Offer summary

Qualifications:

Completed a bachelor’s degree in a related field., 2-5 years of experience in Clinical Research with a focus on health services and outcomes research., Strong knowledge of study data generation, protocol design, and regulatory compliance., Impeccable organizational skills and ability to manage multiple projects effectively..

Key responsabilities:

Develop and maintain the clinical research roadmap for assigned projects and collaborate across departments.

Lead the design, planning, and execution of clinical studies, including site selection and protocol development.

Build relationships with study site partners to advance Eko’s research interests and meet evidence needs.

Ensure compliance with SOPs and help develop tools to enhance research team efficiency.

Job description

At Eko, we’re dedicated to providing healthcare professionals with industry leading digital tools to hear and understand their patients’ hearts and lungs. With our platform, clinicians can detect cardiopulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible.

With over $165M in funding from partners like 3M and the Mayo Clinic, Eko has become one of the fastest growing digital health companies, doubling our customer base in the last year to over 500,000 clinicians across 4,000 U.S. hospitals. We’ve built a tremendously talented, diverse, and mission driven team and are proud to be certified as a Great Place to Work®. Together we are committed to investing in each other and our mission to ensure all patients have access to high quality care.

The part-time Clinical Research Associate will be responsible for designing and conducting algorithm development studies to support development of AI products in the cardiopulmonary space. This person will have strong analytical abilities and will be comfortable working with data, from gathering and analysis, through to design and presentation. The associate will also need to be comfortable with associated regulatory reporting (FDA & EU-MDR standards, ISO14155, public reporting on clinicaltrials.gov, etc). This is an exciting part-time role that would be great for a student or someone looking for flexibility in their schedule. The role will have the possibility of expanding to a full-time position in the future. The ideal candidate has expertise in algorithm or AI research, and will be primarily responsible for data collection for cutting-edge medical device development (AI, hardware, and telehealth platform).

As Clinical Research Associate at Eko, You Will:

Develop and maintain the clinical research roadmap for assigned projects; collaborate across company departments to create project plans for each research opportunity; prioritize based on timeline, cost, and impact; and bring proposals to internal stakeholders for approval.

Serve as lead for the design, planning, and execution of the clinical studies assigned to you and analyses, including site selection, protocol development, budget and contract negotiations, data monitoring, as well as final analyses and preparation of abstracts and manuscripts

Develop strong relationships with internal and external study site partners to anticipate the evolving landscape and identify opportunities to advance Eko’s methodological, data source, and technological interests in order to meet the evidence needs of regulators, payers, providers, and patients.

Ensure compliance with applicable standard operating procedures (SOPs) in all activities; help to develop tools, documents, and systems that enable the entire research team to be more efficient & effective.

As Clinical Research Associate at Eko, You Have:

Completed a bachelor’s degree

2-5 years of experience in Clinical Research with direct involvement in health services, outcomes research, and in the analysis of study data and generation of regulatory compliance reports related to research studies

An understanding of the evolving landscape of NIH grants and budget and funding sources

Strong knowledge of various aspects of study data generation and implementation including managing study site relationships, clinical registry management, protocol design, oversight of data acquisition, program plan development, data analysis, KOL engagement, and the development of research findings into posters/presentations/ publications in alignment with company strategy.

Ability to manage multiple projects; triage multiple requests simultaneously and prioritize research projects

Experience with end-to-end project management, including planning, designing, and leading research projects, securing necessary resources for execution, and communicating effectively with multiple stakeholders

Experience with managing ongoing, multisite clinical studies to ensure data quality is being maintained, enrollment targets are being met, and any issues are triaged and resolved while minimizing impact to data collection

Extensive experience with study design, including writing clinical study protocols, consent forms, case report forms, and other study materials for IRB submission; strong understanding of clinical research techniques and principles (HIPAA, ICH-GCP)

Impeccable organizational skills with meticulous attention to detail and a tendency to think 10 steps ahead

Natural problem-solver, autonomous self-starter, ability to handle ambiguity, good business judgment, and a “roll up your sleeves” work style

As Clinical Research Associate at Eko, Nice to have:

BA/BS or Master's degree in related disciplines, such as Public Health, Pre-medicine, Biostatistics from an accredited institution.

SBIR or NIH grant experience or experience providing federally funded budgets as a study sponsor.

Experience in medical devices, sponsored research (including pharmaceutical companies), or software as a medical device

Familiarity with AI/algorithm development process; able to rapidly acquire familiarity with emergent technologies and software algorithms

Working knowledge of cardiovascular, pulmonary, and vascular diseases

Benefits and Perks We Offer:

Eko was recognized by “Great Place to Work” in 2020 and 2021

Paid-time off

Medical/Dental/Vision, Disability + Life Insurance

One Medical membership

Parental Leave

401k Matching

Work from home equipment stipend

Flexible schedules

Wellness programs (Wellness Wednesdays, Time off)

Wellness perks (Headspace, Ginger, Aaptiv, Physera)

Learning and Development stipend

Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through telehealth. The company is headquartered in Oakland, California and privately-held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others.

Eko is proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives. We celebrate diversity and are committed to building a diverse and inclusive team.

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