Denise Jordan
Chisago City
Summary
Knowledgeable Clinical Research Associate with several years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
10
10
years of professional experience
Work History
Clinical Research Associate
AbbVie
Chicago
09.2023 - Current
- Coordinated clinical trial processes to ensure compliance with regulatory standards.
- Reviewed and monitored data collection from clinical sites for accuracy.
- Prepared and maintained essential study documents throughout trial phases.
- Conducted site visits to assess adherence to study protocols and procedures.
- Trained site personnel on study protocols and data entry systems.
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
Assistant Clinical Research Associate
PPD
Minneapolis
07.2022 - 09.2023
- Completed and documented study-specific training sessions.
- Provided in-house support during pre-study assessments and assessment waivers as agreed for projects.
- Conducted remote reviews of EMR/EHR checklists and supported collection of applicable assessments.
- Assisted site staff with vendor qualification processes when necessary.
- Carried out monthly monitoring visits at study sites per study monitoring plans.
Research Administrator
Davita Clinical Research
Minneapolis
08.2019 - 07.2022
- Established and maintained strong relationships with research sites and physicians.
- Negotiated clinical study contracts, acting as liaison between DaVita legal and academic institutions.
- Oversaw all clinical study activities in dialysis facilities to ensure compliance with standard operating procedures and GCP guidelines.
- Reviewed all study materials including protocol, IRB approvals, ICF, and HIPAA documents.
Senior Administrative Assistant
Medtronic
Mounds View
10.2015 - 08.2019
- Coordinated schedules and organized meetings for senior management team.
- Arranged logistics and collaborated with vendors for successful event planning.
- Processed invoices and tracked expenses to ensure budget compliance.
- Provided comprehensive administrative support to senior management team.
- Scheduled meetings, appointments, and events for executives efficiently.
Education
MBA - Business Administration
Concordia University, St. Paul
St. Paul, MN05-2023
Bachelor of Arts - Business
Concordia University, St. Paul
St. Paul, MN05-2021
Skills
- Regulatory compliance
- Data management
- Clinical monitoring
- Study documentation
- Protocol adherence
- Vendor management
References
References available upon request.
Timeline
Clinical Research Associate
AbbVie
09.2023 - Current
Assistant Clinical Research Associate
PPD
07.2022 - 09.2023
Research Administrator
Davita Clinical Research
08.2019 - 07.2022
Senior Administrative Assistant
Medtronic
10.2015 - 08.2019
MBA - Business Administration
Concordia University, St. Paul
Bachelor of Arts - Business
Concordia University, St. Paul
Similar Profiles
Fergani Anne-ClaireFergani Anne-Claire
Quality assurance specialist at AbbvieQuality assurance specialist at Abbvie
Edgar GarciaEdgar Garcia
Set-Up Technician I at AbbVieSet-Up Technician I at AbbVie
Jacob HillJacob Hill
Clinical Drug Technician at AbbVieClinical Drug Technician at AbbVie
Gregory E. DowdGregory E. Dowd
Executive Specialty Representative at AbbVieExecutive Specialty Representative at AbbVie
Bristol LindgrenBristol Lindgren
Cashier at WalmartCashier at Walmart