What are the responsibilities and job description for the Clinical Trial Liaison (Central US) position at Impulse Dynamics (USA), Inc.?
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 Department is responsible for executing clinical studies in full compliance of 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 towards innovation and operational excellence. You will be joining a team that is committed to meaningfully advance the science of heart failure treatment for a global community of patients and their healthcare providers.
The primary responsibility of the Clinical Trial Liaison (CTL) is to manage assigned clinical sites during the life cycle of clinical research: study start-up activities, study recruitment, device implantation, and follow-up study phases. In addition, the CTL will support site initiation visits, clinical education, data collection oversight, implementation of subject recruitment strategies, and communicating with appropriate site staff and investigators for the successful completion of Impulse Dynamics clinical studies.
How You'll Add Value
- Work with both the clinical and administrative departments, and the hospitals to create a collaborative and strong research relationship.
- Educate and train site research staff on the clinical protocol and scientific rationale for Impulse Dynamics products.
- Must be able to communicate current and relevant heart failure, device data, and clinical trends as they relate to the appropriate use of Impulse Dynamics products and the treatment of our targeted study population.
- Attend clinical cases and/or study follow-up visits as needed to ensure proper data collection and adherence to protocol.
- Perform, oversee, and work closely with in-house or contracted staff to comply with GCP guidelines completely and accurately in the collection of study data.
- Achieve regional enrollment goals on a monthly, quarterly, and annual basis
- Develop a strong working relationship with all members of the clinical affairs team.
- Collaboration with other functional domains of the organization to achieve common goals.
- Facilitate opening new regional clinical trial sites in a timely manner
- Ensure that study related issues at assigned sites are well documented and resolved in a timely manner.
- Ensure that all regulatory requirements of clinical trial reporting at assigned sites are met accurately and expeditiously
- Capture clinical experiences at sites to improve understanding of product behavior, improve product performance and product acceptance by customers.
- Coordinate and support educational activities as requested.
- Accelerate enrollment through subject referral and awareness initiatives
What You're Bringing with You
- 5 years experience in Life, Health Sciences, Nursing or Biomedical Engineering field
- 5 years experience in Clinical research
- Strong working knowledge of medical device industry
- Proven ability to develop new clinical relationships and foster existing clinical relationships
- Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
- Experience training investigators and research teams on clinical protocols
- Excellent oral and written communication skills
- Bachelor's or graduate degree in Life Sciences, Nursing, Biomedical Engineering, or equivalent education/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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