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Renee Reber, RN, MSN, CIP 847-927-5349 (cell); 847-328-2579 (home) 1906 Grant Street, Evanston, IL 60201 [email protected] Professional Profile and Experience Regulatory Compliance and Ethics in Research and Clinical Research Education With over 25 years of experience in nursing, research, education and regulatory compliance, I have extensive knowledge of FDA and NIH research regulations, working within this framework to pursue effective, high quality clinical research and clinical trials, including drug and device trials. I am currently looking for a position that will promote professional growth and utilize my skills and expertise. Rush University Medical Center, Chicago, IL Nov. 2013 to the present, Research Compliance Auditor and Educator, Oncology Research auditing and quality assurance activities to direct and develop education and training; aimed at promoting compliance with federal and state regulations, ethical principles and scientific integrity throughout the Medical Center. Responsibilities: Quality Assessment and Auditing, both for cause audits and not for cause quality assurance reviews. Utilize results to identify trends and conduct risk analysis. Preparation for external pharmaceutical, National Cancer Institute Clinical Trials Monitoring Branch, and FDA external audits. Continuing Education presentations and training on basic research principles, federal regulations and good clinical practice (GCP). Education Program Development to orient and onboard new Research Personnel. Individualized Training and Competency Assessments of Oncology Research Personnel on compliance with research protocols, local policies and procedures and GCP. Standard Operating Procedures (SOP) Development for both the Research Compliance Office and the Cancer Clinical Trials Office. Frequently Asked Questions (FAQs) and Guidance Document Development for Research Personnel and Physicians engaged in Human Subject Research. Mentor/Advisor for Research Administration Master’s Degree Program Students NorthShore University HealthSystem, Evanston, IL Jan. 2000 to Nov. 2013, IRB Specialist and Research RN Clinical Trials Research and Institutional Review Board administration including evaluation of research protocols for compliance with federal and state regulations, ethical principles and scientific integrity, education of research personnel and promotion of high quality research programs throughout the corporation. Page 1 of 5

Renee Reber Resume2 Sept2015

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Page 1: Renee Reber Resume2 Sept2015

Renee Reber, RN, MSN, CIP 847-927-5349 (cell); 847-328-2579 (home)1906 Grant Street, Evanston, IL 60201 [email protected]

Professional Profile and ExperienceRegulatory Compliance and Ethics in Research and Clinical Research EducationWith over 25 years of experience in nursing, research, education and regulatory compliance, I have extensive knowledge of FDA and NIH research regulations, working within this framework to pursue effective, high quality clinical research and clinical trials, including drug and device trials. I am currently looking for a position that will promote professional growth and utilize my skills and expertise.

Rush University Medical Center, Chicago, ILNov. 2013 to the present, Research Compliance Auditor and Educator, Oncology

Research auditing and quality assurance activities to direct and develop education and training; aimed at promoting compliance with federal and state regulations, ethical principles and scientific integrity throughout the Medical Center.

Responsibilities: Quality Assessment and Auditing, both for cause audits and not for cause quality assurance

reviews. Utilize results to identify trends and conduct risk analysis. Preparation for external pharmaceutical, National Cancer Institute Clinical Trials Monitoring Branch, and FDA external audits.

Continuing Education presentations and training on basic research principles, federal regulations and good clinical practice (GCP).

Education Program Development to orient and onboard new Research Personnel. Individualized Training and Competency Assessments of Oncology Research Personnel on

compliance with research protocols, local policies and procedures and GCP. Standard Operating Procedures (SOP) Development for both the Research Compliance Office

and the Cancer Clinical Trials Office. Frequently Asked Questions (FAQs) and Guidance Document Development for Research

Personnel and Physicians engaged in Human Subject Research. Mentor/Advisor for Research Administration Master’s Degree Program Students

NorthShore University HealthSystem, Evanston, ILJan. 2000 to Nov. 2013, IRB Specialist and Research RN

Clinical Trials Research and Institutional Review Board administration including evaluation of research protocols for compliance with federal and state regulations, ethical principles and scientific integrity, education of research personnel and promotion of high quality research programs throughout the corporation.

Responsibilities: Continuing Education presentations and online training regarding research regulations and

human subject protections. Education Program Development to orient IRB members, new Research Institute employees,

and new research coordinators, including a SoCRA certification prep course. Consultation with investigators, residents, students and other research personnel on protocol

development and research design. Regulatory Guidance to update and develop policies, guidance documents, and forms. IRB Support and Management of daily operations and workflow and process upgrades. Protocol Review of Clinical Research Studies for both the Institutional Review Board and the

Oncology Sub-committee. Mentor and Consultant to Nursing Research Council and Research Protocol Sub-council. Supervision and Training of Student interns and Research Institute employees. Quality Improvement and Auditing of over 600 open research trials.

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Page 2: Renee Reber Resume2 Sept2015

Renee Reber, RN, MSN, CIP 847-927-5349 [email protected]

IRB Quality Assurance/Improvement and Metrics, resulting in changes in workflows and IRB staff activities.

Project Management for Phase I, II, and III clinical research studies. Responsibilities included, but not limited to: Coordination and Supervision of a Team of Research Employees, Research Budget Development, Recruitment, Specimen Collection and Sample Processing, IRB Submissions, Study Drug Accountability and Administration, Reporting and Management of Adverse Events, Data Collection, Data Entry, Source Document Creation, and SECHI Computer Protocol Builds.

