
Summary
Focused Clinical Research Professional well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 9 years of related experience as Clinical Data Specialist and Clinical Regulatory Associate to a challenging new role.
Overview
10
10
years of professional experience
Work History
Clinical Research Regulatory Associate
Orlando Clinical Research Center
Orlando, FL
11.2019 - Current
- Maintain required documentation for clinical studies at the site, and for GCP and FDA compliance.
- Obtaining and storing required clinical study documentation for each study.
- Record, organized and maintain necessary study data, study correspondence, and applicable logs.
- Coordinate with Regulatory Manager regarding regulatory and compliance practices.
- Participate in interactions with Ethics Review Boards, Sponsors, CRO's and clinic staff.
- Prepare draft study documents (informed consents, phone screens, etc.), assembles and reviews various documents (i.e. FDA Form 1572, CV's, Lab Certifications, etc.) in preparation for study submission.
Clinical Data/QC Specialist
Orlando Clinical Research Center
Orlando, FL
07.2012 - 11.2019
- Develop a thorough working knowledge of protocols assigned.
- Assist Clinical Research Coordinators (CRC) in completing Case Report Forms (CRF's) for the study accurately and completely.
- Entry of data for all paper and electronic CRF's and remote data entry.
- Facilitate and ensure all data queries are being addressed and entered in a timely manner.
- Review/QC source documents and CRF's prior to monitor visits.
- Assist CRC in corrections and data queries.
- Assist CRC in the participation of audits when necessary.
- Participate in QC of source documents and CRF's and preparation for audits.
- Identify non-conformances with requirements and provide suitable recommendations.
- Assist in the training and orientation of data staff.
- Assisted with database upgrades and migrations by performing user acceptance testing.
Provider Services Specialist
Rotech Healthcare Inc
Orlando, FL
01.2012 - 06.2012
- Complete all Medicare and/or Medicaid applications accurately and timely, including but not limited to enrollments, change of addresses, etc.
- Document all conversations with field personnel related to provider number status.
- Inform manager of any issues or problems related to the provider number status.
- Maintain provider services files.
- Follow up on outstanding issues consistently to ensure timely filing of applications.
- Maintain activity log.
- Provides administrative assistance to the Provider Services Manager.
- Maintain confidentiality of compliance and all other pertinent information.
- Other duties as may be required or assigned.
Education
High School Diploma -
William R. Boone High School
Orlando, FLAssociate of Science - Health Information Technology
Valencia College
Orlando, FL09.2023
Skills
- Administrative
- Data Entry
- Clinical Trials and Research
- Discrepancy Management
- Time Management Skills
- Organized and Detail-oriented
- Regulatory Compliance and Documentation
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Don’t believe everything you think.
Byron Katie
Timeline
Clinical Research Regulatory Associate
Orlando Clinical Research Center
11.2019 - Current
Clinical Data/QC Specialist
Orlando Clinical Research Center
07.2012 - 11.2019
Provider Services Specialist
Rotech Healthcare Inc
01.2012 - 06.2012
High School Diploma -
William R. Boone High School
Associate of Science - Health Information Technology
Valencia College
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