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.
• 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.
• 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.

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

• 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

• 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

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

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