Project Manager Training

Laura Balayan

Clinical Project Coordinator- Children's Oncology Group

Monrovia, CA

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Work Experience

Clinical Project Coordinator

Children's Oncology Group (Non Profit)

Monrovia, CA

• Manage active projects with drug companies.

• Establish routine meetings with industry contacts and or study committee

members.

• Participate in teleconference with industry partners and address minutes/action

items

communicate pertinent information on behalf of the drug company and or study

committee to COG institutions.

• Facilitate the review of protocols, case report forms and remote data entry

screens to ensure that all data collections requirements are met as specified in the signed

agreement and before study and or amendment activation.

• Provide logistical support of clinical trial drug supply coordination.

• Develop drug distribution procedures and establish study drug accountability

procedures.

• Monitor and direct study drug supply/resupply shipments to institutional sites.

• Distribute pharmacy materials to COG institutions such as drug order forms,

accountability logs, and expiration notices.

• Ensure COG supplies all deliverables at time points agreed upon in the contract

and scope of work.

• Monitor agreed upon timelines.

• Participate with onsite visits.

• Provide support to Operations Manger as well as QA Manager in maintaining

COG'S compliance with regulatory responsibilities.

• Responsible for preparing submission for IND-related Filings to the FDA.

Coordinate the collection, scanning, storage, retrieval and delivery of applicable regulatory

documents.

• Attend and participate in trainings, sessions and COG meetings.

• Participate with contracts and execution.

• Participate in the development of budgets and execution.

• Responsible for sending out monthly accrual reports.

• Track and update study progress.

• Implements the quality system procedures and manages compliance.

• Provides guidance for protocol writing.

• Knowledge of ICH, GCP and FDA.

• Participates in implementing SOP's.

PAREXEL International 2007 -- 2012

Clinical Research Coordinator May 2011 – July 2012

Glendale, CA

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• Reviews and understands the study protocol and seeks clarification of any

protocol issues.

• Assesses training needs for the Study Teams and arranges for any additional

training needed for study protocol.

• Orients and trains new Study Team members.

• Provides analysis for study protocol inclusion/exclusion criteria, screening

packets, lab requirements, flow sheets and equipment needs.

• Creates study specific paperwork.

• Prepares staffing requirements with the assistance of the Department Managers

and/or the Nurse Supervisor.

• Trains Study Team members on study rating(s) scale(s) as required and performs

rating scales as needed.

• Supervises study participant enrollment or works with enrollment department

tracking enrollment status to ensure timelines are met.

• Oversees potential study participant scheduling and screening.

• Updates/Maintains ClinCenter and/or visit tickets.

• Signs-off study participant visits.

• Ensures basic study participant safety is provided within the clinic for outpatient

visits and/or hospital for inpatient study periods.

• Communicates with physicians and relevant Clinical Staff in evaluating study

participant status.

• Monitors study participant test results.

• Collects Adverse Events for Pharm.D.

• Ensures all medical equipment (i.e., crash cart, ECG machines, dynamaps, etc.)

is functioning properly.

• Assists in tracking equipment calibration during inpatient study periods at the

hospital.

• Serves as liaison between CCTMG and the hospital for inpatient study periods.

• Remains on-call to handle all after-hours study participant issues.

• Maintains contact with Sponsor and prepares appropriate documentation of such

contact (e.g. letter, progress notes, memos to file.

• Hosts pharmaceutical representative visits.

• Attends outside Investigator meetings as requested (may require travel) and in-

house Investigator meetings.

• Acts as a liaison between Study Team and Quality Management to ensure that

Case Report Forms, source documents and patient charts are properly reviewed.

• Interacts with other Departments in the Company whenever necessary including

Regulatory, Recruiting, Protocol development, Data Management.

• Any other tasks required for successful completion of the study.

• Assists with the creation, review, revision, and/or retirement of Clinical Operating

Guidelines (COGs) as assigned. Upon approval, assists with the training and implementation of

COGs.

• Maintains and updates knowledge of COGs and their proper application.

• All other duties as assigned.

• Acts as a project manager for studies when needed.

Clinical Research Associate

Parexel 2007 -- 2011

Glendale, CA

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• Monitors activities at clinical study site to ensure Good Clinical Practice and

Standard Operation Procedures.

• Review regulatory documents as required and prepare site visit reports.

• Participate in study start up and development of documents (i.e., case report

forms, Informed Consent, monitoring strategy).

• Has detailed knowledge of the study protocols and acceptable performance of

quizzes.

• Ensures basic study participant safety is provided.

• Identifies issues that need Sponsor approval.

• Exhibits professional demeanor at all times in external interactions with

Sponsors/Sponsor Representatives.

• Maintains supportive, flexible manner internally with management,

coworkers/team members.

• Review of clinical documents and templates.

• Prepare and implement project specific training programs and training materials

for internal and external training.

• Collaborate with medical experts, clinical study site and pharmaceutical

company.

• Performs study start -up activities related to monitoring

• Develops and implements innovative approaches for site recruitment, selection

and initiation activities.

• Develops patient enrollment strategies with the project team and clinical trial

sites.

• Conducts interim monitoring visits (conducts source document verification of CRF

against medical records. Ensures the integrity of clinical data and adherence to applicable

regulatory, protocol, and company guidelines.

• Conducts site initiation visits.

• Participates in CRA protocol specific training and development.

• Conducts in-house monitoring activities as needed.

• Review investigator regulatory files to ensure they are accurately maintained.

• Conducts study close out visits.

• Maintains and updates knowledge of Clinical Operating Guidelines and their

proper application.

• Enters study participants in the study participant tracking system, ClinCenter, and

study logs, maintains appointment calendars, and operates company information systems and

computer programs.

• Conducts screening visits, complete study protocol visits, assists staff physicians

in assessment of concomitant medications, adverse events, lab results and other test results.

• Performs appropriate psychometric and efficacy testing according to study

protocol.

• Receives authorized sign-off to verify accuracy of all study participant visits.

• Prepares/monitors study supplies and stock levels in clinic/hospital.

• Labels, inventories and sends plasma samples.

• Problem solves study participant issues as they arise. Attends and assists with

start-up and flowsheet meetings.

• Completes Case Report Forms (CRF) in a timely manner. Reviews and Monitors

CRF.

• Assures quality and accuracy of source and CRF documentation.

• Complies with Quality Management (QM) department guidelines and performs

corrections for QM.

• Follows medical records procedure.

Behavioral Aide/Office Assistant

Hand and Hand Child Development Center Feb 2001 – Aug 2003

Encino, CA

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• Answered phones.

• Ordered supplies.

• Accounting.

• Filed.

• Prepared materials for group sessions and assisting therapist.

Receptionist

Law Offices of Blumberg Feb 1999 – Feb 2001

Van Nuys, CA

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• Answered phones.

• Faxed and copying.

• Translated. (Spanish)

• Accounting.

• Filed and ordered office supplies.

• Opened new files and prepared documents for court.

Education

EKG Technician Certification

California State University of Los Angeles - 2011

Los Angeles, CA

Bachelors in Psychology

California State University of Northridge - 2006

Northridge, CA

Associates Degree

Los Angeles Pierce College - 2003

Woodland Hills, CA

Contact this candidate