Operations Associate Lab Assistant

AMBER D. BROWN

Professional Summary

Highly organized professional with 8 years of experience with Clinical Studies. Proven success in clinical project management including timelines, milestones, risks, and budgets in the areas of central lab vendor/CRO services, clinical site coordination, and clinical supply. Proficiency with multi-tasking, logistical coordination, and problem-solving as well as sponsor, CRO, and vendor management.

Skills

ICH/GCP Guidelines

Clinical Supply

Project Management

Specimen collections

Study protocols

Good Clinical Practices

Process Improvement

Clinical Research

Proficient in EDC and CTMS systems

Inventory Management

Project organization

Professional Experience

Natera, Clinical Trial Operations Associate (contract) May 2021-Present

Effectively manage the clinical trial kit specification, order, and supply process for several global clinical studies

Lead client calls internally and externally

Partner with external stakeholders to ensure client deliverables are met for all sites globally.

Work cross functionally to execute clinical plans and materials

Track collection kits throughout their fulfilment cycle

Manage production timelines, kit inventory, and study material forecast

Investigate and resolve clinical trial issues internally and externally

Streamline and optimize kit production processes so that lead times, redundancy, and margin for error are minimized

Manage clinical trial documents, generate weekly clinical trial reports

Train and provide guidance to international investigational site staff on required import/shipment approval processes

Provide logistical support for importing and exporting clinical materials

Collaborate with internal stakeholders to implement NCR CCR

Ensure compliance with regulatory requirements, creating quality assurance SOPs as necessary Covance Central Laboratory, Project Management / Study Coordinator July 2016-May 2021

Clinical study central lab project management for Phase I-IV clinical trials

Responsible for day-to day oversight, management, planning, and coordination for all clinical study projects, ensuring compliance with protocols

Managed local and global vendors, including several CROs

Maintained constant communication with Sponsors, CRAs, and investigators to ensure all studies are functioning properly

Collaborated to prepare for study kick off meetings and to complete the study design

Assisted the global manager with sponsor budget negotiations for a variety of studies

Provided training at investigational meetings for investigators, CRAs and study coordinators

Demonstrated ability to successfully handle challenging clients in a faced-paced environment

Ensured compliance with regulatory requirements by maintaining documentation

Performed data reconciliation throughout each project

Gathered, processed, and shipped lab collection kits and lab specimens

Participated in study audits

Mentored and trained new hires

Actively participated in department and company initiatives for process improvement Indiana University, Lab Specialist August 2017-March 2018

Prepared and analyzed client samples for sponsor clinical study participants and IU hospital patients

Receiving and processing of returned specimen and kits from clinical sponsors.

Fielded client and customer inquiries regarding specimen testing.

Processed specimens (serum, plasma, ligaments, tissue) for testing and prepared samples for shipment to referral laboratory

Recorded data and track samples

Trained junior lab staff members in procedures such as kit opening and aliquoting Regenstrief Institute, Clinical Study Research Associate September 2015-July 2016

Facilitated Clinical research projects in collaboration with principal investigators

Coordinated patient enrollment in specific studies through telephones calls, emails, letters, and hospital visits

Assisted with submitting IRB submissions through RedCap database

Conducted investigator training for new studies, patient recruitment strategies, site operations and data collection techniques.

Managed data collection and prepared recruitment reports

Assisted with creating SOPs

Covance Central Laboratory Service, Senior Lab Assistant July 2014-September 2015

Liaise between Clinical Project Managers and laboratory technicians

Receive and process specimen and kits from clinical sponsors.

Conduct inventory counts on all clinical trial reagents, order lab supplies

Trained others in new processes and procedures such as kit opening and aliquoting

Resolve discrepancies between specimen, requisitions and Zavacor systems

Utilize various database and spreadsheet applications to prevent waste Freedom Pharmacy, Pharmacy Technician January 2011-June 2014

Retrieved and interpreted medication orders, updated patient charts, and generated and reviewed prescription labels for accuracy using FrameWork and other databases

Prepared IVIs using aseptic technique and compounding nonsterile medications

Trained new employees and students

Education

B.S. Chemistry and Biology, Martin University 2013

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