Clinical Research Associate

Marlton, NJ
Full Time
Experienced
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; Beijing, China and Montevideo, Uruguay.  
 
There are 64 million patients struggling with Heart Failure worldwide.  When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope.  The only options down the road are extremely invasive.  CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. 
 
This is not a job; it is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy.  This requires a team of the best medical device and therapy awareness representatives in the world to educate the cardiology community. 

The Clinical Research Associate will be assigned to support one or more Clinical Trial Manager(s) (CTM) responsible for the management of all aspects of the clinical study team (CST) activities for the assigned clinical trial(s). The CRA will be responsible for the coordination and management of all administrative, regulatory, and site management aspects of clinical trial(s) they are assigned to.

 

How You Will Add Value:

  • · Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, electronic or binder preparation for distribution.
  • · Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review
  • · Prepare CST meeting minutes.
  • · Act as a resource for the clinical sites and research monitors for the trial.
  • · Assist with training of site staff who are working on the study.
  • · Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records.
  • · Review various study-related tracking systems to determine and report status of clinical trial documents.
  • Collect outstanding documents by contacting the clinical trial sites or working with the field monitors.
  • · Send notifications to the clinical trial sites regarding their IRB renewal dates.
  • · Maintain and audit all study related files in compliance with department standard operating procedures.
  • · Assist with the follow-up and resolution of noted observations on audit and monitoring reports.
  • · Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories.
  • · Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies.
  • · Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings.
  • · Review and approve Site Qualification Reports for new clinical trial sites · Train users on the EDC/case report forms and other systems that may be used (i.e., electronic regulatory Binders).
  • · Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment.
 

What You are Bringing With You:

  • · Bachelor’s degree in life sciences or related field preferred.
  • · 1-2 years clinical research experience with bachelor’s degree or
  • · 4 years clinical research experience with professional certification (CCRP, ACRP)
  • · Experience with communicating with hospital administrators, research nurses and study coordinators.
  • · Working knowledge of FDA regulations and Good Clinical Practices.
  • · Experience with IBM eCRFs, ClinPlus CTMS, and Florence or other electronic data and/or regulatory solutions.
  • · Medical device clinical trials experience


 

Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.


 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.
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