Customer Service Data Entry
Resume:
Tammy J. Dammann
Oak Grove, MN 55011
************@*****.***
OBJECTIVE
As a dedicated and committed employee who thrives on challenges, my ability to adapt to new situations quickly sets me apart from the rest.
My goal is to secure a challenging position, where my work experience and training will help to create a quality product and provide me with growth potential.
PROFESSIONAL EXPERIENCE
2016-Present USF Holland- 2016-Present
Office Administrator
Customer service (appointment scheduler,
Accounting representative
2014-2016 Freelancer
Create CRFs from protocols
Clinical data entry
2010-2014 St. Jude Medical
Clinical Research Associate II
Organize New Clinical Studies
Act as primary author of clinical study protocols and supporting documents (informed consent, case report forms, training materials, etc) for small to large studies.
Ensures IRB approval is obtained at all sites.
Participates in site qualification process and training of clinical investigators and study coordinators with respect to protocol and data submission requirements.
Responsible for completing appropriate Study Organizer forms (i.e. Request for CRD number, Request for Initial Study Organizer Information, etc)
May represent the clinical department on new product development teams.
Responsible for negotiation of research contract and financial agreements.
Writes and/or provides input to the monitoring plan.
Assists with Clinical Trial Committees (member selection, member communication, contracts, etc), management of core labs (core lab selection, contract negotiations, etc.), planning and preparing materials for Investigator Meetings
Supervise ongoing clinical studies
Performs site initiation visits and close out visits
Coordinates and conducts monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
St. Jude Medical cont.
Tracks and reports progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events and protocol deviations. Provides updates on progress of assigned clinical sites to study management.
Responsible for accurate, complete and timely data submissions by clinical investigators and implementation of corrective action, if necessary.
Assists the Clinical Trial Coordinator with the investigational site compensation programs.
Supports investigators wishing to publish or present their experience with company products.
Prepares and submits forecasts of investigational devices to Manufacturing to assure adequate supply, and maintains records of device shipment and storage.
Reports and gains approval for any protocol changes or deviations.
Reviews clinical data for completeness and identifies any adverse effects.
Reports unanticipated adverse effects to Regulatory Affairs and Quality personnel.
Authors or co-authors appropriate sections of clinical summary sections of manuscripts for these trials.
2002-2010 Acorn Cardiovascular lnc.- St. Paul, Minnesota
Clinical Research Associate, Assistant
Assist in design and development of IDE study protocols, case report forms, study manuals, and other study tools
Manage, maintain and report progress of ongoing studies in the US and Europe
Monitor clinical investigational sites to ensure compliance with clinical protocol and FDA, HIPAA, ICH, and GCP regulations
Manage the collection of regulatory documents to ensure site and sponsor compliance
Manage device accountability for studies
Provide on-call help for sites
Maintain study files in accordance with company WIs, GCPs, and FDA regulations
Manage clinical trial agreements-payments
Manage Study related Core Labs
Maintain accountability of world-wide usage of approved devices
Assisted in the training and supervision of staff
Managed in-house monitoring of clinical study data to identify/resolve discrepancies, resolve data queries and obtain missing data
Assisted with programming specifications for data reports
Generated data reports
2002-2004 Clinical Data Coordinator
Managed data entry of Case Report Forms and Data Clarification Forms for multiple studies: domestic and international
Managed data reconciliation/double-key verification of database records and was final data arbitrator
Managed administration and running of automated consistency checks
1997-2002 Self Employed - Becker, Minnesota
Custom Builder
New construction turnouts as a subcontractor
1992-1997 Holiday Companies,
Merchandising Account Technician
Set up STS operating system as part of accounting reconstruction resulting from buyout of Gander Mountain by Holiday Companies
1992-1997 Accounts Payable Clerk
Data entry
Organized and processed accounts payable checks
Filed invoices and other department records
EDUCATION
1986-1988 Rasmussen Business College Eagan, Minnesota
Continuing Education/Additional Training:
Advanced Monitoring workshop
Clinical Research 101
Med Edge 2004 International Conference
Comprehensive Monitoring for Medical Devices
Anatomic, Physiologic and Pathologic Basis of Cardiovascular Devices
Clinical Studies for Medical Devices
Reimbursement Fundamentals in Clinical Trials
Fundamentals of Clinical Research
Database/Data Processing Skills:
Software: Great Plains, Quicken Books, GTS, STS, Lotus, Excel and Access
Operating systems: Windows NT, OS X
References available upon request
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