1. Alyssa Andreen
5712 Balsam St
Arvada, Colorado
303-961-4445
alyssa.andreen@gmail.com
PROFESIONAL EXPERIENCE
DAVITA CLINICAL RESEARCH Lakewood CO
Clinical Research Project Manager –Site Level May 2012 – Present
Direct Accountability to: Research Manager
Responsible for safe and effective implementation of clinical trial protocols and ensuring that
protocols are conducted, recorded and reported in accordance with the protocol, Site SOP’s and
ICH-GCP and all regulatory requirements
Specific Responsibilities Include:
 Assist with preparation of IRB applications, including protocol, informed consent and
recruitment materials and obtain IRB approval
 Stet up site for Trial conduct including working with outside vendors for supplies and
study sponsors to ensure proper conduct of study.
 Creation and maintenance of source documents and ensure quality of data on CRF’s.
 Create and maintain Regulatory binders; maintain essential and non-essential site
documents ; ensure all GCP documents are filed and current, SOP’s are current and all
regulatory documents meet ICH guidelines
 Train, supervise and evaluate research assistants, research nurses and lab staff in the
performance of their duties. Update training modules as needed and retrain staff.
 Creating study Timelines and meeting minutes ensuring all study timelines are met
 Monitoring all study activities and subject charts and ensuring all everything is in
compliance with protocol requirements and GCP’s
 Monitor case report forms for accurate entry, answer queries and complete data entry.
 Correspondence with sponsor and monitors providing study status updates to team
members including interactions to resolve site issues
DAVITA DIALYSIS Lakewood CO
Dialysis Technician/ Administrative assistant April 2004 - May 2012
Specific Responsibilities Include:
 Managed payroll and end of month financial reports
 Audited patient records for quality assurance in preparation of CMS visits
 Filed patient records in charts and maintained records as required
 Processed requests for medical records worked and submitted all records for patient travel
 Patient care, performing Dialysis treatments, assessing patients, performing venipuncture & ecg’s

2. EDUCATION
Metropolitan State University of Denver
Currently working on completion of BA, 2012 - Present
Red Rocks Community College Lakewood, CO
Associates in Arts, Aug 2006
SKILLS AND EXPERIENCE
 Great organizational skills attention to detail and ability to meet and exceed timelines
 Ability to manage competing priorities
 CCHT certification
 Experience with several EDC systems, such as Medidata, Orical, TrialMaster, and IWRS systens
 Proficient in Power Point, Excel. Word, Microsoft Office and CTMS
 Thorough knowledge of ICH-GCP and awareness of regulatory regulations regarding drug research
 Supervisory experience
References Upon Request