Certified clinical research professional highly experienced in data management and early phase clinical trials. Seeking a management position that offers professional challenges and allows me to utilize my breadth of knowledge in clinical research, while also adding to it.
· Manage data entry for Phase I oncology trials, including first in human studies across different disease groups
· Efficiently prioritize over 15 active studies in data entry/query resolution to meet data cut timelines
· Develop source documents to reflect study protocol and help complete electronic case report forms
· Collaborate with research nurses and various clinical departments to ensure study procedures are completed per protocol requirements
· Communicate with CRAs during monitor visits and ensure data is updated in a timely manner
· Develop Phase I specific Data Management guidance documents and assist in onboarding new hires on the team
· Pre-screen and assist with screening and enrollment of new subjects
Review medical records for internal and external referrals to present at weekly E-ATTACK meetings for potential trial eligibility
· Completed and submitted continuing review and amendments to IRB for investigator initiated clinical trials
· Developed and completed case report forms for various studies
· Recruited study participants and accompanied them to their SPECT scan and fMRI appointments
· Conducted Mini Mental Status Examination for study participants and oversaw that study participants completed study questionnaires
· Ensured that all appointments were confirmed and participant charts were updated as needed
Early Phase Trials
First in human trials
Oncology
Clinical Research
Data Management
Protocol Review
Participant screening
Good Clinical Practices
Documentation Management
Electronic Data Capture
Adverse event reporting
Clinical Research Ethics
Research experience
Data Entry