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Clinical Trial Assistant

Clinical Trial Assistant
Marlton, NJ

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.

The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines.  Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics.  In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.

The CTA at Impulse Dynamics is a conscientious and detail-oriented person who enjoys making a difference and takes pride in their career to work in our fast-paced office.

How You’ll Add Value
  • Review and process all site invoices. Generate and obtain signatures for Purchase Request Forms, Purchase Orders. Oversee accounts receivable reconciliation.
  • Responsible for purchasing scientific journal articles and uploading them to a central repository.
  • Organize, maintain, and audit department files in compliance with department standard operating procedures.
  • Maintain electronic and hard copy filing systems (CTMS, Egnyte, and Florence).
  • Schedule and coordinate occasional meetings, appointments and travel arrangements for internal and external meetings and personnel.
  • Assist with the preparation of department PowerPoint presentations, meeting minutes and action items tracking.
  • Provide general administrative support including mailing, printing, scanning, shipping and copying.
  • May interact with internal and external contacts regarding clinical trials.
  • Open, sort and distribute incoming correspondence.
  • Run errands to post office and office supply stores, as needed.
  • Assist with consultant, hospital, and vendor contract tracking for signatures.
 
What You’re Bringing with You
  • Bachelor’s degree with coursework in clinical research (or relevant discipline) or 1+ years of hands-on clinical administrative support experience.
  • Good written and verbal communication skills and able to multitask.
  • Proficiency in MS Word, MS Excel, MS PowerPoint and MS Outlook. Experience with cloud-based systems, such as Florence and Anju, other clinical trial management software platforms, such as Salesforce and Tableau, a plus but not required.
  • Knowledge of operating standard office equipment.
  • Excellent organizational skills.
  • Strong problem-solving skills.
  • Conscientious person with an outstanding work ethic and strong personal discipline.

Compensation & Benefits

Annual Base Salary Range: $ 45,000-50,000
  • Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility

Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees.  The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.

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 the 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.

Clinical Trial Manager

Clinical Trial Manager
Marlton, NJ
 
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.
 
The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines.  Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics.  In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.

Reporting to the Senior Clinical Trial Manager, the CTM is responsible for the management of all aspects of the clinical trial team activities for the assigned clinical trial(s). The CTM, together with Clinical and Medical leadership, is responsible for clinical operational oversight and execution (initiation, enrollment, and completion) of complex medical device clinical trials.

The CTM will manage the assigned clinical trial(s) in adherence to Good Clinical Practices (ICH/GCPs) and in compliance with appropriate company Standard Operating Procedures (SOPs) as applicable under the regulatory agency(ies) governing the study, and any other applicable guidelines and regulations.
 
The CTM is responsible for independently managing a range of activities for multi-center, single-arm, medical device clinical studies in the US. This position requires strong leadership skills and the ability to manage people, meet clinical project goals and timelines, and be in alignment with company initiatives.
 
How You’ll Add Value
  • Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, case report forms, monitoring plans, data management plans, and any other clinical research-related documents.
  • Proactively coordinate, manage and oversee the various project-level operational aspects of the CTT including management of trial timeline, budget, resources, and vendors.
  • Provide regular updates on trial progress to clinical leadership with respect to vendor selection, project plans, trial budget and timeline management, and risk mitigation.
  • Lead study startup processes, including but not limited to conduct of the clinical trial Investigator meeting together with clinical and medical leadership, site selection, and finalization of site clinical trial site agreements and budgets.
  • Ensure effective project plans are in place and operational and work proactively with the CTT to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.
  • Ensure potential study risks are escalated to the attention of clinical leadership when appropriate.
  • Lead the CTT working group and vendor status update meetings.
  • Ensure tracking, follow-up, and resolution of site monitoring issues in a timely manner.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team.
  • Support all activities related to clinical trial oversight committees (Steering Committee, DSMB, Clinical Events Committee).
  • Assist with CRA and third-party vendor training on protocols and practices.
  • Develop and maintain good working relationships with investigators and study staff.
  • Contribute to writing annual progress reports and final reports to regulators, as required.
What You’re Bringing with You
  • Bachelor’s degree or higher, in a scientific, clinical, or related field
  • For Associate CTM: Minimum of 2 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industries. Experience supporting multicenter clinical studies preferred
  • For CTM: Minimum of 4 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization CRO) industries. Demonstrated experience independently managing clinical studies or major study workstreams.
  • Hands-on-experience managing or supporting Investigational Device Exemption (IDE) clinical trials is required.
  • Working knowledge of FDA regulations, ICH-GCP, and clinical trial best practices.
  • Strong project management, organizational, and problem-solving skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Excellent written, verbal, and interpersonal communication skills.
  • Proficiency with Microsoft Office applications and clinical trial management systems.
  • Preferred: Prior experience in heart failure and/or cardiac rhythm management clinical studies is strongly preferred. Experience managing CROs and external vendors.
 