AmericasDoctor, Gurnee, ILFeb 2001 to Sept 2001, Project Manager

Responsibilities:Research Protocol Feasibility assessment

Research Budget Development and Negotiations for neuroscience clinical research

Harper College, Palatine, ILSep 1999 to Dec 1999, Adjunct Faculty in Nursing

Responsibilities: Clinical Training, Supervision and Evaluation of 1st year nursing students during

Medical/Surgical rotations.

Northwest Community Healthcare, Arlington Heights, ILNov 1998 to Dec 1999, Clinical Nurse Specialist

Responsibilities: Continuing Education for inpatient and outpatient mental health units Orientation and Supervision of new employees Consultation on mental health needs of medical, surgical, obstetric, pediatric, and oncology

patients CME/CEU Educational Programs including Family Psychotherapy conference

Telecare Cresta Loma, Lemon Grove, CAAug 1996 to Aug 1998, Director of Staff Development

Responsibilities: Continuing Education for Psych-Rehab facilities in Southern California CNE Educational programming and training, including development of 8 hour course for

licensed nurses: “Physical Assessment Review for Psychiatric Nurse” and trainer for 16hour course: “Professional Assault Response”

Infection Control monitoring of patients, including policy and procedure updates Quality Assurance and Improvement and Metrics, resulting in reduction in use of restraints Intensive Individualized Care Planning for chronically mentally ill and dually diagnosed patients Crisis Intervention and Debriefing with patients and staff Program Development, including continuing education library and preceptor program for new

employees, and training program interviewing skills. On Call Administrator for weekend coverage

University of California at San Diego, La Jolla, CASept 1993 to July 1995, Research Nurse

Responsibilities: Project Management and Subject Recruitment for study on effects of stress on the immune

system of spousal caregivers of persons with Alzheimer's disease; caseload of approximately 100 subjects from Los Angeles to San Diego.

Data Collection and CRF Completion Sample Collection and Lab Specimen Processing

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Page 3: Renee Reber Resume2 Sept2015

Renee Reber, RN, MSN, CIP 847-927-5349 [email protected]

San Diego City College, San Diego, CA Aug 1994 to Aug 1996, Adjunct Faculty/Assistant Professor of Nursing Education

Responsibilities: Clinical Training, Supervision and Evaluation of 1st & 2nd year nursing students during

Psychiatric, Geriatric and Medical/Surgical rotations. Clinical and Theory Instructor of 1st & 2nd year nursing students. Responsible for course

development and instruction, covering topics related to Nursing Fundamentals, Communication Skills, Geriatric and Psychiatric Nursing.

Community College of Allegheny Count, West Mifflin, PA (1/93-5/93)Jan 1993 to May 1993 Adjunct Faculty of Nursing Education

Responsibilities:• Clinical Training, Supervision and Evaluation of 2nd year nursing students during Psychiatric,

rotations.

Western Psychiatric Institute and Clinic, Pittsburgh, PA Jan 1991 to Nov 1991, Research RN

Responsibilities:• Data Collection and CRF Completion for multiple psychosocial and outcomes research trials. Standardized Psychiatric and Movement Disorders Assessment with older adults.

Forbes Metropolitan Hospital, Pittsburgh, PA Oct 1989 to Aug 1993, Clinical Nurse Specialist (1993), Charge Nurse (1989-1993)

Responsibilities: Acute Medical Care of Geriatric Patients on a specialized unit designed to care for both the

medical and psychiatric needs of patient over age 55. Responsibilities included, but not limited to, medication administration, IV therapy, tracheotomy and G-tube care, wound care, diabetic education, post-chemotherapy care and assessments, first responder, end of life care, transfusions, and basic life support.

Intensive Individualized Care Planning for elderly inpatients. Preceptor for new nurses and student nurses. Program Development, including program re-design and development of orientation and

continuing education training programs for new employees. Psychosocial Assessments and care planning. Group Psychotherapy and Cognitive Therapy with non-acute patients.

Philadelphia Psychiatric Center, Philadelphia, PA Jan 1989 to June 1989, Staff RN with Charge Nurse Duties

Responsibilities: Chronic Medical Care and Acute Psychiatric Care of Geriatric Patients on a specialized unit

designed both the chronic medical and psychiatric needs of patient over age 55.

Hospital of University of Pennsylvania, Philadelphia, PAMay 1988 to Aug 1988, Nursing Assistant

Responsibilities: Vital signs and Basic Care of patients on an inpatient surgical unit, summer position.

New Ralston House, Philadelphia, PAMay 1987 to May 1988, Nursing Assistant

Responsibilities: Vital signs and Basic Care of patients in a skilled nursing facility, summer and on-call school year

position.

Western Reserve Convalescent Home, Chesterland, OH

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Page 4: Renee Reber Resume2 Sept2015

Renee Reber, RN, MSN, CIP 847-927-5349 [email protected]

May 1986 to January 1987, Nursing AssistantResponsibilities:

Vital signs and Basic Care of patients in a skilled nursing facility, summer and winter break position

EducationUniversity of Pittsburgh, Pittsburgh, PA — 1990 to 1992Masters of Science Nursing, Psychiatric and Education SpecializationThesis: Overmedication with Psychotropics: Preventive Education for Gero-Psychiatric Nurses & Assistants

University of Pennsylvania, Philadelphia, PA — 1985-1988 Bachelor of Science in Nursing

Licensure, Certification, & Professional Affiliation• Registered Nurse, State of Illinois: RN No. 041309402• Certified IRB Professional (CIP), Council for Certification of IRB Professionals, December 2005 to present• Member, Public Responsibility in Medicine and Research (PRIM&R)• Member, Sigma Theta Tau Nursing Society

Volunteer Activities• Summer Camp Nurse, YMCA Camp Echo – 2012 to present

References are available upon request.

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