Conduct and oversee enrollment to ensure that informed consent is properly obtain/documentedMonitor study activities to ensure compliance with protocols and with all relevant local, federal and state regulatory and institutional policiesConduct screening and review of medical records with PI for potential eligible subjectsApply FDA regulations and ICH-GCP guidelines to all aspects of clinical studies including with protocol compliance, informed consent review, source documentation review, IRB submission, assist with regulatory submission and start-upUpdate and maintain project related systems, database, tracking tools, timelines, and project plansInteract with CRA/Sponsors to obtain study documents, related information and monitoring visitMaintain study documents in electronic trial master file and participate in periodic review of Trial Master FileCoordinate the reporting of AE and SAE’sTrain new CRC, and interns using ICH-GCP guidelinesPerform collection of Lab specimens and shipment

Under guidance, prepares, reviews and coordinates local regulatory submissions in alignment with the global submission strategy. Coordinates with internal functional departments, to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines. Ensures the submission process for sites and studies are aligned to the critical path for site activation. Has contact with investigators for submission related activities and serves as a key contact at country level for either Ethical or Regulatory submission related activities. Achieves PPD target cycle times for site. Prepares Regulatory Compliance Review packages, including working with the SIA CRA as applicable. Develops country and site-specific Patient Information Sheet/Informed Consent form documents

Oversaw subject enrollment to ensure that informed consent was properly obtained/documentedConduct and oversaw screening and review of medical records with PI for potential eligible subjectsCorrespondence, protocol, informed consent form, IB, IRB, laboratory and  monitoringPrepared for quality assurance audits conducted by study sponsorsUpdate and maintain project related systems, databases, tracking tools, timelines and project plansMaintained the tracking of Essential documents, CRF’s, ICF’s and 1572’sPerform all subjects Schedule of Events onsiteReporting of AE’ and SAE’s

Shift leader for over 7 employees in my package and shipping departmentOversaw and maintained the machinery for operational status at all timesTrained employees on equipment and the current packaging procedures for the product of the dayOversaw safety work environmentConduct tracking of all production made for my shift in the database, Relieved and position employees for task and breaks

Supervised Production for employees by creating schedules Ensure operators are completing operator checklistEnsures product produced meets quality standards by conduction QC testing, documenting results and correcting process or material issues when defects are identified according to the QC StandardsAssists with the training of operators or packers if necessaryFollows procedures for daily and weekly machine inspection, preventive maintenance, and cleaning and brings to the attention of supervision any items that may need to be fixed or looked at