Lauren Macdonald Email & Phone Number

• Review clinical study-related documents, including study protocols, protocol amendments, study manuals, Informed Consent Forms, Case Report Forms, Investigator's Brochures, Clinical Study Reports, regulatory submissions, and other documents as required.• Helps to ensure that the study is conducted in accordance with agreed upon timelines.• Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study. Ensures essential clinical documents are in place for approved/assigned sites to ensure timely site initiation and patient enrollment.• Contributes to the planning and coordination of investigator meetings, such as developing and presenting assigned sections of the meeting agenda/content.• Maintains relationships with assigned investigator sites and vendors.• Ensures investigator and investigator site personnel comply with protocols; recommends corrective action(s) as required.• Maintains accurate and updated study files.• Recommends strategies for the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.• Assists in configuration and implementation of study-related systems as appropriate (i.e., data management, study drug tracking, etc.).

Boston, Massachusetts, United States

• Customize/update any study-specific plans and process flows for multiple clinical vendors (i.e., TMF, site training, site monitoring, etc.)• Performs QC review of all documents submitted into the TMF and liaise with project teams to resolve any issues identified• Responsible for developing and updating the global study specific ICF templates package• Review essential documents packages prepared by the CRO for completeness and accuracy to ensure timely site activations• Assist with tracking compliance to all study-level plans and escalating any variances• Central point of contact for study-specific vendors• Participate in operation meetings with CRO, and cross-functional team members; document escalations and actions• Subject Matter Expert Lead for multiple initiatives to ensure consistent implementation of best practices across all studies—- Informed Consent Forms: Driver of the Informed Consent process. Responsible for updating and maintaining all ICF templates. Lead Team meetings with Legal and Data Privacy representatives, as well as other Key Stakeholders to review SOPs, Work Instructions, and Trainings. I have successfully implemented an ICF Tracker for all-study use and rolled out a company-wide training session.- Smartsheet: Developed a Trial Level Start-Up Dashboard for study teams comprised of high-level study information that provides key stakeholders a common understanding of key elements of the trial. Benefits include central location for general study information, organization of study documents (version control), and reference point for study team members. This Dashboard is now a requirement on all studies in start-up. - Other Initiatives: Participated in a TMF Index Revision Initiative with TMF Ops Group to (1) Clearly define document ownership for Alexion artifacts (2) Clarify alternate locations for TMF documents (3) Refining the CRO model partnership TMF Index templates.[Clinical Trial Manager II: October 2019 – June 2021]

Regulatory Coordinator I: March 2017 – November 2018• Track & manage assigned new protocol start-up packet; initiate, facilitate & monitor study start-up progress to ensure established benchmarks are met• Communicate & collaborate with key clinical trial personnel through the start-up process, provide regular updates & ensure all start-up activities are completed• Create & maintain tracking for all subsequent submissions to the SRC/IRB; specifically, protocol & ICF amendments for new/continuing studies • Prepare, track, & maintain all correspondence/regulatory documentation required by the IRB/other institutional oversight committees• Serve as facilitator for study team/sponsor regarding study status information, critical safety issues, upcoming protocol, consent/IDB amendments, & applicable protocol training• Communicate with Investigators/study teams with the status of regulatory approvals• Maintain/organize physical study regulatory binders, as well as the electronic regulatory files, for each assigned study & ensure each is in compliance with study sponsor/local institutional requirements• Assist in the preparation/coordination of assigned study monitoring and auditing visits• Serve as primary liaison to regulatory bodies and other oversight committees • Maintain knowledge/understanding of all active clinical trials to ensure regulatory compliance• Assist study team with regulatory-based training & implementation of new or revised regulation, guidance and local policy• Strong knowledge of regulatory requirements; working knowledge of FDA regulations, INDs, IDEs, and GCP/HSP training• Present regulatory status to disease group leaders at weekly meetings • Maintain training for onboard staff for 100+ clinical trials • Established the working relationship between the GYN Regulatory team and the GYN Minimal-Risk Tissue Banking team, and serve as their regulatory leader and primary contact for questions

• Screened subjects for eligibility using protocol specific inclusion and exclusion criteria• Conducted or participated in the informed consent process including discussions with research participants and answered any questions related to the study• Interacted with study participants as directed/required by the protocol • Attended procedures (i.e. surgery, paracentesis/thoracentesis, biopsy, etc.) to collect patient samples• Monitored patient appointments for future blood draws and upcoming clinic visits• Tissue sample work; requested specimens from outside institutions, as well as maintained internal specimens fresh from surgery• Collaborated with different laboratories and institutes to collect and ship samples • Worked with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management• Oversight of the clinical trials start-up process from receipt of protocols through the SRC and IRB submissions• Assisted PI and other members of the research team with drafting and editing the protocol, as well as the informed consent• Completed the following on time and when necessary: amendments, deviations/violations, and continuing reviews• Maintained and organized study regulatory binders and entered all required study data on an ongoing basis• Understood DF/HCC SOPs and the roles and responsibilities of other key departments within clinical research (ex. OHRS, ODQ, Clinical Trials Office (CTO), etc.)

Lake Buena Vista, Florida

• Analyzed salt and fresh water aquatic animal systems and marine holding areas• Fielded sample reptile, terrestrial mammal, and aquatic habitats weekly• Organized and took care of upkeep of the instrumental and water chemistry laboratories at Disney’s Animal Kingdom Theme Park and The Seas with Nemo & Friends Pavilion at Epcot• Operated analytical equipment, including: dissolved oxygen sensors, pH sensors, ORP sensors, tensionometers, turbidity meters, ion chromatography (Chromeleon), total organic carbon analyzer and spectrophotometer • Performed weekly bacterial testing of water – m-Endo, m-ColiBlue 24, and m-HPC broth• Held chemistry-related demonstrations in front of park audience

Assumption College - Worcester, Ma

• Provided technical services for students and faculty; sign out equipment • Assisted and troubleshooted problems for students • Assistant in multi-media and video production

Revere, Ma

• Administered general office duties• Day-to-day financial transactions; managed petty cash• Communicated with customers, employees, and other individuals to answer questions or explain information• Completed and mailed bills, contracts, policies, invoices, or checks • Inventoried and ordered materials, supplies, and services • Typed, formatted, proofread and edited correspondence and other documents• Managed 200 summer employees, scheduling, and payroll • Planned, organized, and booked field trips and entertainment for participating families in the city• Co-managed state grants, file paperwork, and data entry

Bachelor Of Arts (B.A.), Chemistry

Activities and Societies: Student Government

Education record

Activities and Societies: National Honor Society, Sociedad Honoraria Hispánica, Varsity Cheerleading, Power of Know