Jacob Anthony Email & Phone Number

Rehoboth Beach, Delaware, United States

United States

Murray Hill, Nj

Serves as a liaison between study site and the project team. Ensures protection of subjects and subjects' rights through monitoring of adherence to Good Clinical Practices, FDA, ICH, IRB regulations, Standard Operating Procedures and protocol compliance. Monitors investigational drug studies in Phases I, II, III, IIIB, and IV, including: Source document review and comparison to CRF data, CRF review/retrieval and data corrections, Drug accountability, Maintenance of on-site investigator files, IRB documentation, Local laboratory documentation, Maintenance of investigational supplies, Reviews consent process for each subject (Informed Consent Form and source documentation), Verify patient eligibility, Assess protocol compliance and deviations. Handling of safety and efficacy issues, including, but not limited to: Serious adverse event reports, Adverse event trends, Treatment failures. Conducts site visits/contacts, including: Pre-study visits, Initiation visits, Routine visits, Study completion visits, NCI sponsored visits. Site visit report preparation within study specific timeframe and responsible for all aspects of site management as described in the study plans.

Responsible for interaction with clients/associates required on daily basis; Responsible for assay transfers and qualifications per ICH guidelines; Responsible for the scientific conduct of the project and communication of regulatory issues with more senior level team members; Cooperation with coworkers within an organized team environment or work alone with supervision; Manage time effectively to complete assignments in expected time frame; Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP.

• Provided bioanalytical support in a team environment to clinical development projects within Sanofi Research, primarily in the areas of LC and LC-MS/MS analysis of biological samples• Expected to carry out routine analysis in a high throughput environment, develop novel assays with supervision and maintain quality data• Performed routine bioanalytical procedures in the area of LC-MS/MS including applying basic troubleshooting techniques• Followed established departmental procedures (SOP’s, Protocols, Safety Procedures)• Learned routine analysis and computer systems applicable to duties and responsibilities• Accurately recorded methods and results in study documentation• Familiarized with the scientific basis of techniques being used for bioanalysis• Interpreted data to a limited extent, presented data in written form, and described methods orally• Worked with supervisor to draft method descriptions for study reports

• Responsible for mapping, monitoring, and evaluating the process and completion of pharmaceutical solid dosage forms• Analyzed processes and process variables using 6 Sigma methodology• Conducted parameter tests on finished products• Developed and accomplished validation protocols• Produced summarized reports of data collected during validation study• Constructed and maintained data analysis spreadsheets of processes for production• Interacted with cross-functional teams in ensuring timely execution of plant projects• Coordinated validation activities with respective departments to assure appropriate schedule completion• Presented protocol deviations, modifications, and findings to validation specialists• Retrieved, investigated, and reviewed partner groups' production data

Master Of Science (M.S.), Biology, General

Bachelor Of Science (B.S.), Chemistry