Clinical Research Associate, Clinical Research Coordinator

WORK EXPERIENCE

Biofortis-Provident Clinical Research Addison, IL Clinical Research Coordinator, CCRC October 2011 – Present

Summary: Possesses the ability to run all aspects of clinical research trials in accordance with protocols and in compliance with the organization’s Standard Operating Procedures, policies, and applicable laws.

Essential Duties and Responsibilities:

Responsible for recruiting, screening and enrolling clinical study participants

Obtains proper written informed consent from each study participant prior to participation in the study

Schedules and complete defined activities of the studies completely and accurately

Develops source documents and tools specific to the protocol

Accurately completes source documents/case report forms

Accurately completes study medication and product accountability

Briefs and trains current and new staff on all operational policies and procedures of the study, ensuring each person understands his/her role and responsibilities in the study

Meets and communicates with the Sponsor and /or their designee regarding the conduct of the study

Inform Institutional Review Board and Sponsor as appropriate of relevant adverse events

Responsible for ensuring that the clinical trial is conducted according to the investigational plan (protocol) and Good Clinical Practices

Successfully interacts with clinical research team

Maintain a high level of knowledge and understanding of assigned protocols

Communicates frequently with outside vendors and agencies to ensure all study-specific procedures are completed properly

Monitors and maintains timelines, study conduct, and ensures prompt completion of study activities

Collects ECGs, vital signs, adverse events, and concomitant medication information

Performs sample collection of both PK and safety labs

Regularly corresponds and assists with Sponsors/clients in a professional and timely manner

Perform Quality Control review of study materials to ensure information is accurate and true

Certificates, Licenses, Registrations: Certified Clinical Research Coordinator, Association of Clinical Research Professionals, CPR/ADD, NIH “Protecting Human Research Participants” Certificate, Mayo Clinic “Shipping of Category A, Infectious Substance Affecting Humans/Category B, Biological Substance Training”

Computer Proficiency:

MS Office

Windows XP/Vista/7

Internet Explorer

CernerWorks/LabDAQ

Study Monitor

EScribe

Electronic Case Report Forms/Data Entry Programs (InForm, Medidata, Oracle, RAVE, etc)

Suburban Lung Associates SC Elk Grove Village, IL

Clinical Research Coordinator, CCRC

May 2011 – December 2011

Essential Duties and Responsibilities:

Responsible for coordinating successful clinical drug trials by working under supervision of the Principal Investigator and Research Committee to ensure protocol compliance

Assists in study site selection process

Responsible for study start-up process, submitting regulatory documents, budget negotiations, and coordination of clinical drug and device trials

Responsible for screening and enrolling patient candidates for study eligibility

Creates study-specific source documents to sufficiently capture all required study information

Ensures the integrity of the source documentation is accurate and true

Follows and monitors patients in the clinic and thoroughly documents all data in a timely manner

Communicates frequently with outside vendors and agencies to ensure all study-specific procedures are completed properly

Monitors and maintains timelines, study conduct, and ensures prompt completion of study activities

Collects ECGs, vital signs, adverse events, and concomitant medication information

Performs sample collection of both PK and safety labs

Accurately enters source documentation onto case report forms and reviews source documents and case report form entries

Regularly corresponds and assists with Sponsors/clients in a professional and timely manner

Perform Quality Control review of study materials to ensure information is accurate and true

CETERO RESEARCH Fargo, ND

Clinical Research Coordinator, CCRC

June 2007 – May 2011

Essential Duties and Responsibilities:

Demonstrated working knowledge of protocols, study activities, SOP’s, Good Clinical Practice and FDA regulations

Collaborated with Investigators and Sub-Investigators for successful research trial completion

Able to identify, define, and resolve study, participant, and staff issues in a timely manner with the knowledge of when to consult Senior Management for assistance

Regularly corresponded and assists with Sponsors/clients in a professional and timely manner

Performed Quality Control review of study materials to ensure information is accurate and true

Satisfied Quality Control and Quality Assurance’s queries to case report forms and source documents in a timely manner

Assisted in training Clinical Study Monitors, phlebotomists, and safety monitors

EDUCATION

Walden University

Online Program

Clinical Research Administration, Master’s of Science

January 2012 - Present

North Dakota State University

Fargo, ND

Microbiology, Bachelor’s of Science

August 2004 – December 2006

Leadership Activities & Achievements:

Graduated Cum Laude

Dean’s List

Phi Kappa Phi Honor Society

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