Clinical Research Medical Device

Mary Margaret Dyer, RCIS, Senior CRA

**** ******** **** • San Diego, CA 92115

858-***-**** • adglfi@r.postjobfree.com

Profile

Healthcare professional with experience and multiple skill sets in healthcare, the medical device industry, clinical trial monitoring and site management, Field Clinical Engineer with industry start-up medical device training, education and sales support

Able to quickly learn new protocols and medical devices

Proctor physicians and ancillary staff on new protocols and medical devices under investigation

Responsible, disciplined, home based CRA having traveled to sites in the US, EU and Canada for presentations, clinical trial site initiation and start up and close out, and device training and implants

Experienced in developing and maintaining the clinical, technical and administrative aspects of clinical research in phase I-IV clinical trials in a challenging research environment

Capable of maintaining composure and a high degree of professionalism, while providing clinical, technical, and educational support to assist in achieving overall company goals

Excellent managing communications with clinical trial sites and Investigators to ensure problem resolution/follow-up and foster customer loyalty and satisfaction. Excellent communication, presentation and documentation skills

Experienced working with device engineers and R/D to provide feedback from the field on product performance and the progress of clinical trials

Ability to travel extensively, self starter who maintains a high degree of ethical, moral, and personal values in decisions, communications, and actions

PROFESSIONAL EXPERIENCE

Dexcom January 2020- March 2020 Furloughed due to Pandemic

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. Dexcom is currently testing its next generation of blood glucose monitoring systems.

Clinical Research Associate

Duties include:

Provide clinical study support services at clinical sites (physician’s office, clinical research facility or hospital research site), including, but not limited to, the below tasks

Review study execution/protocol compliance and enter findings into “Floor Check Worksheet” every hour

Confirm source documentation done per ALCOAC (data being documented at real time)

Escalate any issues (i.e., PDs, AEs, SAEs) to Dexcom Lead CRA

Review completeness of Device Issue Reporting

QC the data connection status and downloads from every Dexcom device

QC the downloads from every SMBG meter

Responsible for drafting and obtaining approval from Dexcom Site Lead and Management on an interim monitoring report (or abbreviated report as applicable) every week.

Ensure site re-training is conducted (as needed throughout the study)

Review supplies with site to ensure adequate amounts present for study

Administrative: Complete assignment administrative tasks and participate in study-related team meetings, including, but not limited to, the below:

Submit a daily CRA report

Attend Weekly Study/Site Progress Conference Call

Escalate questions from the site or self within 24-hours

Modus Consulting Inc. San Diego California June 2017- December 2019

Modus Consulting is a boutique consulting firm catering to large manufacturing companies who need forecasting, development and software implementation with ERP systems installment and configuration. The company's focus is helping clients use tools to control, manage and synchronize their supply chain.

Administrative assistant and account manager

Duties included:

Run Excel analysis

Preform financial research

Prepare reports and documents for clients

Maintain project management software

Maintain company task lists for each project to ensure customer satisfaction

Present company during sales presentation to demonstrate what Modus can do for a new company

Help to support new companies as they on board with Modus

Novella Clinical Morrisville, North Carolina March 2015-May 2017

Novella is a Specialty Medical Device CRO that concentrates on the unique needs of medical device and diagnostics companies, guiding them from regulatory assessments to post-marketing strategies.

Senior CRA

Duties included

Managed 24 clinical research sites. Duties included working with the Principal investigator during implant to managing the research staff at each site to ensure proper adherence to the protocol. Monitor research sites while providing clinical, technical, and educational support to assist in achieving overall company goals

Oversee the progress of assigned clinical trials to ensure that the clinical protocol, Federal Regulations, policies, procedures, and guidelines are followed, data integrity is maintained, and project timelines are met.

Train and proctor physicians and site personnel on clinical protocol and investigational responsibilities prior to and during implant of investigational device or prior to investigational drug delivery

Perform site initiation visits to prepare new clinical sites on medical device under investigation.

Make recommendations to Regulatory Affairs when clinical study compliance is not adhered to and corrective action and/or FDA notification is required

Collect and provide physician feedback for the device sponsor on product performance

Work with regulatory to provide create study documents and source documents to assist sites with data collection and oversee the timely IRB approval of trial amendments.

Flowonix Medical INC. Mt Olive, New Jersey December 2007-July 2014

Flowonix Medical Incorporated is a start-up medical device company providing proprietary implantable pumps that are capable of delivering a wide array of therapeutic drugs for the treatment of chronic diseases and conditions.

