TERESA IRVING NISKANEN

**** **** **** #*** ****:651-***-****

Minneapolis, MN 55344 Cell:651-***-****

E-mail: ac4kb8@r.postjobfree.com

CLINICAL RESEARCH ASSOCIATE

SKILLS

*Monitor activities at clinical study sites to assure adherence to GCPs, SOPs, and study protocols

*Assure regulatory compliance of investigational sites with SOPs and FDA and ICH guidelines

*Assist in the creation and implementation of protocols, informed consents, case report forms, clinical study reports, and related study materials

*Provide guidance, clinical trial management, and direction to clinical study centers

*Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data

*Verification Plan, and Laboratory Manual

*Coordinate and be responsible for the completion of study documentation materials such as CRFs and study reports

*Order and coordinate the study supplies

*Maintain tracking tools

*Assist with selection and management of vendors

*Plan and participate in investigator meetings

*Assist and support data validation and data cleaning procedures

*Assist with site budget negotiations

PROFESSIONAL EXPERIENCE

COVANCE, INC., Princeton, NJ – Aug 2009 - Present

Clinical Research Organization

Position: Senior Clinical Research Associate (Home Based) Studies: Neurology, Respiratory, Endocrinology

*Monitor clinical studies, including evaluation, initiation, routine, and close out site visits

*Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion

*Manage, prepare, send, track, and return investigational supplies at individual sites

*Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities

*Review source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues

*Review data queries and listings, and working with the study centers to resolve data discrepancies

*Maintain complete and accurate study files, and reviewing files to ensure all appropriate documentation is present

*Maintain consistent contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials

*Review the trip reports of other CRAs

PROTRIALS RESEARCH, Mountain View, CA Oct 2007 – Aug 2009 Clinical Research Organization

Position: Clinical Research Consultant (Home Based) Studies: Endocrinology, Device, Oncology

*Monitor clinical studies, including evaluation, initiation, routine, and close out site visits

*Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion

*Manage, prepare, send, track, and return investigational supplies at individual sites

*Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities

*Review source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues

*Review data queries and listings, and working with the study centers to resolve data discrepancies

*Maintain complete and accurate study files, and reviewing files to ensure all appropriate documentation is present

*Maintain consistent contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials

3M PHARMACEUTICALS, St. Paul, MN Aug 2004 – Oct 2007 Global Manufacturing and Pharmaceuticals

Position: Advanced Clinical Research Associate

Studies: Virology, Dermatology

*Independently and accurately performed clinical site monitoring functions and managed additional clinical studies activities

*Submitted a study protocol to an independent central review board on the behalf of 45 study centers to decrease the approval time by 2 weeks

*Created informed consent forms (ICFs) for submission to Institutional Review Boards (IRBs) for approval

*Increased the data transfer rate of a study center 50% by enlisting an outside contractor to resolve system connectivity issues

*Contributed to a study information transfer, study budget verification, and 4th quarter study reporting to facilitate the smooth transition of the regional marketing and intellectual property rights worth an estimated 875 million from 3M Pharmaceuticals to Graceway Pharmaceuticals ICON CLINICAL RESEARCH, Irvine, CA May 2002 – Aug 2004 Clinical Research Organization

Position: Clinical Research Associate

Studies: Endocrinology, Cardiology, Neurology

*Identified, selected, initiated, closed appropriate investigational study centers for clinical research studies

*Authored study initiation visit procedures that decreased the time spent conducting initiation visits by 2 hours

*Implemented improved screening techniques that increased enrollment 10% by identifying roadblocks to study subject enrollment

*Reduced travel costs and time away from the office by making travel arrangements 10-21 days in advance and collectively scheduling study center visits

*Maximized my productivity during my time spent at a study center, by reviewing materials and familiarizing myself with center specific issues before the visit

*Improved client relations with study centers by providing targeted guidance to questions regarding protocol procedures

CITY OF HOPE NATIONAL MEDICAL CENTER, Duarte, CA Feb 2001 – May 2002 National Cancer Institute Comprehensive Cancer Center Position: Clinical Research Associate

Studies: Oncology, Pediatrics

*Compiled, registered, and submitted data to monitor study compliance, enhancing workflow, and meet analysis deadlines

*Accelerated the rate of data collection 20% by implementing the use of a software system to “mine” and retrieve information

*Decreased the turn-around-time of clinical results 24 hours by establishing a procedure to track and retrieve missing specimens

*Coordinated the completion of data collection by 24 clinical research associates for presentation to the 2001 Southwest Oncology Group

EDUCATION

College of St. Teresa, Major: Biology, Degree: BA

Pasadena City College, Major: Business, Degree: Certificate AFFILIATIONS

Association of Clinical Research Professionals (ACRP)

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