HIRA SHRESTHA, MA, BS
hishresh@gmail.com | 207-776-5526 | Somerville, MA
Professional Summary
Experienced Research Project Manager with 13 years in the field, including 7 years in research oversight and project management. Expertise spans diverse therapeutic areas, such as Oncology, Neurology, OB/GYN, and Pediatrics/Neonatology. Skilled at leading cross-functional teams to achieve project goals within urban academic hospital settings. Currently pursuing PMP certification, expected in July 2025.
Key Experiences
- Clinical Trials & Projects Management
- CBER and CDER application
- Regulatory responsibilities management
- Research budget development and oversight
- Vendor selection and management
- Contract review and oversight
- Database development and management
- Line Management
- Internal/External site start-up/Close-out
- Grant application preparation and submission – Federal, Foundation, Industry, Institutional
- Trial Protocol and operational documents development
- ClinicalTrials.gov profile creation and reporting
- Skilled in various administrative, management, and clinical software
Current Positions
MASS GENERAL HOSPITAL (MGH) – NEUROLOGY DEPARTMENT, Boston, MA
Sr. Clinical Research Program Manager – McCance Center for Brain Health
April 2023 – Present
I joined McCance Center for Brain Health in April 2023 to support center’s newly formed Clinical Trials Unit with setting up clinical trials infrastructure to run platform trials targeting prevention of Alzheimer’s disease using repurposed market drugs and natural product combinations. This effort involved identifying internal/external stakeholders and resources that could be leveraged to efficiently and cost-effectively run these trials using federal, foundation, and institutional grants. Majority of my time at McCance so far has been devoted to understanding ever-evolving institutional research infrastructures; developing center’s trial management plans and SOPs; biomarker and investigational product vendor identification, communication, and contracting; IRB submissions; several grants submission; trial budgets development; trial start-up activities under Mass General Brigham regulatory guidelines; and bi-weekly faculty seminar management.
Key contributions & responsibilities
- Working with leadership to develop clinical research infrastructure and portfolio development including brain nutrition and Alzheimer’s Disease prevention trials
- Supporting staff development efforts
- Putting together detailed clinical trials budget as well as grant application packets for several federal, foundation, and institutional grants with amount ranging in 2 to 28 million for 3-5 years trials.
- Selecting and setting up internal and external Alzheimer’s Disease and nutrition biomarkers vendors
- Leading trial start-up activities in compliance with federal and institutional guidelines
- Overseeing and assisting with development of trial documents such as CRFs and implementing them.
- Developing integrated study management plans with the core project team.
- Collaborating with other functional groups within the institution where necessary to support milestone achievement and to manage study issues and obstacles.
- Developing trial regulatory management plan and supervising regulatory activities
- IRB submission and assistance with FDA correspondence as needed
- Managing trial database development and implementation in collaboration with team.
- Managing all aspects of bi-weekly McCance Center Faculty seminar series that involved developing detailed SOP for effecting management of the seminar workflows that included generating seminar dates a year in advance, managing speakers, maintaining distribution list, collaborating with institutional communication department to post videos, etc.
- Aiding with trial dissemination efforts and delivering any other administrative assistance as needed.
BRIGHAM AND WOMENS HOSPITAL – PEDIATRIC NEWBORN MEDICINE, Boston, MA
Research Specialist – Newborn Assessment Examiner
Oct 2019 – Present
I am a certified NICU Network Neurobehavioral Scale (NNNS) examiner. I joined BWH to work as a Newborn Assessment specialist to train qualified study staff to conduct NNNS and also serve as a backup NNNS examiner for NIMH funded study investigating postpartum developmental outcomes of infants born to mothers experiencing some level of psychiatric conditions such as depression or psychosis. I also provide NNNS related consultation as needed.
