Cinical Research Associate

David Krause

Boston, MA *****

Tel: 617-***-**** ********@*****.***

EDUCATION AND CLINICAL RESEARCH TRAINING:

CITI Program Training

Certification in Protecting Human Research Subject

Certification in HIPAA

Certification in Good Clinical Practices

Certification in IATA

The CRA Training Institute 2015 Houston Texas USA

CRA Professional Development Certificate Program

ICH GCP Training

Clinical Site Monitoring (site selection, initiation, monitoring and close out)

Uppsala University, Uppsala, Sweden

Master’s in medical science, International Public Health June 2010

University of Massachusetts, Boston MA

Bachelor of Science, Management Science, and information Systems June 2003

PROFESSIONAL EXPERIENCE:

Umass Medical School - Worcester MA

Center for Clinical and Translational Science

Coordinator Clinical Research January 2021 – Present

Work during the COVID-19 pandemic with a research team that is conducting clinical trials on the successful emergency use authorization of the Moderna and Pfizer-BioNTech COVID-19 vaccines

Assisted in COVID-19 trials including regulatory, recruitment and data entry

Communicate with subjects with severe symptoms and direct them to go to the ER as per protocol requirements

Participate in the development of protocol specific tools, (e.g., treatment data and/or therapeutic checklist)

to aid with data submission

Extract and transcribe treatment data from hospital and clinical records required to complete study patient’s record and sponsors’ case report forms. Monitor’s quality and timelines of data submissions

Monitor status of all studies in database and ensures that all patient data (on-study and follow-up) are submitted, and respond to data queries from sponsoring organization, in a timely manner

Track and maintain accurate data of studies, accrual, and patient status activity in database

Maintain effective working relationships with research nurses and investigators participating in the study

Monitor strict adherence to protocols. Assure that cases are being finalized and reviewed by appropriate clinician

Review protocol requirements with physicians and research nurses. Identify and resolve issues with protocol compliance. Keep principal investigator and the research nurse aware of any issues on compliance

Ensure that protocol document has current amendments. Inform staff and updates database

Provide data to study investigators as requested and submits data for analysis. Run quality control checks on data prior to transfer

Serves as a resource to physicians and nurses to locate information for special reports and treatment decisions

Adheres to Good Clinical Practice (GCP) guidelines and all human subject’s protection practices

Takeda Pharmaceuticals International Co – Cambridge MA

Clinical Research Assistant (Contract) (GMA-OBU) August 2019 – January 2020

Work closely with field staff, local representatives, Principal Investigators with his staff to ensure appropriate submissions of all required study documents

Assisted in preparation of the study, organized the study files and documents to ensure good startup of the investigation sites and updating of Trial Master File (TMF)

Contributes to preparation and participating in internal review and governance committees for IISR concepts, protocols, and Study Progress Review Meetings

Coordinating with investigator /site for study updates and receipt of publications/study reports

Submitting and maintaining milestones in IISR system (Vision Tracker)

Obtain confidential agreements and assist with study drug management and approval process

Ensures communication and information sharing occurs between cross functional groups and study sites as appropriate

Assists with performing follow up to gain additional information for Fair Market Value assessments

Budget review, payment schedule, and budget reconciliation at study closure

Centogene US LLC – Cambridge MA

Clinical Research Associate January 2019 –June 2019

Assisted in the selection of sites, site evaluation, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites

Assisted in preparation of the study, organized the study files and documents to ensure good startup of the investigation sites and updating of Total Master File (TMF)

Performed training for site staff in all study procedures to ensure protocol/ICH-GCP compliance

Managed trail materials (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to site

Promptly addressed project Management Team about any issues that can jeopardize the conduct of the clinical project assigned

Conducted and reported periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of Case Report Form (CRF) in compliance with the protocol, SOP’s and ICH-GCP requirements to ensure data integrity and subject safety

Massachusetts Medical office - Bulfinch (Partners Healthcare) Boston, MA

Credentialing Coordinator March 2016 – January 2019

Prepares, in a timely manner, all applications for reappointment for distribution to the various Services

After appointment/reappointment decision is reached, updates existing files to reflect new status and approval at Credentials/MEC/Board of Trustee meetings

Adhere to office procedure, updates electronic database and a resignation correspondence

Maintaining current knowledge of credentialing software used by the department.

Center for Integrated Diagnostics Bulfinch Temps (Partners Healthcare) Boston, MA

Clinical Lab Assistant September 2015 – February 2016

Organized slides for pathologists to review and records the pathologist’s annotations

Worked closely with other CID Lab Assistants to solve any issues with specimen retrieval that may arise

Requested specimens needed for testing from MGH pathology for clinical testing and research purposes.

Facilitated histology processing, pathology review and diagnostic testing by safely and efficiently delivering materials to appropriate locations

Documented information associated with patient specimens, testing and inquires.

Understood OSHA, JHACO, HIPAA, D.P.H principles and practices

TIMI Group – Bulfinch Partners Healthcare Boston, MA

Clinical Research Safety Administrative Assistant October 2013 – August 2015

Entered participant’s information into database and analyze research questionnaires/Graphs

Maintained case files according to department, study, FDA requirements and working knowledge of ICH- GCP

Reviewed safety study files for extraneous documents and to ensure required documents are present

Assisted with eTMF migration from Trial Interactive to Veeva Vault by creating mapping sheets that were used to migrate the document from the shared drive to Veeva Vault

Prepared and send standard e-mail communications to sites regarding query follow up

In-depth knowledge and experience in clinical research monitoring

Harvard School of Public Health, (Food Plate Program) Boston, MA

Research Assistant March 2013 – June 2013

Obtained Consent from participants

Collected and analyzed students Data

Recorded foods selected by student into project database

Weighed and recorded students’ leftover foods after lunch period

Evaluated the influence of Smart Lunchroom Techniques and encouraging student to select healthier foods

SKILLS:

Fluent in French

Understanding of OSHA, JHACO, HIPAA, D.P.H. principles and practices

Proficiency in computer applications Microsoft Office, Medidata, Impala V 2.0, Preclarus Portal, Vision Tracker, Leads, SPSS, EPIC, TMF, End Note, People Soft, ePiP, Cirbi, End Point, Wiki Lims, MedDRA and SharePoint

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