Sr. Coordinator, Clinical Research Program
The University of Texas MD Anderson Cancer Center
09.2015 - 01.2018
- Managed >/=100 Genitourinary protocols from initial to closing/termination.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Reviewed and prepared regulatory documentation packets for initial submissions: MDACC Institutional Review Board (IRB), FDA, Western Copernicus Group (WCG) IRB, and Central IRB (CIRB).
- Monitored the completeness and quality of Regulatory documentation including Medical Licenses, CVs, 1572, and Financial Disclosure forms (FDFs).
- Ensure clinical staff and doctors are trained in Good Clinical Practice (GCP), Human Subject Protection (HSP), and Health Insurance Portability and Accountability Act (HIPAA) compliant and department Standard Operating Procedures (SOPs).
- Submit regulatory documents through MDACC IRB, WCG IRB, and CIRB.
- Interacts and communicates with Scientific Review Committee (SRC), Investigational Pharmacy, and MDACC IRB for new protocol submissions.
- Reviewed and negotiated Informed Consent (ICFs) by MDACC Consent Editors to ensure accurate information such as site address (if applicable), side effects, and financial compensations.
- Responsible for annual Continuing Reviews and reporting new information to MDACC IRBs, WCG IRB, and CIRB.
- Updated Investigators and clinical research staff on the status of IRB submissions and resubmissions, review, approval, and regulatory documents.
- Responsible for resolving monitor regulatory queries.
- Tracked and filed documents and maintained communication between clients to manage office activities.
- Conducted meetings with Clinical Protocol Teams: Research nurses, Data Team, Principle Investigators (PI), and Sponsors to discuss/review protocol logistics, and amendments.
- Assisted with edits to protocols.
- Maintained regulatory documents in e-Reg filing via BOX, SharePoint, Teams, and file cabinets.
- Created training and Delegation of Authority (DOAs) in Prometheus.
- Tracked and managed new submissions: Protocol activation within QA protocols for internal (MDACC) or external audits: MDACC internal Monitors, Sponsors, and FDA.
- Participated in audits.
- Participated in committees to discuss electronic health records and new system methods to improve overall workflows.
- Assigned as Super User for dept.
- Responsible for completing and submitting annual Continuing
- Reviews via MDACC IRB, WCG IRB, CIRB, and Data Safety Monitoring Board Review reports.
- Prepared agenda and notes at PI meetings to archive proceedings.
- Coached colleagues through day-to-day work and complex problems.
- Office coverage for Manager.
- Worked effectively in fast-paced environments.