Vanessa Brown, CRC, CRA and SR. Regulatory Coordinator

**** *. ******** ***., *******, Illinois 60660

Cell: 773-***-****

Phone: 773-***-****

acg7sg@r.postjobfree.com

Objective: To enhance and facilitate the administration of clinical research

trials and Ensure Compliance

Professional Highlights

03/08-Present

Advocate Christ Medical Center/ Department of Medicine/ Oncology/ Research &

Innovation

Senior Regulatory Coordinator for over 100 Oncology Trials

Maintain GCP’s, ICH, and FDA Regulations

Senior Regulatory Coordinator covering over 100+ Oncology Trials

Maintained operational procedures of Clinical Trials for IRB

Coordinates the registration, enrollment, record keeping and data compilation

and maintaining records for Protocol Patients

Collect and process physician agreements/contracts

Prepares and submits required reports regarding trial progress, SAE reports,

Protocol status change updates, termination reports to the IRB and other

Regulatory committees as per their guidelines

Review protocols

Member of the Research Team to the planning and implementation of new

protocols

Analyze the order of submission to the IRB

Closing out studies

Keeping the Research Team aware of the progress of new protocols throughout

The IRB process

Ensures regulatory process is followed as designated in the cooperative trials by

laws as well as outlined in the procedures related to the Institutional IRB

Process submission of newly posted amendments, adverse events reports and

study updated

Regulatory Binders are well organized and complete

Coordinates follow-up and maintenance for protocol patients and studies

Attends continuing education programs to attain or meet certification

Requirements

Keeping informed of clinical research, institutional and IRB changes

Supplies Primary Investigator and Sub-Investigators, Institutional Review Board,

Director of Medicine and Manager, Office of Clinical Research with current

Information relating to Research Protocol activities

Key Liaison between the IRB, protocol sponsors, investigators and staff

Keeping investigators and staff apprised of protocol updates and adverse events

posted to the websites and any changes or requirements that may need to be

addressed such as re-consenting or protocol hold which develop

Maintains good working relationship with the IRB, communication and

collaboration with the industry sponsors representative

Developed System Wide SOP’s for department of research

Maintain Physician License and CV’s updates

05/07-02/08

ICON Pharmaceutical Clinical Research /Smith Hanley Consulting Group

LLC In House CRA/Project Associate

CRA covering one hundred sites for Clinical Registry Trials/Crohn’s Disease

Make direct contact with Study Coordinators and Primary Investigators/Training

Sites

Enter and Track Data obtained from sites in ICON’s tracking system

Collect and process essential/regulatory documents

Collect and process physician agreements/contracts

Train sites on protocol and case report forms completion

Assist sites with query resolution

Assist sites with questions and documentation when needed via telephone,

email, or fax

Process SAE’s in a timely manner

11/05-05/07

Radiant Research/Chicago

Clinical Research Coordinator

Primary Coordinator of Phase I,II,III, and IV clinical trials and co-coordinator of

clinical trials in all therapeutic areas.

Maintain GCP’s, ICH, and FDA Regulations

Proficient in data management

Committed to quality patient care

Completion and documentation of CRF’s and Source Documents with Accuracy

Drug dispensing and accountability

Perform and adhere to protocol procedures

Administer the consent process

Maintain intra-study regulatory documents

Monitor patient’s condition and assess for AE’s with follow-up

Conduct monitoring visits

Review protocols

Current Clinical Research Experience:

A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of XXXX

Versus Placebo in Subjects with Primary Hypercholesterolemia.

A Multicenter, Randomized, Double Blind, Phase III Study of the Comparative

Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines

(XXXX and XXXX).

A Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety,

Tolerability and Efficacy of XXXX Alone or Co-Administered with Atorvastatin in

Patients with Primary Dyslipidemia.

A validation study of the COPD-PS in a common-based sample.

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the

Safety and Efficacy of XXXX and XXXX Combination Therapy to XXXX and

XXXX Monotherapy in Subjects with Mixed Dyslipidemia.

A Long-Term, Open-Label, Safety Extension Study of the Combination of XXXX

and Statin Therapy for Subjects with Mixed Dyslipidemia.

A Open-Label Extension Study to Evaluate the Safety and Tolerability of XXXX in

Subjects with Primary Hypercholesterolemia or Combined Hyperlipidemia.

A Phase II, Double Blind, Randomized, Placebo-controlled, Parallel Group Study,

Evaluating the Efficacy and Safety of XXXX over a 24-week period in Patients

with CHD or a CHD Risk Equivalent.

A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design

Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment with XXXX

QD dose or XXXX QD doses or a Combination of One of the Doses of Each

Medication.

04/04-11/05

Innovative Alternatives/Abbott Laboratory’s

Clinical Documentation Specialist

Track receipt and entry of CRF’s in tracking database, preparation of documents

for E-submission.

Data entry of CRF’s in database

01/04-11/04

Paramedical Examiner/Portamedic

Independent Contractor for Insurance Companies

Perform paramedical examinations and other health services in a timely and

professional manner.

10/02-12/03

Northwestern Memorial Physicians Group

Clinical Research Coordinator

Primary Coordinator of Phase I, II, III, and IV clinical trials and co-coordinator of

clinical trials in the therapeutic arrears of pain management, dermatology, women’s

health, diabetes mellitus, hypertension, osteoarthritis, rheumatoid arthritis, HIV-

RNA and Genotyping HIV.

Received numerous accommodations for professional expertise in source

documentation and CRF accuracy and completion.

Maintain GCP’s, ICH, and FDA regulations

Assisted with unit-based QA programs and generated queries for review and

resolution

Assist in the creation of cleaning of clinical study database

Assist in data entry for Study Manger

Facilitator of Patient Orientation Program for potential clinical trials subjects

Coordinate all clinical research related activities

Proficient in data management

Proficient in recruitment and enrollment

Committed to quality patient care

Completion and documentation of CRF’s and Source Documents with accuracy

Drug dispensing and accountability

Perform and adhere to protocol procedures

Administer the consent process

Maintain intra-study regulatory documents

Monitor patient’s condition and assess for AE’s with follow-up

Perform patient education as it relates to patient compliance, study drug, and

scheduled activities

Coordinate scheduled activities with related ancillary departments

Initate and conduct meetings for site qualification, initation, and monitoring

visits

Create marketing strategies to enhance and meet enrollment goals

Responsible for the training and ongoing development of new study

coordinators, research assistant, LPN’s and RN’s

Review protocol and create source documents

6/99-09/02

Northwestern Center For Clinical Research

Clinical Research Coordinator

Coordinated clinical trials in rheumatology, gastroenterology, endocrinology,

respiratory, urology, psychiatry, and medical device study

10/96-05/99

Rush-Presbyterian St.-Luke Medical Center

Clinical Research Coordinator

Coordinated clinical trials in rheumatology. Managed 20-30 trials

01/80-09/96

Rush-Presbyterian St.Lukes Medical Center

Phlebotomist/Liaison Technician

Responsible for specimen collection and processing

Executed and maintained appropriate documentation

Education/Certifications/Licenses

Business Administration Degree/Illinois Medical Collage/Associate’s Degree

(AA/AS/AAS), April 1980

Certified Medical Assistant / Certificate/License of Phlebotomist-License

Number: 0491Y84/EKG Technician

Certificate of Training and Development for Clinical Research Coordinator Skills-

Barnett-6/99

Contact this candidate