Amanda Moore, Mshs Email & Phone Number

Cleveland, Oh, Us

Cleveland, Oh, Us

Cleveland, Oh, Us

Waltham, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Leading multi-functional teams in the creation and maintenance of clinical development plans while also providing study management for rare disease global clinical trials.

Cambridge, Ma, Us

I led multi-functional teams managing global clinical trials while providing input to the program clinical development plans.

I led multifunctional teams managing global clinical trials while developing and maintaining clinical development plans.

Saint-Herblain, Pays De La Loire, Fr

I successfully managed global clinical trials within multifunctional teams for the development of new vaccines and led program development of a novel vaccine delivery system.

I managed vaccine development clinical trials and worked with and supervised members of the CRA/Trial Specialist staff.

Rockville, Md, Us

Supervise daily operations of the protocol monitoring team, both in-house and contract CRAs.Manage project budgets and government contracts. - Budget projections and expense reports- Sub-contracts and invoices- Contract re-competes- Sponsor contract office approvalsAssess and maintain appropriate staffing for all protocols.Complete reports to the sponsor.- Protocol timelines- Monitoring schedules- Monthly reports- Trial progress reportsLed study development from concept through implementation.Perform annual and periodic staff performance evaluations.Supervise orientation process for new staff.Led site visits while training new CRAs.Conduct training for national audiences via web seminars, teleconference and in-person meetings.

Rockville, Md, Us

Conducted initiation, interim, for-cause, and closeout site visits.Monitored compliance with ICH/GCP Guidelines and protocol procedures.Assessed proper reporting of safety data including adverse events.Reviewed source documents, CRFs, eCRFs, informed consent forms, and drug accountability records.Created templates for conducting site initiation and closeout visits.Revised and authored monitoring plans for the project and individual protocols.Protocol Development and ImplementationFacilitated national team conference calls and meetings. Contributed valuable operational level, regulatory, and safety information.Supported research sites throughout the implementation process. Regulatory Document MaintenanceMaintained regulatory files for multiple protocols. Tracked expiration dates and non-compliance with CFR regulations and GCP guidelines.Addressed any regulatory issues with the study sites.Trained national audiences on study procedures and assessments at investigator’s meetings.Developed and conduct training for a national audience via web seminars.Trained colleagues on site monitoring through hands-on experience and constructive guidance.

Traveled to regional substance abuse treatment centers to conduct baseline and follow-up visits with study participants.Followed protocol specific guidelines for a national study investigating behavioral interventions to reduce behaviors that increase the risk of HIV and Hepatitis C in the injection drug-using population.Administered standardized interviews and assessments to study participants and completed data entry. Maintained the spreadsheet used to track participants visits and completion dates. Designed and maintained a spreadsheet for internal quality assurance.

Kalamazoo, Mi, Us

Supervised and supported crisis workers and volunteers.Successfully completed crisis intervention training and provided training to new volunteers.Answered calls and met with clients for crisis intervention/management and referral.

Machine Learning: Implementation In Business, Certificate Program

Mshs, Clinical Research Administration

Bachelors Of Science, Psychology