Jeff Putney

Performs data entry and accurate record keeping of source documents for several of our Phase 1 clinical trials in the Developmental Therapeutics Medical Oncology department.

Working knowledge of several different EDCs such as Medidata Rave, Veeva, Medrio and more. Efficient at all data entry tasks and query resolution.

Works closely with CRAs and Sponsors to facilitate monitoring visits, PI calls, and any correspondence regarding patient data and filing of regulatory documents.

Responsible for making sure protocol requirements are being accurately met for our Phase 1 trials, such as assessments, patient eligibility, informed consent, and reporting of any protocol deviations.

Maintaining up to date certifications and applications of ICH and GCP best practices along with a vast knowledge of reporting timelines regarding FDA guidelines.

Participates in interviewing and training new hires for the sample coordinator role, that i previously piloted, for other disease teams within our Medical Oncology department.

Spearheaded a new role within the Phase 1 Developmental Therapeutics department designed to effectively manage all sample related activities of our more than 40 active Phase 1 clinical trials.

Developed, implemented and trained the team on the sample tracking system that i helped create, in order to accurately and efficiently log all of the samples that are being collected from our Phase 1 patients.

Made sure all samples were being collected, stored and shipped per protocol requirements. Created and updated new and existing source documents when needed.

Received all incoming kit shipments and was responsible for disposing of all expired kits according to our site's SOPs.

Collaborated closely with multiple internal departments including: Heme lab techs, radiology techs, treatment nurses and pathologists to address challenges and improve processes in real time.

Lead technician of a quality team of 5+ employees, ensuring that our high precision machining facility was an industry leader in Defense manufacturing. Worked on several large scale Department of Defense subcontracts.

Performed first article, in process and final inspections on all machined parts to comply with ISO standards.

Working knowledge of blueprint interpretation and application to make sure all parts were being machined to specifications outlined in the blueprints.

Routinely calibrated all of the company and employee owned measuring devices and kept accurate calibration records. This included micrometers, calipers, indicators, gauges and scales.

Collaborated with other departments to make sure purchase orders were being filled and shipped according to customer expectations with a zero return rate.

Developed and implemented SOPs and Corrective Action Plans to meet and maintain the company's quality goals and initiatives.