Senior CRA/Field engineer

Monitor and supervise the monitoring of clinical data and/or compliance data for assigned clinical trials

Oversee the progress of assigned clinical trials to ensure that the clinical protocol, Federal Regulations, policies, procedures, and guidelines are followed, data integrity is maintained, and project timelines are met

Train appropriate site personnel on clinical protocol and investigational responsibilities at the study site or in-house. Be on site for implants to ensure the PI is following the instructions for use.

Make recommendations to Regulatory Affairs when clinical study compliance is not adhered to and corrective action and/or FDA notification is required

Travel to research sites in Europe and the US to educate, proctor and support clinical research staff on the proper use of company product

Contribute to investigator and field conference calls to ensure clinical trial information is shared and study site personnel remain current on the progress of the clinical trial

Coordinate communication between internal and external customers to maintain adequate trial inventory and facilitate return of product according to departmental SOP

Act as an expert to in-house and study site personnel regarding the product under testing and the clinical trial conduct

Attend investigator meetings, and trade shows to interact with potential new investigators on the clinical program and the investigational device

Accomplishments

Helped start a 7-center clinical trial in the US. Together with the entire clinical team completed a successful US PMA submission to the FDA in 2012 and successful CE mark in Europe in 2010.

XTENT, Inc. Menlo Park, CA March 2007 –November Company Closed

XTENT Inc. was a medical device startup company based in Silicon Valley who developed a drug eluting stent platform that could customize both stent lengths and diameters in the artery.

Senior CRA

Travel to research sites in Europe and the US to educate, proctor and support cardiologists, clinicians, and hospital and research staff on the proper use of company product

Train appropriate site personnel on clinical protocol and investigational responsibilities at the study site or in-house

Provide support and act as a resource to sites to enable them to become self-sufficient with patient enrollment and device implantation

Oversee the progress of assigned clinical trials to ensure that the clinical protocol, Federal Regulations, policies, procedures, and guidelines are followed, data integrity is maintained, and project timelines are met

Make recommendations to Regulatory Affairs when clinical study compliance is not adhered to and corrective action and/or FDA notification is required

Act as a resource to engineering by providing clinical and technical input into the development of new devices and serve as the clinical representative on project teams.

Participate in writing and reviewing device Instructions for Use (IFU)

Act as project expert to in-house and study site personnel regarding the product under test and the clinical trial conduct

Attend case studies, investigator meetings, and trade shows for interaction with investigators to better understand product performance

Contribute to investigator and field conference calls to ensure clinical trial information is shared and study site personnel remain current on the progress of the clinical trial

Screen potential investigators by site visits, profiles, and historical performance

Coordinate communication between internal and external customers to maintain adequate trial inventory and facilitate return of product according to departmental SOP’s

Monitor and supervise the monitoring of clinical data and/or compliance data for assigned clinical trials

Accomplishments

Helped start a 13-center clinical trial in France, Belgium, Germany, and the Netherlands. Together with the clinical team complied data from European trials for a US IDE submission to the FDA. Screened over 100 sites for a US IDE trial.

Terumo Cardiovascular Systems, Inc. Tustin, CA 11/04 – 03/07

Terumo is a medical device company focused on developing, manufacturing and selling superior products for cardiac surgery, cardiology, transfusion, general hospital supply, and home health care.

Senior Clinical Specialist

Support and proctor cardiologists, neurologists, Nurses, Technologists, and research staff on the proper use of Terumo Products

Under sales and marketing division support sales and marketing for the US and Canada.

Travel to system installation sites to in-service and train investigators and clinicians in hospitals, clinics, and private offices

Work with sales to build strong and lasting relationships for the company by providing high level of service and support

Lead training with clinicians to integrate product into their existing routine/practice

Professionally represent the company and demonstrate features/benefits/clinical applications at meetings, trade shows and other educational opportunities

Work with sales reps/territory managers to resolve issues and communicate customer feedback and product development needs to marketing and product management

Provide support in clinical evaluations of new products/technologies

Read and summarize medical journal articles relating to our business

Maintain a sales focus during product in-services to showcase product benefits

Accomplishments

Helped start a new division within Terumo for a Transcranial Doppler instrument used in cardiology and neurology applications. Together with sales and marketing built a highly competitive and sought-after product line in less than two years.

