Clinical Research Associate II
Resume:
Damaris Holloway.
Dover, New Jersey *****
Email: ***************@*****.***
Experience with Oncology studies ( ITP, NHL, CLL, Pancreatic, Breast Cancer, Colorectal Cancer, NSCLC, SCLC), first in man, Phase I/II trials. Knowledge of cGCPs and regulatory requirements, Ability to understand medical terminology, Excellent written and verbal skills, Bilingual, Detail oriented, Ability to prioritize, Self -motivated, ability to work independently and within a team environment. Proficiency in; Microsoft office, ClinTrial, Oracle Plus, Epower 6.1, Access database
Therapeutic Areas: Oncology and Hematology
Experience:
9/2012 – 1/2019 Immunomedics, Inc
Morris Plains, New Jersey
Clinical Research Associate II
Responsible for conducting study routinely monitoring visits for multiple protocols with multiple sites to ensure cGCPs and study procedures
Presented site study protocol at site initiation visit and site staff training
Performed site close-out visits, ensuring all outstanding issues were resolved prior to sending the site close-out letters
Coordinated and reviewed the start-up regulatory documents, as required by SOP regulations
Ensured all study drug shipments and study trials supplies were accounted for
Reviewed CRFs pages to ensure accuracy and completeness before approval and sending for printing
Assisted Clinical Safety manager with the reconciliation of SAEs reported
Point of contact for investigator/site personnel
Participate in departmental team meetings to discuss status of subject participating in the sponsor clinical trials
Analyzed the screening data for potential patient’s recruitment
Processed payments for patients visits, per budget agreement
Assisted Data Manager to ensure all data queries generated were resolved in a timely manner
Generated site visits reports after each site visits documenting the findings on the monitoring reports
Responsible for identifying and addressing all protocol deviations occurred during the subjects’ participation in the clinical trials
Verified and ensured that all regulatory documentations filed at the clinical sites; as well as sponsor TMFs, were up-to-date
Ensured that all AEs and SAEs reported by the subjects participating in the trial were reported to the sponsor and recorded onto the CRFs, on a timely manner
4/2007 – 9/2012 Senior Clinical Data Specialist
Responsible for data input onto clinical database, from CRF pages for data collected at the sites
Entered all CRF pages received from monitoring visits, into tracking database system
Reviewed CRFs for accuracy
Responsible for database validation
Assisted the data manager with Data listing review/QC
Responsible for the database updates resulting from resolved queries, and listings review
Assisted Data Manager with the Adverse Events/SAEs reconciliation
Generated queries manually to clarify inconsistencies from data recorded on CRFs
9/2006 – 4/2007 Berlex Laboratories (Consultant)
Montville, New Jersey
Clinical Data Manager Assistant
Responsible for working with Leukine Studies
Used E-Power to index CRF pages
Update all databases from CRF Versions involved in QC, managing all data files, SAE & Lab reconciliation, Perform data entry
7/2006 – 9/2006 Eisai Medical Research (Consultant)
Ridgefield Park, New Jersey
Clinical Data Manager Assistant
Performed entry of case reports from data into Clinical Database Version 4.3
Log-in case reportform data and link new patients and new sites to the Clintrial database
Used Excel to maintain the CRF tracking pages
Used to index CRF pages as soon as the CRF pages arrive
9/2005 – 7/2006 Novartis (Consultant / Thru Smith Hanley)
East Hanover, New Jersey
Medical Document Assistant
Responsible for logging, control and processing of CRFs, laboratory reports, dairy cards, Data Query Forms and other related documents. originated from International Clinical Research Organization.
Responsible for maintaining modern filing systems, records
Assisted the Trial Data Managers and/or Field Monitors, to ensure the completeness and accuracy of documentation.
Education:
Certification Raritan Valley Community College (2005 – 2006)
Clinical Research Assistant (CRA)
Clinical Data Management (CDM)
Overview/Electronic Data Management 21 CFR
Management of CFR 11 Compliance
Interpretation of Laboratory Values in Clinical Trials and Developing Clinical Study Management and Monitoring Skills
CCP Trainings
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