Training Project

Helen Dinan ? *** Shirley Rd ? Bellingham, MA ****9 ? 781-***-****

? *******@*****.***

Relevant Professional Experience:

Senior Clinical Trial Coordinator (inVentiv Health contractor)

Biogen Idec, Cambridge, MA February 2013-

Present

> Coordinating study critical meetings (e.g. SMT meetings)

> Supporting audit/inspection readiness

> Collecting, reviewing and tracking of essential regulatory documents

> Coordinating CDA preparation, collection and execution

> Setting up, updating and maintaining the clinical trial management

system

> Collecting 1572s and CVs of principal investigators

> Tracking of all monitoring visit reports provided by the CRO

> Obtaining Clinical Trial Insurance

> Being a knowledge resource for other Clinical Trial Coordinators

> Ad hoc tasks as assigned by i3 Site Manager

Clinical Trial Specialist

Boston Scientific Corporation, Marlborough, MA August 2011-

February 2013

> Processed all regulatory documents for two separate clinical trials,

including uploading to electronic repository and filing hard copies in

the Trial Master File in accordance with GCP and corporate SOPs

> Ensured file integrity for FDA audit readiness

> Distributed project specific training to applicable project team

members and tracked overall training compliance

> Owner of the Master User List (MUL) for two separate trials, updating

site and internal user access to the Electronic Data Capture System

(EDC)

> Generated study materials and coordinated distribution to the sites

> Managed email distribution lists and updated as necessary

> Performed site file reviews in order to prepare for both internal and

external audits

> Maintained study team rosters as well as site contact lists, updating

as required

> Assisted in-house Clinical Research Associates in study start-up

activities, including but not limited to assembling and distributing

the Investigator Site File (ISF) and Manual of Operations (MOP)

> Generated and distributed protocol training certificates to site

personnel upon training completion

> Shadowed CRAs when contract negotiations and ICF reviews were

occurring

> Assisted with training of new employees and contractors

> Complied with all training requirements and deadlines

Clinical Trial Disclosure Associate (Kaztronix, LLC contractor)

Genzyme Corporation, Cambridge, MA November 2010-

August 2011

> Subject Matter Expert for creating Protocol Registration submissions

for ClinicalTrials.gov

> Reviewed submissions for accuracy and completeness according to NIH

policy and formatting requirements

> Analyzed U.S and international regulations to ensure that all protocol

registrations were in compliance

> Subject Matter Expert for Protocol Registrations on international

websites including Australia, Netherlands, UK, and India

> Maintained compliance with the frequently changing international

regulations while posting across multi-national registries

> Collaborated with cross-functional team members around the globe in

order to ensure that protocol records were accurate and in compliance

with federal and international regulations

> Created and maintained trackers to ensure that all protocols were

registered and updated within the required timelines.

> Contributed to Clinical Trial Transparency SOP and WI development

> Supported New System Implementation, including but not limited to

participating in User Acceptance Testing

Clinical Trial Coordinator

Boston Scientific Corporation, Marlborough, MA June

2008-May 2010

> Took meeting minutes for two weekly project team meetings and

distributed to team members

> Processed and tracked payments for study sites, vendors, and

contractors on a timely basis

> Filed and tracked documentation in accordance with FDA regulations,

GCP and corporate SOPs

> Ensured file integrity for FDA audit readiness

> Distributed documents to sites and sent out mass mailings as needed

> Maintained study team and site contact lists and updated/distributed

as necessary

> Owner of the MUL (Master User List) for four separate trials, updating

user access to the databases

> Tracked Clinical Study Agreements (CSAs) and ensured appropriate

signatures were obtained

> Submitted Change Requests through the Product Data Management system

(PDM) when documents needed to be revised or new documents were being

added

> Complied with all training requirements and deadlines

Clinical Research Coordinator

Genzyme Corporation, Cambridge, MA January 2008-June

2008 (contract position)

> Assisted in the collection, logging, filing and tracking of clinical

study documentation in accordance with FDA regulations, GCP and

company standard operating policies and procedures.

> Established and maintained study files

> Assisted with planning and preparation for internal and off-site

meetings

> Initiated and tracked payments to clinical study sites, study

patients, contract laboratories, contract personnel and other vendors.

> Ensured the completion of routine administrative duties such as

arranging meetings and/or conferences, recording meeting minutes,

document distribution and mass mailings

> Provided assistance to project team CRAs in coordination of clinical

supply shipments, and setting up investigators/coordinators meetings

as needed

Patient Service Coordinator II/OR Scheduler (Department of Urology)

Tufts Medical Center, Boston, MA August

2006-November 2007

> Fielded all incoming phone calls for three physicians and registered

nurse.

> Scheduled all appointments and diagnostic testing such as blood work,

CT Scans, MRIs and biopsies

> Scheduled surgeries, which included booking the necessary surgical

equipment

> Coordinated preoperative appointments and anesthesia

> Formatted and sent out letters to patients for appointment reminders

and pre-operation/surgical instructions

> Checked patients in and out for office visits

> Collected and logged all insurance co-payments

> Entered requisitions into the computer system

> Trained volunteers and new employees

> Updated and filed patient files

> Corresponded with other physicians/departments in order to obtain

medical/cardiac clearance for surgical candidates

Education

Regis College, Weston, MA

BA Psychology May 2003

Northeastern University, Boston, MA

MS Regulatory Affairs - expected graduation date 2014

Technology Skills

Microsoft Office Suite ? Siebel CTMS ? Documentum ? Medidata RAVE EDC ?

ClinicalTrials.gov

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