Created training tools and support services from the ground up for our new and growing customer base

Used my background in clinical research to support Terumo’s alliance with AGA and St Jude Medical for two IDE clinical trials

Received “excellent” on all evaluations

Promoted to Senior Clinical Specialist

Scripps Hospital and Research Foundation La Jolla, CA September 1999-Junary 2005

An internationally recognized healthcare facility with 173 acute care beds and extensive research and specialty services.

Interventional Cardiology Clinical Research Coordinator-CCRC

Developed, maintained and supported the clinical, technical and administrative aspects of clinical research in phase I-IV trials.

Initiated, coordinated and monitored investigator initiated trials

Assisted in developing new protocols, case report forms, consents, instructions for use, study budgets and contracts.

In serviced investigators, coordinators and cath lab staff on device systems and protocols

Assisted data management group with review of clinical data/information and oversight of data correction.

Ensured compliance with all FDA, GCP and ICH guidelines

Drafted continuous quality improvement processes for interventional cardiology research team

Prepared for and successfully completed two FDA audits

Trained and managed coordinators and research assistants

Assign monitors and coordinators based on project needs

Track monitoring schedules and review monitor reports

Accomplishments

After spending over a year in the cardiac cath lab I was invited to join the interventional cardiology research team. I was promoted and immediately assumed responsibility for 3 large IDE trials with over 200 subjects enrolled that had been without a research coordinator for several months. The site was behind in patient follow up and regulatory submissions and had not been monitored in almost a year. Within 3 months of my start date:

All patient follow up was completed bringing the studies into compliance.

All CRFs were monitored and data submitted.

All regulatory submissions were made to the IRB/FDA.

Protocol deviations were reduced by more than 50%.

Additional responsibilities outside of primary research assignment included the following:

Utilizing my experience and skills to assist physicians in the cardiac cath Lab and OR during procedures:

PTCA

Stents

Rotoblator

IABP insertion

Pulmonary Stents

Coils

Peripheral and congenital procedures

Thrombolysis procedures (Angiojet, Percusurge)

Pacemaker insertion and electrophysiology

Assisting other departments with recruitment and enrollment strategies

Planning and coordinating investigator meetings

Assisting other departments in preparing for FDA audits

Texas Children’s Hospital Houston, TX 03/96 – 03/98

One of the largest and highest rated full care pediatric hospitals in the world.

Registered Cardiovascular Invasive Specialist/Research Assistant

Worked with physicians to diagnose, treat, and research congenital cardiovascular disease. Duties included assisting with:

Pulmonary Stents

Coils

Peripheral and congenital diagnostic procedures

Cardiac biopsies

Pacemaker insertions and Electrophysiology

Providing clinical study and administrative support to research coordinator

Maintaining and tracking of research equipment and study-related supplies

Ordering and maintaining cath lab inventory

Assisting with preparation and submission of materials needed by the Institutional Review Board and other regulatory bodies

Preparing reports for study investigators on recruitment efforts and status of data collection

Setting up and maintaining confidential study files and site binders

Supporting all aspects of clinical research from start-up to education and training of hospital staff, through execution of protocol and study closeout

Memorial Hermann Healthcare System Houston, TX 07/93 – 01/96

A system of 12 hospitals throughout Houston affiliated with Baylor University School of Medicine.

Registered Cardiovascular Technologist II/Team Leader

Assists physicians in diagnosing and treating cardiac and peripheral vascular disease in an invasive procedure arena, specializing in the care of patients undergoing:

PTCA

Stents

IABP insertion

Peripheral and diagnostic and interventional procedures

Thrombolysis procedures

Pacemaker insertion and electrophysiology

Hemodynamic Monitoring

Texas Heart Institute of St Luke’s Hospital Houston, TX 07/92 – 07/93

The Texas Heart Institute is a non profit organization dedicated to research and prevention of cardiovascular diseases. Affiliated with St Luke’s Episcopal Hospital a teaching facility ranked in the top ten in the US.

Registered Cardiovascular Technologist

Recruited directly out of college, I accepted a 1 year paid internship in the cardiac catheterization laboratory.

CERTIFICATIONS

Society of Invasive Cardiovascular Professionals: RCIS

Association of Clinical Research Professionals: CCRC

ACLS/BCLS

EDUCATION

5/92 Grossmont College San Diego, CA

Associate Degree in Cardiovascular Technology

PROFESSIONAL AFFILIATIONS

Association of Clinical Research Professionals

Society of Invasive Cardiovascular Specialists

American Heart Association

American Institute of Ultrasound in Medicine

REFERNCES

Professional and personal references available upon request

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