Jana Hall Email & Phone Number

United States

Durham, Nc

Durham, Nc

Regulatory Coordinator in GYN Clinical Research Unit. Perform regulatory and safety processes for oncology clinical trials and research studies. Help with data entry and lab kits.- Submit Institutional Review Board (IRB) documents such as consent forms, protocols, andcontinuing reviews for ongoing studies and startup initial IRB submissions for new studies. Complete and submit Adverse Events Reports. - Maintain study level documentation to include regulatory binders, Advarra eReg,… Show more Regulatory Coordinator in GYN Clinical Research Unit. Perform regulatory and safety processes for oncology clinical trials and research studies. Help with data entry and lab kits.- Submit Institutional Review Board (IRB) documents such as consent forms, protocols, andcontinuing reviews for ongoing studies and startup initial IRB submissions for new studies. Complete and submit Adverse Events Reports. - Maintain study level documentation to include regulatory binders, Advarra eReg, iMedRIS, and OnCore.- Work closely with sponsors on regulatory and safety issues. Prepare for study monitoring visits and schedule monitor visits to access EMR (Epic) and eReg.- Utilize Epic to assist with EDC data entry thru eCRF portals. Prepare lab kits for study visits. Show less

Chapel Hill, North Carolina, United States

Chapel Hill, Nc

Lineberger Comprehensive Cancer Center has established and is establishing relationships with community practices, neighboring institutions, and sites across the United States to partner in LCCC investigator initiated trials (LCCC IIT). This position is responsible for overseeing regulatory compliance of LCCC IITs conducted at multi-center sites. Uses planning, organizing, and evaluation to ensure LCCC studies adhere to applicable regulations and LCCC SOPs. Monitors and provides technical… Show more Lineberger Comprehensive Cancer Center has established and is establishing relationships with community practices, neighboring institutions, and sites across the United States to partner in LCCC investigator initiated trials (LCCC IIT). This position is responsible for overseeing regulatory compliance of LCCC IITs conducted at multi-center sites. Uses planning, organizing, and evaluation to ensure LCCC studies adhere to applicable regulations and LCCC SOPs. Monitors and provides technical assistance in regulatory compliance to multi-center sites. Provides consultation and leads exchange of research information. Coordinates LCCC studies for the life of the trial, from startup to close-out. Collects, reviews, approves, and maintains essential documents for the multi-center sites. Ability to prioritize work when multiple projects are at hand. Understanding of deviations, violations, UPIRSOs, SAEs, and IND safety reports.• Responsible for UNC IRB submissions when site uses this IRB. Distribute approved documents to sites and maintain electronic records at UNC.• Collect and maintain IRB approval letters and approved documents from sites when using other IRBs.• Responsible for sending sites UNC IRB approved documents and relaying relevant information.• Act as sponsor to review and approve informed consents from sites prior to IRB submission.• Utilize OnCore database to record staff information (contact info, CVs, MLs, GCP and Human Subjects Research training), site information, laboratory information (CAPs, CLIAs, normal reference ranges), and IRB approvals with approved documents. Show less

Chapel Hill, Nc

Gather, edit, analyze, and report data/information for the purpose of communicating with the Institutional Review Board (IRB) and research sponsors. Comply with federal, state, and local laws, regulations, and guidance's applicable to the conduct of oncology clinical research. Participate in the collection, compilation and management of data/information; quality assurance and quality control; analysis; generation/production of new data/information; editing and formatting of reports.

Experienced caring for elderly family member with disabilities. Areas of responsibility include:- Housekeeping- Meal preparation- Errands and appointments- Grocery shopping- Companionship- Managed sell of home and move to new location- Managed remodeling project to accommodate disabilities- Financial oversight and management

Morrisville, Nc

Manufacturing Associate Engineer (3/2013 – 6/2014)Worked within manufacturing team to build and test cartridges utilizing proprietary digital microfluidics technology that performed many bioassay protocols. cGMP cleanroom and BSL2 laboratory certified.Manufacturing Technician (1/2012-3/2013)Performed duties of cleaning, microscopic inspection, testing, and bonding of components used to fabricate cartridges. Followed and adhered to all standard operating procedures.

Morrisville, Nc

Biorepository banking for company that provided clinical pharmacogenomics services for drug development programs. Gained experience in sample accessioning area receiving blood, plasma, and other samples for DNA testing and biorepository. Completed 384 hours of fieldwork experience. • Maintained chain of custody of all samples, labeled, and logged into LIMS freezer database.• Successfully completed training on GCP, GLP, Blood Borne Pathogens, HIV, Chemical Safety, and Biosafety.

Chapel Hill, Nc

Worked in the breast and hematology oncology groups to gain experience on the responsibilities of a clinical research associate. Completed 256 hours of fieldwork experience.• Completed case report forms (CRFs), both paper and electronic. Graded adverse events. Verified patient eligibility for a study.• Became knowledgeable with UNC’s patient records database, Webcis, and their protocol database, OnCore.• Successfully completed training on HIPAA, GCP, and Biomedical research training.

Research Triangle Park, Nc

Process Engineer (2004 – 2009)Performed sustaining functions in Wet Sector of microelectronics cleanroom to troubleshoot nonconforming product issues on solder bumped semiconductor wafers. Involved in research and development experiments to improve product and processes. - Successfully developed and completed experiments to troubleshoot a scrap lot event. Completed corrective action report and implemented changes to prevent scrap from reoccurring which resulted in improved process and… Show more Process Engineer (2004 – 2009)Performed sustaining functions in Wet Sector of microelectronics cleanroom to troubleshoot nonconforming product issues on solder bumped semiconductor wafers. Involved in research and development experiments to improve product and processes. - Successfully developed and completed experiments to troubleshoot a scrap lot event. Completed corrective action report and implemented changes to prevent scrap from reoccurring which resulted in improved process and customer satisfaction.- Dispositioned nonconforming material and implemented rework procedures promptly which resulted in meeting schedules and cycle time goals.- Participated and presented at engineering meetings with data collection results that substantiated process improvements efforts.- Optimized throughput at two specific bottleneck processes that increased capacity by 50% (cupro etch and semitool strip).- Performed management role of wet sector leader from 2005 – 2007. Supervised one engineering technician. Conducted team meetings for all area technicians. Compiled information and presented bi-monthly PowerPoint presentations of issues such as scrap, wafer breakage, misprocesses, and reviewed new or revised procedures.- Evaluated SPC data daily using WinSPC software and responded to out of control conditions.Associate Engineer and Process Technician (2002 – 2004)Operated wet bench equipment and automated toolsets to process lots in a timely manner following standard operating procedures. - Trained new technicians and engineers in their job responsibilities.- Promoted from process technician to associate engineer. Show less

Research Triangle Park, Nc

Research Triangle Park, Nc

Durham, Nc

Durham, Nc

Research Triangle Park, Nc

Associate In Applied Science, Clinical Trials Research Associate, Gpa 4.0

Activities and Societies: Phi Theta Kappa Honor Society Graduated with highest honors.

Associate In Applied Science, Electronics Engineering Technology, Gpa 3.8

Activities and Societies: Alpha Theta Tau Honor Society

University Transfer Courses

Education record