Shruthi Sudhakar, Ms Email & Phone Number

Boston, Ma, Us

Responsible for the oversight of the program's clinical research portfolio and all related regulatory, compliance and performance metrics requirements.Serves as Clinical Research Study/Trial Manager for clinical studies.Supervises research study staff and maintains staff performance reviews. Works with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.Oversees the processing of protocols through BCH Institutional Review Board (and other institutions' IRBs) when appropriate.

Us

In addition to previous duties as Senior Research Assistant: Monitors data collection, project milestones, and prepares progress reports to ensure project deadlines are met.Assists in grant reporting and the preparation of grant applications.Provides oversight for the Lab Accreditation Policies, Procedures, and Inspection Process. Ensures regulatory compliance of lab activities through equipment and chemical inventory audits.Handles coordination and implementation of the research design process which may involve multiplestudy sites.Assists with research posters, presentations, and/or article submissions.Navigates institutional research resources needed for the research operations of the division, includingcore services.Responsible for IRB Policy and compliance and reporting as it relates to National Institutes of Health(NIH), Department of Defense (DOD), philanthropic funding, MGB Policy and Mandates.

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OB/GYN Epidemiology, BWH Department of Obstetrics and Gynecology - Boston Center for Endometriosis Acted as lead research assistant for the Boston Center for Endometriosis BiorepositoryCoordinated and managed various laboratory projects including specimen processing (blood, urine, saliva, peritoneal fluid & tissue). Oversaw day to day lab operations, including inventory management and preventative maintenance of laboratory equipment such as centrifuges and -80 C freezers. Supervised research assistants and interns and was responsible for staff schedule planning. Scheduled and conducted research visits with enrolled study participants. Responsible for data entry/management/cleaning, designing/editing of REDCap questionnaires, medical record abstraction/coding. Wrote IRB protocols for new research projects and assisted in project implementation and management.

Boston, Ma, Us

All of Us Research Program, New England Consortium Operations TeamResponsible for training of all new research coordinators and maintenance of regulatory materials (39+ new hires beginning Jan 2021.)Acted as Lead Training Coordinator and oversaw Training Team. Coordinated 90 day training plan for all new hires and managers, including scheduling of phlebotomy training, software training, and site specific activities. Helped train all program staff on new program specific software and workflows.Wrote Standard Operating Procedures for daily Operations Team activities, streamlined workflows and adapted activities to national program protocol updates.

Boston, Ma, Us

All of Us Research Program, New England Consortium Newton Wellesley Hospital Site Team & Operations TeamCommunicated objectives of the program to potential study participants and participated in recruitment, retention and engagement activities at multiple hospital and community based clinics.Participated in inpatient and outpatient recruitment efforts at Newton-Wellesley Hospital.Conducted data validation through program specific software, including Salesforce, REDCap, and EPIC. Made phone calls to potential participants and tracked incoming calls from study participants. Scheduled appointments, handled visit reminders and confirmations, and edited email templates for study activities as needed.Assisted with electronic informed consent and computer assisted telephone interviews for study surveys.

Cambridge, Ma, Us

Assisted Laboratory Manager with daily tasks including shipping & receiving, restocking of laboratory materials, and preventative maintenance of laboratory equipment.

New York, Us

Ran blog, social media and calendars for academic program and managed program office;Executed health and wellness programming for international residential students;Assisted program staff with inventory and tracking of all program materials and equipment;Created a fun and positive environment for students through daily chaperoned activities and events.

Performed manual DNA extraction from patient samples (plasma/buffy coat/serum isolation);Accessioning of patient samples using STARlims, general lab responsibilities; cleaned, stocked and organised lab consumables and reagents;Shadowed use of Flexstar, Tecan, Autopure, Hi-Seq, Tecan/Allelic Discrimination machinery;Contributed suggestions to ongoing process improvement efforts.

Bachelor'S Degree, French Studies

Master Of Science - Ms, Regulatory Science

Graduate Certificate, Biotechnology Management

Certificate, Medical Interpreting

High School Diploma