Abbey Bailey Email & Phone Number

Cambridge, Ma, Us

Boston, Ma, Us

Worked at the Neurological Clinical Research Institute (NCRI). The NCRI is a premier Academic CRO housed at MGH.• Provided project, vendor, and trial site management for the first-ever platform trial for ALS: the HEALEY ALS Platform Trial (a combined total of 75+ trial sites across the USA).• Planned, led, and facilitated cross-functional project meetings to ensure study targets and timelines were met, identify risks, address issues, & respond strategically• Built the Vendor Project Management team from the ground up to manage 20+ vendors and support 7+ study drug regimens. Grew position from a single individual to a specifically dedicated 6-person team.• Developed onboarding plan for and directly oversaw the work assistant project managers• Point of contact for vendors & liaison with internal team members, sites, & Sponsor.• Developed manuals, instructions, & workflow process documents for vendor management & internal teams.• Established a method of sample oversight & reconciliation to manage an inventory of 96,000+ biomarker samples and shipment to 11+ specialty analysis labs• Worked closely with Grants Management on study budget related questions & development of vendor SOWs• Led vendor RFP, evaluation, & selections• Established process for review of SAEs involving Data Management, Clinical Monitoring, Pharmacovigilance, & Project Management Teams to ensure completeness of data collection prior to drug regimen closeout.• Developed trackers for site start-up & management tracking, vendor management, data transfer status through to drug regimen close-out, document management, & site study supply management.• Oversaw collection, reviewed, & approved required regulatory documents from 18 sites across the USA in accordance with ICH GCP and FDA CFR regulations. Ensured eTMF was audit ready.• Reviewed monitoring visit reports & protocol deviations to support the identification of trends across sites. Worked with sites to resolve quality issues.

Boston, Ma, Us

Worked at the Neurological Clinical Research Institute (NCRI). The NCRI is a premier Academic CRO housed at MGH.Assisted overall project management of the first-ever platform trial for ALS: the HEALEY ALS Platform Trial.• Helped manage the scope, schedule/timelines, budget, quality, and resources of the trial, delivering projects from initiation, to implementation, to close-out• Assisted in development, system testing, and roll out of the invoicing system. Developed workflow, instruction manual, and training video for quarterly processing of site invoices. Trained project managers, assistant project managers, and grants managers.• Developed study materials including protocol and informed consent forms, study manuals, manual of procedures, source documentation templates, recruitment materials, and other study tools• Created trackers for project management and cross-functional teams. Assisted in tabulating key metrics for overall study tracking, progress reports, meetings, and presentations• Collected, reviewed, and approved required regulatory and training documents from 25 sites across the USA. Ensured eTMF audit-readiness.• Developed agendas and drafted meeting minutes for meetings with sites, vendors, and cross-functional teams. Led meetings as needed.

Boston, Ma, Us

Worked under Doctors Braden Kuo and Kyle Staller, facilitating the research activities of 15+ Phase II – III investigator-initiated and industry-sponsored research studies focused on Disorders of Gut-Brain Interaction.• Conducted all studies in accordance with FDA, ICH, GCP, sponsor procedures, and hospital standards• Served as liaison between industry sponsors, CROs, investigators, central IRB, local IRB, MGB Legal & Financial departments, Clinical Trials Pharmacy, and subject populations• Responsible for study start-up procedures and documentation, CT.gov reporting of investigator-initiated trials, study maintenance, study closeout, assisting with study analysis and liaising with study biostatistician, contributing to the review and editing of manuscripts for publication• Created, maintained, and verified accuracy of investigator site file, regulatory documentation, IRB submissions, SOPs, manuals, data management logs, and source documentation work sheets• Developed investigator-initiated detailed protocols, ICFs, and budgets• Trained and helped supervise new employees and research fellows. Mentored and developed inexperienced research coordinators to meet the demands of recruitment, follow-up, data collection, medical record analysis, literature reviews, and all trial needs.

Boston, Ma, Us

Provided clinical research and administrative support to Dr. Lee M. Kaplan and members of the Obesity, Metabolism & Nutrition Institute (OMNI) of MGH.• Recruited & consented subjects at the MGH Weight Center, performed data entry, maintained regulatory documents, scheduled subject visits, processed blood samples, attended gastric bypass surgeries to collect and divide subject tissue samples, coordinated sample collection and surgery attendance with a collaborating lab

Boston, Ma, Us

Aided instructors in teaching small adult classes focused on topics pertaining to recovery and rehabilitation from psychiatric illnesses.

Chestnut Hill, Ma, Us

Completed a Senior Honors Thesis under advisement of Professor Gene Heyman, Ph.D. of the Boston College Psychology Dept.

Chestnut Hill, Ma, Us

Chestnut Hill, Ma, Us