BS, Biotechnology @
California State Polytechnic University-Pomona
I began in the pharmaceutical field as a Clinical Research Coordinator for a highly regarded Neurologist in San Francisco for 2.5years. I have conducted studies for patients with Alzheimer's, Parkinson's, Neuropathy and Migraines. I am best known for genuine consideration of my patients and ability to autonomously manage a large workload. I am a motivated, emotionally intelligent
I began in the pharmaceutical field as a Clinical Research Coordinator for a highly regarded Neurologist in San Francisco for 2.5years. I have conducted studies for patients with Alzheimer's, Parkinson's, Neuropathy and Migraines. I am best known for genuine consideration of my patients and ability to autonomously manage a large workload. I am a motivated, emotionally intelligent and amiable professional best characterized by the thorough actions and decisions I make in the workplace to create an environment of trust, learning and levity that is my signature. I am a situationally aware individual who knows how to prioritize, and re-prioritize, by carefully evaluating as many factors as possible. I work well with others and enjoy sharing achievement in common goals. I show empathy to my coworkers and peers when they need it and I have been known to help them through times of stress. I am quick to learn and am able to apply old lessons to new problems. I am resourceful, mindful and caring. I take pride in my work.
Clinical Trial Associate @ Provides logistical support for one or more early development (i.e. phase I & II) Oncology and ITGR clinical studies.
Duties: Provide logistical support for Study Team
• Develop, maintain and manage appropriate study documentation
• Collect, review and approve regulatory documents from clinical sites
• Initiate, maintain and reconcile Trial Master File
• Set up and maintain tracking systems and tools and report study metrics to support the clinical study
• Coordinate communication of tracking information within Study Team and to sites
• Manage and track clinical and non-clinical supplies
• Manage and track study-specific payments
• Develop study related documents in collaboration with the study team. From April 2014 to Present (1 year 9 months) Clinical Project Assistant @ Assist in the management of Phase I, II and III oncology clinical trials to support the project team including oversight of CROs, Biosample tracking, TMF reconciliation and CSR report generation.
• Assist in the management of multiple oncology clinical trials in phases I and II.
• Working experience with InForm eDC systems, BioClinica CTMF, Medpace Web Portal, ACM Global Laboratory Portal and Excel spreadsheets to identify, maintain and reconcile site files and subject data.
• Assist in the resolution of QA department’s audit observations within the TMF for audit preparedness.
• Manage CRO personnel for study site guidance of laboratory bio-sample shipping and reconciliation.
• Review Monitoring Trip reports via Web Portal of the study’s CRO vendor to ensure sponsor directives are met.
• Compile appendices and provide quality checks for Tables, Listings and Figures for final CSR submission.
• Update currently active sites on Clinicaltrials.gov to enhance study protocol subject recruitment.
• Create and maintain accurate records for project trackers and chronicling meeting minutes. From July 2013 to March 2014 (9 months) Clinical Trial Assistant @ • Responsible for management of study specific Trial Master Files for the clinical project; specifically CIF & CCF regulatory document organization, distribution, retrieval, verification and tracking.
• Accountable for accurate updates and maintenance of clinical systems such as Inntrax, InFORMant and CTMS, within project timelines during fevered close-out deadlines.
• Vital to timely and effective communication with site personnel, IRB personnel, records personnel, CRAs, CTLs, and LMs to facilitate the preparation, handling, distribution, filing and archival of clinical documentation.
• Create and maintain accurate records for the project team including regulatory documents, trackers and chronicling meeting minutes.
• Synchronize with monitors and site coordinators by carefully identifying outstanding documents for efficient close-out of study sites.
• Essential in conducting the QC and “All-Tasks Complete” processes for shipment to sponsor at project Close-Out.
• Active trainee in Quintiles SOPs and Genentech/Roche SOPs through virtual and in-person training sessions. Also took initiative to seek the advice of mentors and peers to enhance CLINOPS department understanding.
• Proudly passed Barnett GCP test in first attempt. Cert. of Completion required by Quintiles in three attempts.
• Willingly volunteered to be a first responder in office crises, called an “Emergency Monitor” requiring certification in first aid response: CPR, Heimlich maneuver and AED training.
• Thoughtfully chosen, by manager, to represent the CLINOPS department in an interdepartmental meeting to discuss tuning and the working challenges of CTAs. From October 2012 to March 2013 (6 months) Greater San Diego AreaClinical Research Coordinator @ • Employed to accomplish the tasks of sponsor constructed clinical trial protocols with Good Clinical Practice while adhering to IRB, FDA and NIH guidelines for the protection of human subjects.
• Responsible for the accurate completion of all study start-up and close-out regulatory documents including the FDA 1572 form, Financial Disclosure Forms, CVs, medical and DEA licensures, Protocol and Investigator Brochure signature pages and IRB site submission documents.
• Efficient and thorough in regulatory document processing; as required for the start-up and close-out in over ten unique clinical trials.
• Delegated to direct, maintain and coordinate clinical research trials.
• Research management responsibilities include recruitment of subjects, informed consent discussion and documentation, review of medical history, collection of subject vital signs and electrocardiograms, psychological rating and assessments, subject dosing, scheduling and equipment training, electronic and paper CRF data entry, query resolution, laboratory specimen collection and shipping, drug accountability, dispensation and temperature monitoring, deviation reporting, adverse event monitoring and reporting, management of ISF study documents, tracking of study supplies and patient reported outcomes via IXRS, timely correspondence with CROs, CRAs, medical monitors and project managers.
• Active participant in training events including internet hosted teleconferences and investigator meetings.
• Adept in hosting all study personnel and CRAs during site initiation, interim monitor visits and site closeout visits with preparedness, diligence and professionalism.
• Provided training and assistance as Senior Coordinator for five other employees, ensuring GCP guidelines and standard operating procedures of the site are made top priority. From April 2009 to November 2011 (2 years 8 months)
B.S., Biotechnology @ California State Polytechnic University-Pomona From 2004 to 2009 Timothy Toy is skilled in: GCP, Clinical Trials, Oncology, CRO, Clinical Development, EDC, CTMS, Biotechnology, FDA, Pharmaceutical Industry, Clinical Research, ICH-GCP, SOP, Protocol
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