Compensation & Benefits

Annual Base Salary Range: $ 95,000 - 115,000
  • Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility

Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees.  The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.
 
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 the 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.

 

Clinical Research Associate

Clinical Research Associate
Marlton, NJ
 
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.
 
The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines.  Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics.  In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.
 
How You’ll 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, and 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 the 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, and 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’re Bringing with You
  • 1-2 years of clinical research experience with a bachelor’s degree and/or
  • 4 years of clinical research experience with professional certification (CCRP, ACRP)
  • Experience with communicating with hospital administrators, research nurses, and study coordinators.
  • Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements.
  • Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions.
  • Medical device and/or heart failure clinical trials experience preferred.
  • Bachelor’s degree in life sciences or related field preferred or equivalent work 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 the 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.
 

Annual Base Salary Range: $ 60,000 - $ 75,000

 

  • Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility


Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees.  The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.

 
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.
 

ID - 8a78839f9f4435e9019f62974ff5143f

Clinical Trial Assistant

Location: United States Marlton NJ 08053
Apply
Clinical Trial Assistant
Marlton, NJ

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.

The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines.  Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics.  In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.

The CTA at Impulse Dynamics is a conscientious and detail-oriented person who enjoys making a difference and takes pride in their career to work in our fast-paced office.

How You’ll Add Value
  • Review and process all site invoices. Generate and obtain signatures for Purchase Request Forms, Purchase Orders. Oversee accounts receivable reconciliation.
  • Responsible for purchasing scientific journal articles and uploading them to a central repository.
  • Organize, maintain, and audit department files in compliance with department standard operating procedures.
  • Maintain electronic and hard copy filing systems (CTMS, Egnyte, and Florence).
  • Schedule and coordinate occasional meetings, appointments and travel arrangements for internal and external meetings and personnel.
  • Assist with the preparation of department PowerPoint presentations, meeting minutes and action items tracking.
  • Provide general administrative support including mailing, printing, scanning, shipping and copying.
  • May interact with internal and external contacts regarding clinical trials.
  • Open, sort and distribute incoming correspondence.
  • Run errands to post office and office supply stores, as needed.
  • Assist with consultant, hospital, and vendor contract tracking for signatures.
 
What You’re Bringing with You
  • Bachelor’s degree with coursework in clinical research (or relevant discipline) or 1+ years of hands-on clinical administrative support experience.
  • Good written and verbal communication skills and able to multitask.
  • Proficiency in MS Word, MS Excel, MS PowerPoint and MS Outlook. Experience with cloud-based systems, such as Florence and Anju, other clinical trial management software platforms, such as Salesforce and Tableau, a plus but not required.
  • Knowledge of operating standard office equipment.
  • Excellent organizational skills.
  • Strong problem-solving skills.
  • Conscientious person with an outstanding work ethic and strong personal discipline.

Compensation & Benefits

Annual Base Salary Range: $ 45,000-50,000
  • Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility

Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees.  The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.

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 the 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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