Experience

Volastra Therapeutics

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Clinical Project Manager

  • May 2023 - Present



Replimune

• United States
• Biotechnology Research
• 100 - 200 Employee

• Senior Clinical Project Manager

  • Apr 2023 - May 2023

• Clinical Project Manager

  • Dec 2021 - Apr 2023



Sumitomo Pharma Oncology

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Project Manager

  • Apr 2021 - Dec 2021

• Senior Clinical Research Associate

  • Apr 2019 - Apr 2021

• Clinical Research Associate

  • Sep 2016 - Apr 2019

  • Participation in the evaluation of clinical trial site locations. • Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out. • Traveling to sites as necessary to conduct site qualification, initiation, and close-out (<10%). • Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements. • Working with clinical site staff and… Show more • Participation in the evaluation of clinical trial site locations. • Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out. • Traveling to sites as necessary to conduct site qualification, initiation, and close-out (<10%). • Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements. • Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety. • Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements. • Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials. • Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies. • Helping to draft study manuals and protocol amendments as needed. • Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials. • Coordinating the movement of laboratory samples between clinical sites and central laboratories, and tracking the status of samples and resulting laboratory data.



Massachusetts General Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Coordinator

  • Dec 2014 - Aug 2016

  • Plan, design, coordinate and conduct all activities required to initiate, monitor, and complete clinical research studies. • Assist with study materials including but not limited to, the informed consent document, case report forms (CRFs), screening and enrollment logs, and device accountability logs. • Confirm study procedures are performed in compliance with SOP’s, institutional and federal regulations, and using good clinical practice. • Perform specimen processing and shipment… Show more • Plan, design, coordinate and conduct all activities required to initiate, monitor, and complete clinical research studies. • Assist with study materials including but not limited to, the informed consent document, case report forms (CRFs), screening and enrollment logs, and device accountability logs. • Confirm study procedures are performed in compliance with SOP’s, institutional and federal regulations, and using good clinical practice. • Perform specimen processing and shipment of biological specimen duties. • Establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required. • Coordinate and attend sponsor prequalification visits, monitor visits, study termination visits. • Screen, recruit and enroll patient into the Emergency Department’s active research protocols. • Collect, label and process biological specimens and vital signs. • Participate in the informed consent process by obtaining appropriate signatures and dates on forms. • Work with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals. Show less • Plan, design, coordinate and conduct all activities required to initiate, monitor, and complete clinical research studies. • Assist with study materials including but not limited to, the informed consent document, case report forms (CRFs), screening and enrollment logs, and device accountability logs. • Confirm study procedures are performed in compliance with SOP’s, institutional and federal regulations, and using good clinical practice. • Perform specimen processing and shipment… Show more • Plan, design, coordinate and conduct all activities required to initiate, monitor, and complete clinical research studies. • Assist with study materials including but not limited to, the informed consent document, case report forms (CRFs), screening and enrollment logs, and device accountability logs. • Confirm study procedures are performed in compliance with SOP’s, institutional and federal regulations, and using good clinical practice. • Perform specimen processing and shipment of biological specimen duties. • Establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required. • Coordinate and attend sponsor prequalification visits, monitor visits, study termination visits. • Screen, recruit and enroll patient into the Emergency Department’s active research protocols. • Collect, label and process biological specimens and vital signs. • Participate in the informed consent process by obtaining appropriate signatures and dates on forms. • Work with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals. Show less



Northeast Clinical Services

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Clinical Support Specialist

  • Jun 2014 - Nov 2014

  • Maintain clinical files and documents according to professional standards. • Contact primary nurses to ensure patient re-certification packets are sent and received in a timely manner. • Organize and maintain clinical records, files, patient and nurse communications. • Maintain clinical files and documents according to professional standards. • Contact primary nurses to ensure patient re-certification packets are sent and received in a timely manner. • Organize and maintain clinical records, files, patient and nurse communications.



