Damaris Holloway.

Dover, New Jersey *****

973-***-****

Email: adfzlu@r.postjobfree.com

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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