Project Manager Medical

Location:

Canandaigua, NY, 14580

Posted:

August 15, 2013

Contact this candidate

Resume:

Renata Sierzega

* ****** ***** ******

Webster, NY 14580

Mobile 585-***-****

Profile

Comprehensive experience in the clinical research profession since 1996

understanding research methodology, developing, implementing and evaluating

programs. Responsibilities included nationwide coverage as a medical science

liaison, project manager, clinical research associate and clinical trial

manager working in organizations that were both CRO's and sponsors. Diverse

experience with multiple disease processes, prognosis, treatments and

medical terminology in the civilian health care field and as a 30 year

veteran in the Air Force Reserve Nurse Corp.

Career History

From Dec 2010 to Present: 40h/wk Research Health Science

Specialist

Center of Excellence

Veterans Health Administration

Focus on the improvement of health care to veterans as Project Manager of

Meditation for PTSD Demonstration Project which assesses the use of

Complementary and Alternative Medicines (CAM) through defining CAMs,

educating the VHA community, identification of resources utilized,

treatments prescribed and promotion of the use of CAM if appropriate.

Managed the design, plans and conduction of the program. This program is

sponsored by VACO and involves 9 VA facilities.

Therapeutic Area

. Complementary and Alternative Medicines

From Aug 2010 to Present: 15h/wk Bryant and Stratton College

Adjunct Instructor

Adjunct instructor in the Medical Assistant Program. Classes taught include

Medical Terminology and Clinical Procedures including information on

disease process, treatments, and prognosis.

From Aug 2009 to Dec 2010: 40h/wk Senior Clinical Research Associate

Chiltern US

The SCRA will provide expert advice, guidance and general supervision to

Clinical Monitoring team activities for designated projects, and to monitor

specified sites to ensure quality and integrity of data, compliance with

Chiltern International or Client's SOPs, ICH GCP& regulatory requirements

Therapeutic Area/Lab Experience

. Rheumatoid Arthritis

Key areas of Responsibility:

. Site monitoring including Site Qualification, Site Initiation, Monitoring

Visits and Close Out Visits

. Communicate with Chiltern team, sponsor as directed and sites regularly

. Manage trial at the site level including ISF, CSF and others as directed.

. Ensure proper communication and documentation of all study regulatory and

safety issues with the IRB.

. Liaison with data management and study specific vendors as needed and

directed.

. Submit reports and all other required documents as directed on time to

the appropriate person working toward a study that is on time and on

budget.

From August 2007 to July 2009: 40h/wk Senior Clinical

Research Associate

Transave Inc.

Only SCRA for sponsor biotech company acting as the CRA liaison with large

CRO monitoring team ensuring quality monitoring, and ICH GCP compliance.

Therapeutic Area/Lab Experience

. Cystic Fibrosis- Phase 1a/2b for two years US

Key areas of Responsibility:

. Liaison with CRO monitoring team of 4 and supervisory team for a 22 site

nationwide Phase1a/2b clinical trial from site initiation to site closure

. Over site of monitoring responsibilities including ensuring scheduling of

visits, pre and post visit reports review and follow up items.

. Protocol education and co-monitoring activities

. Sponsor representative for site contact.

From February 2007 to May 2007: 40h/wk Clinical Project Manager

Research Dynamics

Clinical project manager working with sponsor for small CRO for in progress

paediatric asthma clinical trial. Supervised rotating team of CRA's

contracted with the CRO, educating on therapeutic area, and ensuring ICH

GCP compliance. Led weekly Sponsor/CRO meetings on trial progress.

Therapeutic Area /Lab Experience

. Paediatric Asthma - Phase 2 & 1 year for this trial, US

Key areas of Responsibility:

Managed North American based Phase 2 trial in paediatric asthma

Managed team consisting of 6 monitors and a Regulatory Document Specialist

Personally audited problem site and took over monitoring assignment

Developed CTMS system database for use in trial

Developed GAP analysis of study

Brought trial in, on time and under budget

Worked closely with EDC provider, spirometry vendor and PK lab throughout

Managed Phase I ID trial

Managing 1 CRA

Managing 1 site

Comprehensive development of initiation visit, interim monitoring and close

out visit reports, monitoring plan, communication plan, weekly sponsor

calls, CRA orientation and education for 6 week long study

From Aug 2006 to February 2007: 40h/wk Clinical Research

Associate III

PPD

Sr CRA responsible for on-site monitoring, verifying data and reporting on

the progress of the trial for 12 clinical sites

Liaison between CRO and investigative site

Therapeutic Area/Lab experience

. Prostate Cancer- Phase III

Key areas of Responsibility

. Over site of monitoring responsibilities including ensuring scheduling of

visits, pre and post visit reports review and follow up items.

. Protocol education and co-monitoring activities

. Site monitoring including Site Qualification, Site Initiation, Monitoring

Visits and Close Out Visits

. Communicate with sponsor team, sponsor as directed and sites regularly to

ensure good ICH GCP

. Manage trial at the site level including ISF, CSF and others as directed.

. Ensure proper communication and documentation of all study regulatory and

safety issues with the IRB.

. Ensure all clinical trial materials and IP are ordered, sent and arrive

on site. Additionally, follow up ensuring adequate supplies throughout

the study.

. Liaison with data management and study specific vendors as needed and

directed.

. Submit reports and all other required documents as directed on time to

the appropriate person working toward a study that is on time and on

budget.

From Aug 2003 to August 2005: 40h/wk Genentech

Medical Science Liaison

Liaison with Key Opinion Leaders in the Cystic Fibrosis community

nationwide conducting off label research on Pulmozyme

Therapeutic Area/Lab Experience

Cystic Fibrosis off label research

Key Areas of Responsibility

. Activated 4 IND research studies

. Initiated over 15 IND research study proposals including use in

transplantation

. Accomplished investigator and site selection and qualification

. Protocol and amendments development

. Reviewed and approved developed consent forms

. Reviewed and coordinated regulatory documents completion and

submission

. Reviewed and approved study budget

. Educated site research team

. Monitored study progression

. Developed key thought leaders nationwide

. Promoted pharmaceutical product through education of disease process

From Jul 1996 to Aug 2003: 40h/wk U of Rochester, Ped Pul

Division

Clinical Research Coordinator

Research Coordinator for a large academic center pediatric pulmonary office

Therapeutic Area/Lab Experience

Cystic Fibrosis/ Asthma

. Coordinated over 15 pharmaceutical sponsored studies in cystic

fibrosis and asthma

. Conducted clinical functions and managed data collection for industry-