Clinical Research Regulatory Compliance

Patricia M. Kaldas

*** *. ****** **., **********, CA. 90640 323-***-**** ********@*****.***

OBJECTIVE

Over 15 + years experience in Clinical Research. Detail-oriented with leadership experience. Dependable and well organized with strong multi-tasking skills. A versatile team player who enjoys assisting others. Strong interpersonal skills. Looking to obtain a position that would offer the ability to grow within the company.

EXPERIENCE

REGULATORY COMPLIANCE MANAGER/SENIOR CLINICAL RESEARCH COORDINATOR

CALIFORNIA NEUROPSYCHOPHARMACOLOGY CLINICAL RESEARCH INSTITUTE-LA, LLC (CNRI-LA, LLC)

JAN. 2007 - PRESENT

Serves as the site regulatory contact for sponsored projects and assists with all site initiation and monitoring visits

Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified

Perform investigation of deviations and monitoring of corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings

Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews

Demonstrate a working knowledge of internal SOP's, FDA/ICH guidelines to GCP's and regulatory compliance

Create, review and revise all functional group SOP's

Provides reporting of all regulatory activities to department leadership

Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process

Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs

Collaborates with departmental staff and faculty to develop and complete necessary documentation for continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports

Coordinate, organize and maintain all documentation required by sponsor or CRO (source documentation, case report forms, study and regulatory binders, and patient binders)

Lead in the coordination of Phase II-IV clinical trials

Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality

Resolve data queries with sponsor and CROs

Recruit, screen and enroll potential study patients as specified per protocol

Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required

Process and ship blood, urine and serum specimens for each trial

Schedule patient visits and any necessary testing

Attend Investigator Initiation Meetings

Create source document forms and maintenance of subject charts

Obtain records required to complete case report forms

Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.

Show vigilance in patient safety, protocol compliance, and data quality.

Cognitive testing on subjects (i.e. Matrics and UPSA).

Perform training for office staff regarding Protocol updates and Inform Consent Form changes

Meet and communicate with study monitors to ensure study compliance and quality control of study procedures

Works with department supervisor/manager to assist and train new hires in the research department

Participate in quality and process improvement efforts to create and maintain a high-performing and efficient team

REGULATORY COMPLIANCE COORDINATOR CALIFORNIA CLINICAL TRIALS NOV. 2005 – DEC. 2006

Regulatory Compliance Coordinator for EDD

Regulatory Compliance for Phase II-IV

Prepare and assist in submission of start-up of new studies, protocol amendments, IND safety reports, consent form changes, and continuing reviews

Demonstrate a working knowledge of internal SOP's, FDA/ICH guidelines to GCP's and regulatory compliance

Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified

Prepare and process all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs)

Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs

Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including initial submissions, continuing reviews, amendments and adverse event reporting.

Resolve regulatory related queries with IRB, study sponsors and CROs

Complete initial submissions as well as biannual submissions to the IRB

Submit and Supervise submissions for start up of new studies

Review of documents (e.g. response documents, study protocols, ICFs)

Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product

TRANSCRIPTIONIST UCLA COUPLES THERAPY PROJECT JAN. 2005 – JUN. 2005

Transcribed marriage counseling tapes for the development of a coding program

Worked with the project manager to discuss and meet transcription timelines

TEACHER UVC, EARLY CARE & EDUCATION JUL. 2004 – SEP. 2004

Assisted in the care and learning for infants and toddlers

HEALTH EDUCATOR INTERN UCLA COMMUNITY OUTREACH PROGRAM (COPE) APR. 2003 – JUN. 2004

Help start pilot program at general hospital's emergency wait rooms

Mentor students between the ages of 5-13 of underprivileged homes

Create teaching techniques and methods to provide effective modules in education for children

EDUCATION

B.A 2005 UNIVERSITY OF CALIFORNIA, LOS ANGELES (UCLA)

Major: Psychology

SKILLS/ ATTRIBUTES

Strong working knowledge of Microsoft Office Suite (Excel, PowerPoint, Word)

Regulatory experience within the biopharmaceutical industry or at a health authority or other relevant experience

Strong project management skills

Leadership skills

Excellent written and verbal communication skills

Ability to analyze problems and recommend actions

Certified Phlebotomist

IATA certified

Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)

Excellent organizational skills and attention to detail in maintaining accurate, retrievable records

Ability to attend to detail and be precise with the ability to work independently, exercising judgment in establishing priorities

Certified in Cognitive testing (UPSA, MATRICS)

Strong knowledge on different eCRF platforms (e.g. Medidata Rave)

LANGUAGES

Fluent in Spanish. (Read and Write)

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