Lauren Merante Email & Phone Number

Chapel Hill, Nc, Us

Durham, North Carolina, United States

• Executes multiple clinical studies and assumes responsibilities delegated by the project management team, including the preparation, distribution, filing and archiving of clinical documents and templates necessary for study activation.• Owns site startup activities, including site identification, creation of site recruitment questionnaires, collection, review, and approval of essential documents to support site qualification and activation.• Maintains the company's Clinical… Show more • Executes multiple clinical studies and assumes responsibilities delegated by the project management team, including the preparation, distribution, filing and archiving of clinical documents and templates necessary for study activation.• Owns site startup activities, including site identification, creation of site recruitment questionnaires, collection, review, and approval of essential documents to support site qualification and activation.• Maintains the company's Clinical Trial Management System (CTMS) and Project Study File (PSF) in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).• Manages all maintenance and close out activities throughout the life cycle of the study.• Interacts with sites, vendors and clients through written/verbal communication and manages study-related action items and issues.• Facilitates internal and external meetings, tracks attendance, prepares all agendas, documents meeting minutes and outstanding action items for all attendees.• Manages the Trial Master File (TMF) filing for each assigned study.• Oversees the study progress by tracking study milestones in the Clinical Trial Management System (CTMS).• Routinely stays abreast of GCP and updated guidance from FDA as it relates to clinical research.• Performs Remote Data Review (RDR) in compliance with applicable SOPs and work instructions.• Prepares, handles and distributes Site Reference Manual, Investigator Site Binders, Pharmacy Manual and any other relevant study-specific manuals.• Leads the identification and recruitment activities of investigative sites using available technologies and existing databases.• Submits timely and accurate project status reports as required by the Project Manager, Sponsor or project team.• Thoroughly understand study protocol(s), plans, and associated timelines/deliverables. Show less

Durham, North Carolina, United States

PharPoint is a client-focused Contract Research Organization (CRO) based in the United States that provides Phase 1 through Phase 4 clinical trial support. For the past 15+ years, we've supported innovative pharmaceutical, biotechnology, and medical device companies of all sizes. As an intern at PharPoint, I assisted with the following:• Organized and maintained the Project Study File (PSF) and performed other project administrative functions for clinical trials in accordance with GCP… Show more PharPoint is a client-focused Contract Research Organization (CRO) based in the United States that provides Phase 1 through Phase 4 clinical trial support. For the past 15+ years, we've supported innovative pharmaceutical, biotechnology, and medical device companies of all sizes. As an intern at PharPoint, I assisted with the following:• Organized and maintained the Project Study File (PSF) and performed other project administrative functions for clinical trials in accordance with GCP and Standard Operating Procedures (SOPs).• Assisted members of Clinical Operations and other departments as needed in order to gain exposure to the daily responsibilities within a research setting.• Communicated accurate and timely status updates to other project team members and department management. Show less

Chapel Hill, North Carolina, United States

As a Clinical Operations Admin Assistant at the UNC Adams School of Dentistry, I supported the delivery of high-quality dental care to patients by issuing instrument orders, tracking product usage, maintaining medical equipment inventory, and digitizing 3D patient models. I completed annual HIPAA training with a 100% score, ensuring full compliance with data privacy and security standards.

North Carolina, United States

• Enhanced digital accessibility by creating captions and transcripts for 83 videos in the University Library archives using Microsoft Stream

Wilmington, North Carolina, United States

• Delivered exceptional customer service by promptly resolving issues and addressing inquiries, ensuring customer satisfaction both in person and over the phone• Processed customers’ purchases using Point of Sale systems• Trained and mentored new staff members