Medina Oskey
Madison
Summary
Focused Clinical Research Coordinator with experience in applying clinical research regulatory requirements such as GCP and ICH guidelines. Well-versed in study protocols, standard operating procedures and general trial oversight. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Ready to bring 3 years of related experience to a new clinic. Exemplary educational qualifications include a Bachelors of Science in Biology from the University of Wisconsin. Excellent problem-solving abilities with a meticulous regard for detail and a strong follow-through.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Fortrea Clinical Research Organization
10.2022 - Current
- Worked with principal investigator and sponsors to facilitate daily trial activities and complied with research protocols.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Participated in site initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Lab Technician II
Labcorp Drug Development
09.2021 - 09.2022
- Recognizes deviations from expected results and follows up appropriately
- Communicates necessary information with sponsors, monitors, patients, physicians, co-workers, and others in a courteous and professional manner
- Exhibits an ability to work in a collaborative, effective manner with all necessary research team members in order to meet the research objectives
- Processes and ships PK samples according to study specific instructions
- Performs phlebotomy as needed
- Participates in the collection of biological specimens
- Evaluates and solves problems related to the collection and processing of specimens
- Inventories reagents and supplies to ensure uninterrupted operations
- Handles hazardous materials, reagents and chemicals in a safe manner in accordance with laboratory policy and procedure
- Assists in training staff members on new lab procedures and accurate source documentation
- Supports and participates in Corporate and Department initiatives regarding quality system implementation, maintenance, and continuous quality improvement activities.
Research Technician II
Labcorp Drug Development
08.2021 - 09.2021
- Accurately performed ECG’s, blood pressure, pulse, respiratory rates and weights
- Collection and processing of biological samples as specified in the protocol and ensures the proper distribution of those samples
- Performs phlebotomy as needed
- Foster respectful relationships with study participants
- Assist with training of new staff
- Maintains skills to perform all study tasks, as required
- Maintains constant awareness of participant safety and dignity at all times
- Maintains an understanding of current regulatory requirements.
Case Report Form Specialist I
Labcorp Drug Development
02.2021 - 08.2021
- Transcribe study data into electronic case report form
- Enter data into the computer using current data management software
- Work in conjunction with quality control and project manager to ensure that case report form completion timelines are met
- Work with sponsors during monitoring visits to ensure all data questions and clarifications are answered
- Timely follow-up and resolution to all sponsor generated data queries
- Continuously look for ways to improve the efficiency and quality of unit work processes
Education
Bachelor of Science - Biology, Allied Health Foundations
University of Wisconsin
Skills
- Protocol Compliance
- Clinical Trial Procedures
- Subject Recruitment & Screening
- Case Report Forms
- Documentation Maintenance
- ICH/GCP Guidelines
- HIPPA Regulations and Guidelines
- Customer Service
- Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Collection of Specimens
- Laboratory Preparation
- Lab Safety
Certification
Completion of a Certified Clinical Research Coordinator (CCRC) training program (CITI Training)
Timeline
Clinical Research Coordinator
Fortrea Clinical Research Organization
10.2022 - Current
Lab Technician II
Labcorp Drug Development
09.2021 - 09.2022
Research Technician II
Labcorp Drug Development
08.2021 - 09.2021
Case Report Form Specialist I
Labcorp Drug Development
02.2021 - 08.2021
Bachelor of Science - Biology, Allied Health Foundations
University of Wisconsin
Completion of a Certified Clinical Research Coordinator (CCRC) training program (CITI Training)
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