Sunnyvale, California, United States
Results-driven Clinical Research Associate and Clinical Trial Associate with extensive experience in managing Phase I, II, III, and IV clinical studies in biologics and medical devices. Proven track record of ensuring protocol compliance, data integrity, and patient safety while maintaining high standards of quality and efficiency. Skilled in coordinating with cross-functional teams, liaising with investigators and sponsors, and managing site relationships. Seeking to leverage expertise in clinical research to contribute to impactful projects and advance healthcare outcomes.
My dad had a stroke a few years ago and 2 heart attaks in the last 5 months. Prior to that I had two breakdowns handling life and work at the same time. I could not continue pretending I was inhuman so I took my right to get the rest I need. If you are unable to comprehend that, do not follow me or reach out. Thanks!
• Ensured understanding of clinical protocols and site specifications. • Monitored and tracked patients enrolled in clinical trials. • Maintained regular communication with counterparts at Contract Research Organizations (CROs) and trial sites. • Reviewed assigned clinical documents (e.g., protocols, Informed Consent Forms, manuals) to ensure clarity and accuracy, adhering to ICH/GCP guidelines. • Conducted site feasibility assessments and managed recruitment efforts. • Conducted site specific Informed Consent Form (ICF) review. • Evaluated and drafted study plans encompassing. • Reviewed Site Visit Reports for accuracy, quality and consistency. • Performed Quality Control (QC) review of Trial Master File (TMF). • Provided support in FDA inspections, reviewing and retrieving documents from TMF. • Participated in user acceptance testing (UAT) of clinical systems such as EDC and interactive response technology (IRT), and contribute to systems requirements authoring when necessary. • Ensured clear and timely distribution of meeting agendas, taking comprehensive minutes for both internal and external meetings. • Provided essential study-level information to facilitate accurate and efficient supply of clinical products to sites. • Assisted in study start-up activities with clinical sites and cross-functional team to facilitate green light of patient enrollment. • Accountable for ensuring that agendas for meetings were clear and distributed in advance; Took comprehensive and precise minutes for internal and external meetings. • Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking. • Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations. • Oversee clinical trial deliveries and shipment of study supplies • Follow precise departmental and company quality/administrative procedures
• Participated in review of CRF guidelines and developed understanding of ongoing clinical data review. • Prepared and reviewed of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc.) and responsible for the follow up to collect outstanding documents. • Managed and maintained information and documentation in eTMF and various other systems as appropriate and per timelines. • Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performed clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local activities in compliance Laws Regulations, Protocol, Site Monitoring Plan and associated documents. • Managed and maintained information and documentation in eTMF and various other systems as appropriate and per timelines. • Coordinated shipment of investigator product and trial supplies to study sites. • Maintained accurate and up-to-date clinical study documentation. • Monitored and tracked patients enrolled in clinical trials to ensure adherence to protocols and data collection timelines. • Reviewed and updated Standard Operating Procedures (SOPs). • Participated in providing study updates for annual IND reports.
• Worked with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Performed monitoring visits to clinical research sites and tracked patients enrolled in clinical trials to ensure adherence to protocols and data collection timelines. • Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluated the quality and the integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. • Escalated quality issues as appropriate. • Managed progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. Supported start-up phase. • Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regulatory visit reports, generating follow-up letters and other required study documentation. • Collaborated and liaised with study team members for project execution support as appropriate.