Clinical Research Management

ILLA COLLINS-KASPER RN

*** ***** **** *****

Winnipeg, Manitoba

R2E 0H7 204-***-****

*****************@*****.***

CLINICAL RESEARCH SPECIALIST

Senior Clinical Research Associate with extensive research and regulatory experience.

Responsible for supervising and monitoring Clinical Trials to ensure absolute adherence to good

clinical practice in accordance with the ICH-GCP standards, Declaration of Helsinki, Federal

Regulations and study procedures.

Functions as a project/site manager ensuring timelines are met, and budget adhered to.

Management of all study related activities from feasibility assessment through study closure.

Seeking contract work as an Independent Clinical Research Specialist

PROFESSIONAL EXPERIENCE

BRISTOL-MYERS SQUIBB CANADA

2013- PRESENT

CLINICAL SITE MONITOR

• Implemented all aspects of Clinical Trial Management-Phase I-IV from inception to

completion

Monitor study sites following the Monitoring Plan, BMS SOP’s, protocol, ICH/GCP

•

Guidelines and local regulations as applicable.

Managing multiple protocols across multiple therapeutics areas

•

Ensures safety and protection of study subjects and ensures quality of data submitted

•

from study sites and assure timely submission of data by utilizing the available systems

to follow site activities.

Supervising overall activities of site personnel to motivate/influence them to meet study

•

objectives and for the resolution of any study site problems/issues as they occur, and

ensures documented follow-up to all outstanding issues/corrective actions.

BAYER HEALTHCARE PHARMACEUTICALS, 1999-2012

SENIOR CLINICAL RESEARCH ASSOCIATE/SITE MANAGER

Implemented all aspects of Clinical Trial Management-Phase I-IV from inception

to completion

Acted as liaison between clinical sites and Bayer Project Team, as well as with

Sales, Marketing, Scientific Affairs and Government and Public Relations.

Responsible for ongoing compliance with protocols, SOP’s and applicable

ICH/GCP guidelines and regulations.

Prepared, reviewed and approved of country specific patient informed consent

form.

Local Contract and Budget Management including creation, negotiation and

execution.

Maintained and tracked study costs, prepared study payments and monthly accruals.

Updated IMPACT at country level, preparation of monthly reports, study updates and

newsletters.

Liaised with study team members and investigator sites; prepared and presented

monthly updates to team members and clinical operations group.

HEALTH SCIENCE CENTER/UNIVERSITY OF MANITOBA, WINNIPEG, MANITOBA. 1997 - 1999

RESEARCH NURSE/STUDY COORDINATOR, DIABETES RESEARCH GROUP

Involved in multiple clinical trials testing medication for the prevention of diabetes and

its complications, new pharmacological treatment for Type I and Type II diabetes and

basic scientific research.

Collaborated with the principal investigator in recruitment, assessment of potential study

candidates and obtaining informed consent.

Performed all tasks related to ongoing management of clinical trials including patient

education, drug administration and accountability, specimen collection and organization

of diagnostic procedures.

Conducted ongoing assessments of clinical management of patients involved in clinical

trials while maintaining standards of good clinical practice.

EDUCATION AND TRAINING

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS-PROJECT MANAGEMENT

BAYER REGULATORY DEPARTMENT-NEW HEALTH CANADA REGULATIONS

D. TYNDALL AND ASSOCIATES-GCP TRAINING

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS-ISSUES IN CLINICAL RESEARCH “RULES, ROLES AND

RESPONSIBILITIES: PREPARING FOR A REGULATORY INSPECTION

D. TYNDALL AND ASSOCIATES-HOW TO PREPARE FOR A SPONSOR AUDIT

CREATENET-ICH GUIDELINES AND FDA REGULATIONS

CBO TRAINING GROUP-LEADERSHIP THROUGH PEOPLE SKILLS

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS-INTERMEDIATE CLINICAL RESEARCH ASSOCIATE

TRAINING

HEALTH ASSESSMENT OF INDIVIDUALS, BACHELOR OF NURSING PROGRAM, UNIVERSITY OF MANITOBA

ADVANCED CARDIAC LIFE SUPPORT, UNIVERSITY OF MANITOBA

INTENSIVE CARE NURSING PROGRAM, ST. BONIFACE HOSPITAL, WINNIPEG, MB.

HEMODIALYSIS NURSING PROGRAM HEALTH SCIENCES CENTER, WINNIPEG, MB.

NURSING DIPLOMA GRADUATE, MISERICORDIA GENERAL HOSPITAL SCHOOL OF NURSING

GENERAL PROFICIENCY IN NURSING AWARD

AFFILIATIONS

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS SOCIETY OF CLINICAL RESEARCH ASSOCIATES

CLINICAL RESEARCH NURSING NETWORK COLLEGE OF REGISTERED NURSES OF MANITOBA

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