Fenway Tan

• Greater Boston Area

• Manager

  • Jan 2011 - Jul 2014

  Responsible for planning, directing and overseeing the operations of the company, as well as implementing work procedures and policies. Encourage the optimum performance of the company’s employees and delegated responsibilities to the team. Responsible for maintaining and exceeding standards of excellence in Guest Service, client retention and staff proficiency. • Ensure facilities are clean and well-maintained. • Increase business by developing promotion and marketing campaigns. •… Show more Responsible for planning, directing and overseeing the operations of the company, as well as implementing work procedures and policies. Encourage the optimum performance of the company’s employees and delegated responsibilities to the team. Responsible for maintaining and exceeding standards of excellence in Guest Service, client retention and staff proficiency. • Ensure facilities are clean and well-maintained. • Increase business by developing promotion and marketing campaigns. • Analyze weekly and monthly sales figures and expenses. • Ensure facility operates to all safety and regulatory guidelines. Show less Responsible for planning, directing and overseeing the operations of the company, as well as implementing work procedures and policies. Encourage the optimum performance of the company’s employees and delegated responsibilities to the team. Responsible for maintaining and exceeding standards of excellence in Guest Service, client retention and staff proficiency. • Ensure facilities are clean and well-maintained. • Increase business by developing promotion and marketing campaigns. •… Show more Responsible for planning, directing and overseeing the operations of the company, as well as implementing work procedures and policies. Encourage the optimum performance of the company’s employees and delegated responsibilities to the team. Responsible for maintaining and exceeding standards of excellence in Guest Service, client retention and staff proficiency. • Ensure facilities are clean and well-maintained. • Increase business by developing promotion and marketing campaigns. • Analyze weekly and monthly sales figures and expenses. • Ensure facility operates to all safety and regulatory guidelines. Show less



Brigham and Women's Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Research Intern

  • Jun 2013 - Dec 2013

  Assisted team on existing and potential new research studies. Participated in meetings and lectures on innovative research topics. • Development of Polish paradigm for functional MRI scans. • Prepare written report summarizing research and case study on a patient. • Explore fMRI scans using NordicBrainX software. • Attend lab meetings that discussed future innovation in healthcare. • Participate in multiple active neurology studies in Dr. Alexandra Golby’s lab. • Observe… Show more Assisted team on existing and potential new research studies. Participated in meetings and lectures on innovative research topics. • Development of Polish paradigm for functional MRI scans. • Prepare written report summarizing research and case study on a patient. • Explore fMRI scans using NordicBrainX software. • Attend lab meetings that discussed future innovation in healthcare. • Participate in multiple active neurology studies in Dr. Alexandra Golby’s lab. • Observe several neurological operations held in the state of the art Advanced Multimodality Image Guided Operating Room (AMIGO) suite. Show less Assisted team on existing and potential new research studies. Participated in meetings and lectures on innovative research topics. • Development of Polish paradigm for functional MRI scans. • Prepare written report summarizing research and case study on a patient. • Explore fMRI scans using NordicBrainX software. • Attend lab meetings that discussed future innovation in healthcare. • Participate in multiple active neurology studies in Dr. Alexandra Golby’s lab. • Observe… Show more Assisted team on existing and potential new research studies. Participated in meetings and lectures on innovative research topics. • Development of Polish paradigm for functional MRI scans. • Prepare written report summarizing research and case study on a patient. • Explore fMRI scans using NordicBrainX software. • Attend lab meetings that discussed future innovation in healthcare. • Participate in multiple active neurology studies in Dr. Alexandra Golby’s lab. • Observe several neurological operations held in the state of the art Advanced Multimodality Image Guided Operating Room (AMIGO) suite. Show less



Beverly Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Student Internship

  • Oct 2009 - Jun 2010

  Assisted nursery nurses with handling newborns. Observed cardiologist doctors, pediatric doctors, gynecologists, geriatric nurses, maternity nurses, labor and delivery nurses, midwives, and nursery nurses. Volunteered over 70 hours to the hospital. Helped different departments with organization, alphabetizing, assisted with mailing back medical files and x-ray prints. Aided physical therapist with appointment books, files and prepped the patient exam room. Assisted nursery nurses with handling newborns. Observed cardiologist doctors, pediatric doctors, gynecologists, geriatric nurses, maternity nurses, labor and delivery nurses, midwives, and nursery nurses. Volunteered over 70 hours to the hospital. Helped different departments with organization, alphabetizing, assisted with mailing back medical files and x-ray prints. Aided physical therapist with appointment books, files and prepped the patient exam room.