ALANNA SLAEKER

*** ** ***** ****** ******* Way, WA 98023 253-***-**** gy2vdb@r.postjobfree.com

OBJECTIVE: To obtain a clinical research position within a fast-paced, dynamic and challenging organization to successfully utilize my education, skills, and experience. My success has been achieved by my willingness to seize challenges with passion and drive for measurable results.

Summary of Qualifications

• Logical, organized, detail oriented & able to multitask

• Creative, adaptable problem solver

• Excellent written & oral communication skills

• Able to work independently & effectively manage teams

• Talent for organization of clinical documentation • Strong knowledge of FDA regulations & International Conference on Harmonisation(ICH) guidelines, Good Clinical Practices(GCPs) & general industry SOPs

• Solid foundation in medical and scientific terminology

• Clinical Trial Operations

PROFESSIONAL EXPERIENCE

Clinical Research Assistant February 2010 to Present

Nor Consult, LLC Tukwila, WA

• Electronic Capture Data (EDC) Trainer for internal and external personnel

o Developed and created training program and Standard Operating Procedures (SOP)

Online Training Tutorials

Online Training Tools

o Train Clinical Sites on study specific data entry into the database

o Act as a help desk for internal and external personnel regarding all EDC questions

• Clinical Data Management

o Building Study Databases

electronic Case Report Forms (eCRFs) development, testing and validation

Creating eCRF library

o Creation of Case Report Forms (CRFs)

o Review case report forms and clinical data sets for errors, discrepancies and protocol violations

o Oversee validation of instruments for EDC system

• Maintain Good Clinical Practices (GCP)

o Write and revise SOPs and guidelines

• Work with Clinical Research Associates and provide in-house monitoring support for clinical trials

o Provide study start-up materials

o Provide support in the conduct of clinical research studies

Oversee, create and maintain regulatory documents

Organize and track CRF’s, project documents, supplies and enrollments

• Work closely with team for grant applications

o OREF Grant Applications

o NIH Grant Applications

Study Coordinator September 2008 to February 2010

Safety Assessment Department, SNBL USA Everett, WA

• Maintain Good Laboratory Practices (GLP)

• Collaborate with members of the research team in the organization, implementation and completion of clinical trials

• Oversee, create and maintain regulatory documents

• Ensure research projects are conducted in compliance with federal regulations; institutional/departmental guidelines and standards of good clinical practice

• Review scientific raw data for clerical errors, thoroughness and consistency to ensure Good Laboratory Practice

• Coordinate corrections of raw data with research staff

• Respond to Quality Assurance Audits in a timely manner and according to the guidelines established for the trial; documenting recommendations provided to the Investigator addressing corrective actions when needed

• Oversee data entry, spreadsheet validation and data verification

• Train clinical sites on study specific procedures such as specimen collection and shipping

• Writes and revise standard operating procedures

• SOP Mentor

Formulations Technician II July 2008 to September 2008

Test Article Department, SNBL USA Everett, WA

• Responsible for ensuring the success of formulation process and test article documentation of new studies

(GLP & Non-GLP)

• Oversee and conduct emulsification studies

• Improve the overall quality of work to accomplish company goals

• Implement new protocols

Formulations Technician I May 2007 to July 2008

Test Article Department, SNBL USA Everett, WA

• Maintain Good Laboratory Practices

• Prepare and maintain documentation for test article dose preparation

• Perform test article and control article formulation

• Manage all shipping and documentation

• Perform accountability and reconciliation of test materials used in studies

Research Scientist/Engineer I February 2007 to May 2007

Biochemistry DNA Sequencing Facility, University of Washington Seattle, WA

• Set up cycle sequencing reactions

• Column purify sequenced products

• Autoclave plastics for sequencing

• Perform other sequencing related work as required

EDUCATION/PROFESSIONAL MEMBERSHIPS

MEMBER, SOCIETY OF CLINICAL DATA MANAGEMENT 2012-PRESENT

TEAM COMPLIANCE

Auditing Systems for 21 CFR Part 11 Compliance June 2012

UNIVERSITY OF WASHINGTON – Seattle, WA

Clinical Trials Certificate Program – June 2012

SOCIETY OF CLINICAL DATA MANAGEMENT

Data Validation Training– May 2012

UNIVERSITY OF WASHINGTON – Seattle, WA

Bachelor of Science - Neurobiology, August 2006

PIERCE COLLEGE – Lakewood, WA

Associate’s Degree – General Studies, June 2004

Dean’s List Honor Scholar

SKILLS

Microsoft Suite of Products: Word, Excel, Outlook, PowerPoint, Access

Adobe Acrobat 9.0

Pre-Clinical Trial Software: Xybion

Clinical Trial Software: OpenClinica, REDCap

REFERENCES AVAILABLE UPON REQUEST

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