Doris Lafquen

Experience

• 

  Genesis Neuroscience Clinic

  Mar 2017 - Aug 2019

  Undergrad Intern-Clinical Research Coordinator

  • Experienced in double blind, placebo controlled, open label, assessor blinded, and comparator trials.• Primary Coordinator •Procedures performed include Medical History, ePROs, Collection and Reporting of AEs/AESI/SAEs/Conmeds, Vitals, ECGs, Pharmacy, and Photography.• Performing day-to-day execution of clinical research protocols: - Maintaining regulatory binders including correspondence, staff training, staff GCP, delegation logs, Protocol deviation logs, enrollment and screening logs, SAE logs, NTFs, and IRB approved subject materials. - Maintaining pharmacy binder and drug accountability for used, unused, and destroyed IP. - Timely data entry and answering of queries in eCRFs. • Ensuring quality of data and documentation of studies by performing routine quality checks of highest enrolling studies and studies likely to be FDA audited. • Documenting and conducting appropriate correspondence and notifications regarding severe adverse events. Show less

• 

  Tennessee Retina

  Aug 2019 - Mar 2021

  Ophthalmic Technician

  • Triaging patients (review of systems, med reconciliation, allergies, past medical/ocular, social history, family history), CVF, Motility, Pupil Evaluation, Amsler Grid, Color Plates, OCTs• Corneal Topography, Humphrey Visual Field (30-2, 10-2, and Bleph)• A Scan Set Up, Post op visit (Cataract, Yag, Bleph), IOP/ Diagnostic Drops• Distance and Near Visual Acuity (with/without correction & Pinhole), Brightness Acuity Test•Typing, Filling, faxing, ensuring telephone coverage, respond to customer inquiries, scheduling Show less

• 

  ADVANCED NEUROSCIENCES INSTITUTE

  Mar 2021 - May 2022

  Senior Clinical Research Manager

  • High enrolling site for Phase 1,2,3 and 4 clinical trials. Perform strict adherence to GCP/ICH guidelines during the administration of clinical trial products.• Experienced in double blind, placebo controlled, open label, assessor blinded, and comparator trials. • Primary Coordinator for 13 Studies.• Clinical Visits for all studies including registry studies. Procedures performed include Medical History, ePROs, Collection and Reporting of AEs/AESI/SAEs/Conmeds, Vitals, ECGs, Pharmacy, and Photography.Recruitment and enrollment of clinical trial subjects to include: blinding parameters, administer investigative product to subject, conduct subject appointments and scheduling, prepare and package for shipment of all lab testing under IATA guidelines• Performing day-to-day execution of clinical research protocols: - Maintaining regulatory binders including correspondence, staff training, staff GCP, delegation logs, Protocol deviation logs, enrollment and screening logs, SAE logs, NTFs, and IRB approved subject materials. - Maintaining pharmacy binder and drug accountability for used, unused, and destroyed IP. - Timely data entry and answering of queries in eCRFs. • Ensuring quality of data and documentation of studies by performing routine quality checks of highest enrolling studies and studies likely to be FDA audited. • Use excel to track protocol amendments, IB amendments, new ICFs, and patient facing materials ensuring all trainings, signature pages, logs, and IRB approvals are up to date, completed, and filed. • Coordinating with CRA for study guidance and troubleshooting. Assist with site initiation visits, interim monitoring visits, and close out visits.• Documenting and conducting appropriate correspondence and notifications regarding severe adverse events.• Coordinating of transfer patients to and from different sites.• Maintaining calibration binder ensuring up to date certificates for all onsite equipment.• Attend Investigator Meetings Show less

• 

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  May 2022 - now

  Site Manager

  -Acts as primary local company contact for assigned sites for specific trials.-Responsible for executing activities within site initiation and start-up, preparation and conduct of sitemonitoring (including remote monitoring), site management (by study specific systems and otherreports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.-Responsible for the implementation of analytical risk based monitoring model at the site level and towork with site to ensure timely resolution of issues found during monitoring visits.-Ensures site staff are trained and the corresponding training records are complete and accurate at anytime point during all trial phases. Responsible in close collaboration with LTM and central study teamfor the activities during site activation phase in order to speed up the process and activate the site inshortest possible timeframe.-Contributes to site level recruitment strategy and contingency planning and implementation inpartnership with other functional areas.-Ensures that clinical drug supplies are appropriately used, handled and stored and returns areaccurately inventoried and documented.-Ensures site staff complete data entry and resolve queries within expected timelines.-Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints(PQCs) are reported within the required reporting timelines and documented as appropriate. For-AEs/SAEs, ensures that they are consistent with all data collected and with the information in thesource documents.-Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-upletter in accordance with the SOPs. Promptly communicates relevant status information and issuesto appropriate stakeholders.-Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed forQuality Assurance (QA) site audits Show less