Amanda Brophy Email & Phone Number

Maryland, United States

Develop and manage studies for the entire business unit or large development program and lead study-specific study management and monitoring activities.Oversee study, investigator, health care provider and/or advisory board contract generation and sunshine reportingServe as study monitor over study conduct and milestone progress.Address issues that may arise during execution of clinical studies.Manage relationships with site personnel and other study related vendors, including CRO’s.Define, track and report schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables for assigned studies.Prepare, review and execute study-related or essential study start-up documents as they relate to the assigned BD post market clinical trials. (e.g. Clinical Protocols, Investigator Brochures, Monitoring Plan, Training Manual, list of supplies, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).Ensure study supplies and site/investigator payments are initiated and maintained.Interact with other Medical/Scientific Affairs stakeholders to build, maintain, and document evidence generation activities.Assist in designing, organizing, and updating evidence generation portal, websites, and/or Microsoft Teams sites for access by Medical/Scientific Affairs stakeholders.Track all study and publication activities in evidence generation portals, SharePoint and/or team sites.Coordinate with other Medical/Scientific Affairs stakeholders to facilitate evidence generation updates, relevant to product lines, to a wider BD audience.Collaborate within the business unit and across global Medical Affairs including global Clinical Affairs and medical governance.Generate, execute, and maintain contracts in support of major business unit objectives such as clinical trials, speaker/conference engagements, consulting services, and/or advisory boards.

Sparks Glencoe, Maryland, United States

Ensure that clinical site staff complete tasks in accordance with the project agreements, Protocol, BD procedures, and applicable regulations (ICH-GCP, HIPAA, CFR, ISO).Document and report non-compliance in a timely manner.Ensure that all clinical events are reported appropriately.Conduct investigational product accountability, subject screening/enrollment assessments, case report form monitoring/verification, and query resolution and ensure compliance with core lab requirements and submission of data for analysis.Conduct training of investigators and coordinators.Participate in site qualification and initiation activities, including training of investigators and coordinators.Develop and implement site corrective actions as needed to address any noncompliance issues Participate in site close out activities including but not limited to coordination of clinical specimens back to BD or off-site storage facility, meeting with site staff and PI to discuss close out process and required documents, complete close-out report, finalize all study related documented, and ensure eTMF is accurate and complete.

Baltimore, Maryland Area

In my role as Project/Study Coordinator, I work closely with the Study Monitor to make sure the site is in compliance with Good Clinical Practices as well as all National and Local Regulations. I maintain the Investigator Site File binder, fill out study specific documentation, work with data management staff to identify and resolve data and/or reporting issues and mentor other associates on how to successfully perform the duties of a research site staff member. I also manage a separate clinical trial where I review the Informed Consent Form with interested individuals and consent them if eligible, manage all subject data information, ensure that subject confidentiality is protected, confirm that all participation documentation is credible and accurate, and interact with the IRB when necessary.Lastly, I am involved with the verification and validation process for multiple diagnostic instruments. In this role, I write and execute protocols that validate the performance of these instruments. I also perform various characterization experiments that may be used as additional support for aforementioned validations.

Baltimore, Maryland Area

Manage the BD Clinical Trial site: o Logging and characterizing patient specimens as they were received o Keeping a current and accurate inventory log of all consumable materials usedand which instrument specific specimens were ran ono Making sure supplies were in stock at all times so as not to delay specimen testingo Promptly running specimens on both the MAX platform and the Viper XTR platformo Performing weekly lab cleanings and environmental monitoring to demonstrate a clean and target-free work environment o Uploading run results on a daily basis so that data analysis and statistics can be completedo Shipping remnant specimens to other testing sites for further testing on other reference methodso Analyzing data when results were discrepant or needed further investigationLead the BD Associate Sample Collection Program. o Training supporting staff members to help reconcile specimens collected against consented subjects o Sending out collection emails in advance in order to inform subjects of collection opportunities o Inputting newly consented subjects into the online database (Clindex)o Giving all newly consented subjects the proper forms and contact information in order to obtain a vendor ID so that they can be paid under the protocol o Inputting individual subject participation forms into Clindex o Submitting for subject payment through Clindex on a monthly basis o Fixing any errors in Clindex, the Informed Consent Forms (ICF) and reaching out subjects to fix any errors or incomplete participation formso Keeping an updated and accurate record of current subjects eligible to participation in the program Assist in the development and qualification of specimen processing workflows on automated systems.Assemble relevant information in support of regulatory submissions.Perform a massive assay comparison on all BD MAX instruments currently in the R&D fleet in order to determine variations in MAX performance.

Baltimore, Maryland Area

Generate and manage inventory of multiple drug resistant cell lines Determine the IC50 values of various drug resistant cell lines Perform in-vitro kinase assays to determine inhibitory effects of a novel small molecule inhibitor Utilize immunoprecipitation methods in order to isolate specific protein complexes from cell culturePerform differential scanning fluorimetry(DSF)/thermal shift assay and fluorescence anisotropy/polarization to asses binding affinity of compounds to various proteins Optimize protein purification assay in order to get the highest quality of isolated protein for subsequent experiments Perform dot blot and/or Western Blot analysis on cell lysates and in-vitro kinase samples in order to quantify signaling cascades and the effects of small molecules on these pathwaysMentor rotational students (high school, undergraduate and pharmacy) in various experiments that are performed in the labKeep lab supplies stocked and order materials as requested by lab members

Conducted bacterial transformation of DNA as well as DNA transfection of mammalian cells. Isolated DNA and verified plasmid expression. Determined gene expression through luciferase assay. Performed viability assay to determine cytotoxicity of small molecule compounds.Maintained cell cultures of various cell lines. Detected and analyzed protein expression through Western blot assays. Transformed DNA, induced protein expression and subsequently purified protein in order to conduct kinase assays.

York, Pennsylvania Area

Enter customer prescriptions into the CVS computer systemCorrect problems with insurance or doctor’s offices and notify the customer if necessaryFille customer prescriptions Assist with customer pick up of prescriptions Keep prescription waiting bins organized Order out of stock medicines Make calls to customers to inform them about the CVS automatic refill program

Washington D.C. Metro Area

Managed the breeding, weaning, and tailing of mice to better suit the research needs of the lab Ran PCR tests to verify gene expressions of mice Examined and interpreted histopathology and immunohistochemistry results from mice tissues Assisted with western blot analysisManaged the administration of a potential treatment to a line of mice with medulloblastomaContributed to data organization and compilation, database upkeep and notebook records

Master Of Science (M.S.), Pharmaceutical Sciences

Bachelor Of Science (Bs), Animal Sciences

Activities and Societies: Collegiate FFA, STAND (A Student Anti-Genocide Coalition), Billiards Club, Study Abroad: Tanzania, Worked.