Experienced global clinical research management professional with over 10 years of experience working in multiple settings including a clinical research site, a CRO and with sponsor companies. Therapeutic areas and focus include vaccine development, immunology, substance abuse and mental health, infectious disease, behavioral and neurological disorders, small and large molecule development, process and team development, and US
Experienced global clinical research management professional with over 10 years of experience working in multiple settings including a clinical research site, a CRO and with sponsor companies. Therapeutic areas and focus include vaccine development, immunology, substance abuse and mental health, infectious disease, behavioral and neurological disorders, small and large molecule development, process and team development, and US Department of Health and Human Services (including contracts and trials for NIH).
Associate Director @ From May 2015 to Present (6 months) Cambridge, MASenior Clinical Operations Lead @ From August 2013 to April 2015 (1 year 9 months) Cambridge, MAClinical Development Manager @ I led multifunctional teams managing global clinical trials while developing and maintaining clinical development plans. From September 2012 to July 2013 (11 months) Clinical Operations Manager @ 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. From February 2011 to July 2012 (1 year 6 months) Vienna, AustriaClinical Trial Manager @ I managed vaccine development clinical trials and worked with and supervised members of the CRA/Trial Specialist staff. From March 2010 to February 2011 (1 year) Gaithersburg, MDProject Manager @ 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 approvals
Assess and maintain appropriate staffing for all protocols.
Complete reports to the sponsor.
- Protocol timelines
- Monitoring schedules
- Monthly reports
- Trial progress reports
Led 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. From November 2008 to March 2010 (1 year 5 months) Rockville, MDProtocol Specialist/Protocol Monitor @ 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 Implementation
Facilitated national team conference calls and meetings.
Contributed valuable operational level, regulatory, and safety information.
Supported research sites throughout the implementation process.
Regulatory Document Maintenance
Maintained 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. From August 2006 to November 2008 (2 years 4 months) Research Assistant @ 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. From January 2005 to October 2006 (1 year 10 months) Shift Team Leader/Crisis Worker @ 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. From January 2004 to July 2006 (2 years 7 months)
MSHS, Clinical Research Administration @ The George Washington University School of Medicine and Health Sciences From 2008 to 2011 Bachelors of Science, Psychology @ Western Michigan University Amanda MSHS is skilled in: CRO, GCP, ICH-GCP, Clinical Trials, FDA, Clinical Research, Infectious Diseases, Vaccines, Protocol, Clinical Operations, CTMS, Therapeutic Areas, Clinical Development, Biotechnology, EDC, Regulatory Submissions
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