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Clinical Research Training

Location:
Sarasota, FL, 34238
Salary:
62000.00
Posted:
August 14, 2012

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Resume:

JANICE SPECTOR, CRA

**** ********** ****** ********, ******* 34238 Tel. 941-***-**** ux574t@r.postjobfree.com

OBJECTIVE

Clinical Research Associate

PROFILE

Self- motivated and goal focused with track record of completing projects in a timely manner

Ability to assimilate protocols, monitoring plans and regulatory compliance requirements quickly

Highly productive, detail oriented and result driven

Adapt easily to new responsibilities

Proven ability to work productively in high-pressure situations.

Innovative problem solver with excellent interpersonal and communication skills

Organized with excellent time management skills and the ability to make evaluative judgments in high pressure situations

Enthusiastic team player

Therapeutic areas of Expertise:

Oncology: (Prostate, Bladder, Melanoma)

Cardiology: Hypertension, Atrial Fibrillation, Diabetes

Urology: Benign Prostatic Hyperplasia, Overactive Bladder, Neurogenic Detrusor Overactive Bladder, High Grade PIN

RELEVANT SKILLS

Site selection, screening, initiation, monitoring and closeout

Development of source document notebooks and study initiation deliverables (Research Site Evaluation Form, checklist for Site Initiation, Monitoring Visit, and Site closeout)

Validation of inclusion/exclusion criteria for potential participants and Review of Informed Consent forms (ICs)

Review of site study files for completeness, accuracy and IRB related documents

Review of CRFs for completeness, clarity, legibility, consistency, conformity to available source documentation, and adherence to protocol requirements, SOPs, and GCP guidelines

Identification of deficiencies and discrepancies

Ensuring timely CRF query resolution through remedial corrective action as required per SOPs, Protocol, ICH/GCP guidelines and regulations

Evaluation of subject enrolment; Compilation and review patients’ status tracking information.

Reporting of adverse events and SAEs

Management of study supplies inventory (IND, CRFs, samples for QA & lab kits)

Serve as a resource for and interact with other functional areas to resolve project issues and facilitate project timelines

EMPLOYMENT HISTORY

Clinical Research Coordinator

Florida Urology Specialist – Sarasota, Florida 2007 to Present

Developed a successful Clinical Research Department for a Sarasota, Florida

urological practice .

Supervised and evaluated research staff including Administrative Assistants,

Research Coordinators.

Developed and maintained staff education.

Coordinated over 50 phase II and III IV pharmaceutical and device clinical

research trials.

I am a liaison between Investigator, Research Coordinators and ancillary services.

Directed all Financial/Budgetary components of the clinical research

department including preparation of the clinical trial budgets, determination of

anticipated study-related costs and profit margins, negotiation of fees for

associated services (e.g. laboratory, radiology, study-specific advertising),

reviewed contracts and letters of indemnification for completeness.

Wrote and implemented clinical research SOPs as required by the CFR (Codes of

Federal Regulation).

Clinical Research Coordinator

Cardiovascular Center of Sarasota - Sarasota, Florida 2006 - 2007

• Collect and review essential regulatory documents to ensure site compliance with GCP, Protocol and company SOPs

• Perform Source Data Verification and Review of CRFs for safety issues, patterns, complete-ness and quality as per SOPs and GCP guidelines and report any problems/concerns to appropriate clinical manager; Paper and electronic CRF data entry and data analysis.

• Review of site study files for completeness accuracy and IRB related documents.

• Management of site study supplies (IND, CRFs, lab kits and shipping supplies).

• Identifications of deficiencies and discrepancies.

Clinical Research Associate

KRC, Inc. (CRO) – North York, ON 2005 – 2006

• Ensure all study monitoring duties are accomplished in adherence to clinical study timelines.

• Establish and maintain excellent rapport with all stakeholders to ensure the execution of clinical trials in a timely, efficient and effective manner

• Collect and review essential regulatory documents to ensure site compliance with GCP, Protocol and company SOPs

• Perform Source Data Verification and Review of CRFs for safety issues, patterns, complete-ness and quality as per SOPs and GCP guidelines and report any problems/concerns to appropriate clinical manager; Paper and electronic CRF data entry and data analysis.

Clinical Medical Assistant 1989 – 2003

WHOLISTIC HEALTH CLINIC – Sarasota, FL

• Responsible for all aspects of the office management

• Designed and developed various logs and tracking systems

• Assisted with patient modalities and participated in development of patient treatment plans/programs.

EDUCATION

Bachelor of Arts Southern Illinois University, Carbondale, IL 1980

Training Courses & Seminars:

Clinical Research Associate Diploma Kriger Research Center, Inc., Toronto, ON

Clinical Research Monitoring Fundamentals 2005

Systematic Monitoring Approach to Effectively Monitor a Multi-Center Trial, KRGI Inc.

SAE Reporting, KRGI Inc.

ICH GCP Guidelines (E6, E2), KRGI Inc.

Certified in Blood Pressures: Shared Care Research & Education Corp

2006

Norton Audits: Corrective and Preventative Actions or CAPA

2007

Norton audits: Clinical Operations Introduction to Standard Operating Procedures

2007

ACRP: “Ethic in Medicine and Research” & “tales for the Auditing Crypt”

2007

Norton Audits: Conducting Clinical Investigator Qualification Visits

2008

ACRP: Webinar: “Taking a New Approach to Monitoring”

2011

7th Annual Cardiovascular Symposium: Update 2011: From Intervention to Prevention

2011

AUA : Annual Meeting: 2008, 2009, 2010, 2011, 2012

ACRP: member: 2010, 2011, 2012

ICAO/IATA Certification-for the shipping of hazardous materials, by air, domestically and internationally

Clinical Research Associate Program Norton Training Institute 2012

A Service of Norton Audits, Inc.

• NT21: Conducting A Clinical Investigator Qualification Visit

• NT22: Essential Regulatory Documents

• NT23: Introduction to Clinical Research Monitoring

• NT24: Legal Training for Determining Qualifications of Clinical Investigators

• NT25: Norton Method: Auditing Skills for Monitors

• NT26: Reporting of Pre-Marketing Adverse Events

• NT27: Sensitivity to Clinical Research Fraud and Misconduct

• NT51: Clinical Operations Introduction to Standard Operating Procedures

• NT52: Clinical Operations GCP and ICH Training Series: Advertising for Study Subject Recruitment

• NT53: Clinical Operations GCP and ICH Training Series: Clinical Research Personnel C.V.'s & Licenses

• NT54: Clinical Operations GCP and ICH Training Series: Completing and Maintaining Case Report Forms

• NT55: Clinical Operations GCP and ICH Training Series: Completion of Form FDA 1572

• NT56: Clinical Operations GCP and ICH Training Series: Confidentiality of Clinical Trial Information

• NT57: Clinical Operations GCP and ICH Training Series: Corrective and Preventative Actions Procedures

• NT58: Clinical Operations GCP and ICH Training Series: Documenting Delegation of Authority

• NT59: Clinical Operations GCP and ICH Training Series: Interim Monitoring Visits

• NT60: Clinical Operations GCP and ICH Training Series: Monitoring Close-Out Visits

• NT61: Clinical Operations GCP and ICH Training Series: On Call or Off Hours Procedures

CLINICAL COMPUTER PROGRAMS

Phase Forward InForm 4.5. 4.6 5.0 Kronos Comm. Health Decisions Datatrac

Trifecta Perceptive

Invivodata System Impala

Oracle RDC Rave

Cenduit Fisher Acts



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