Join the AcuamarkDx Team

Who We Are

AcuamarkDx is a research-stage diagnostics company focusing on developing technology that allows for highly accurate screening of blood to detect cancer markers at the early cancer stages. Backed by a highly experienced team of scientific and business professionals, our mission is to contribute to the global battle against cancer by detecting and attacking cancer through high-precision, early detection.

We aim to become a global leader in providing best-in-class, radically disruptive diagnostics detection tools for more reliable and convenient disease detection and monitoring. Our goal is to reduce death rates, enable the best quality of life, and help provide the lowest cost care to patients and society.

AcuamarkDx has a strong foundation of inclusion and diversity, employee appreciation, resilient leadership, innovation, and expertise. A successful team is built on active involvement, cooperation, creativity, and support for all employees to achieve our goals. As a part of our team, you will embark on an enriching career and make a vast, beneficial impact on society. Working at Acuamark provides you with lots of room to grow while having fun! We sincerely hope you will consider joining us and being an essential part of the mission and our story.

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What We Value

We have built Acuamark's culture based on our values, which reflect the inherent traits of our employees and guide our hiring and daily decision-making. We commit to these values as they are central to our mission and our impact on communities.

We work with resilience, drive, and purpose because we believe and love what we do and why we do it. We continuously move forward, innovate, and improve.

We create with compassion for the betterment of humankind. We tackle unprecedented scientific challenges utilizing revolutionary thinking, leveraging collective genius, and maintaining a culture of constructive collaboration.

We owe it to eachother to be transparent with each other and our work. We listen to the biology and are unapologetic about accepting the biological challenges we have taken on and the goals we pursue.

We respectfully and ethically interact with each other and those we serve. We stand against racism, bigotry, harassment, and discrimination. We seek out and foster diversity.

The Acuamark Opportunity

Joining AcuamarkDx allows you to work with a knowledgeable and innovative team of professionals with a passion for meaningful change.

We believe every employee adds valuable skills, experiences, and perspectives to our team, making us more creative and collaborative and increasing productivity and efficiency in the products we deliver.

As an AcuamarkDx employee, you will be a part of a productive, fulfilling, and enjoyable workplace. You will engage in positive collaboration with management and your fellow employees and actively live out our Company values, fostering our culture of respect, diversity, equity, and inclusion. We will expect you to dive right in!

We celebrate and savor differences. Our team believes that a diverse and balanced workforce adds professional rigor, improves our business, and best represents our purpose, our goals, and the population we aim to serve. What to expect in a career with AcuamarkDx:

Fast-paced environment working with talented team members
Ground-breaking work
High potential for growth and mobility in the company
A focus on balance through a reduced workweek and generous vacation time
An environment of mutual respect and care

Available Positions

Clinical Research Manager

Title: Clinical Research Manager

FLSA: Non-exempt

Reports To: Director of Operations, VP Clinical/Regulatory, CEO

Location: New York/California

Job Summary:

In this position, you will be overseeing the assigned clinical research for Acuamark’s high-impact, ground breaking early-cancer detection work aimed at benefiting society on a vast scale, and interacting collaboratively with a team of stellar and passionate colleagues.

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Job Description

Title: Clinical Research Manager

FLSA: Non-exempt

Reports To: Director of Operations, VP Clinical/Regulatory, CEO

Location: New York/California

Job Summary:

Concretely, you will be responsible for supervising a portion of of Acuamark’s clinical studies, patient recruitment and sample collections. You will supervise both site-based as well as company-based research personnel – e.g. CRN’s, CRA’s, CRC’s, 3^rd party auditors - and have full responsibility for all aspects of the assigned clinical studies, including but not limited to study preparations, site preparations, site and staff training, quality control, targeted enrollments, site performance, training recommendations, monitoring shipping, storage, sample processing quality aspects, SOPs, etc. Other responsibilities include administering questionnaires and subject material, assuring that studies and study personnel adhere to regulatory and ICH GCP trial standards, and participating in subject recruitment efforts, among other duties. Additionally, this position may need to engage hands-on with research subjects and ground staff to address any concerns and ensure they know what is expected of them.

The role requires seamless collaboration in a cross-disciplinary fashion between Acuamark’s sites as well as the academic lab and commercialization lab teams. As the clinical study work escalates multifold, your key role will become even more crucial, offering ample opportunity to grow without ceiling. You will be exposed to top-notch education and training where needed, and AcuamarkDx will prepare you to grow rapidly.

Our ideal candidate is a person who is looking to work on meaningful technology that has the potential to make a lasting impact. This candidate must be able to work in a dynamic environment, have demonstrable and extensive hands-on experience in clinical trial conduct as a CRA and/or CRN, and a CRC, and be ready for a next step or has recently become a CRM. We are looking for a person who cares while being driven, independent and conscientious. This candidate should be able to communicate effectively, have a high-level of emotional intelligence, and be a pragmatic problem solver. Travel will be required. Spanish/Portuguese language proficiency is not necessary but would be considered a plus. Formal project management training is not a necessity but familiarity is a plus. The Company may consider providing education and training as needed.

Key Duties and Responsibilities:

Oversee the smooth running of clinical trials, functioning as the primary PM for the clinical trials, including facilitating the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, maintaining communication cross-functionally, and overseeing the lifecycle of the study
Manage research budgets
Interface with sites, commercialization lab, academic lab, CRO’s and company management. Work closely with the leadership team to develop and implement guidance documents, work instructions, report team study metrics, and communicate issues that may affect overall research with clinical trials.
Provide frontline day to day clinical research operations leadership through supervision and management of CRN/CRA/CRCs involved with clinical studies including training and development needs
Monitor study, protocol and SOP compliance; Maintain current regulatory inspection knowledge as it relates to GCP inspections and audits.
Monitor data collection and data completeness
Monitor subject and sample recruitment
Monitor sample processing, shipment, labeling, storage
Organize site auditing
Be the go-to resource for all clinical trial logistic questions and problems
Participate in subject recruitment efforts
Inform participants about study objectives
Administer questionnaires
Engage with subjects
Monitor research participants to ensure adherence to study rules
Maintain detailed records of studies as per FDA guidelines
Liaise with laboratories regarding findings
Direct the collection, labeling, storage and transport of all specimens
Ensure that the necessary supplies and equipment for a study are in stock and in working order
Other duties as assigned

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

Education & Certification:

Bachelor’s degree in Nursing, Clinical Research Science, or related field

Experience:

5+ years’ experience in clinical trial conduct

Willingness to continually self-educate
Experience in executing clinical studies is required preferred
Ideal candidate would have several years of hands-on experience as Clinical Research Nurse, and/or Clinical Research Assistant and Clinical Research Coordinator) and may have experience as a CRM

Technical Skills:

ICH GCP certified
Experience in clinical trial conduct and audits
Ability to adequately work with - and supervise - various electronic Data Capture systems (eDC),Clinical Data Management Systems (CDMS) and Clinical Trial Management Systems (e.g.. electronic Trial Master File systems)

Soft Skills:

Highly organized, meticulous and detail-oriented
Strong administrative skills and drive towards efficiency
Ability to think analytically, apply sound judgement and solve problems
Strong interpersonal, verbal, and written communication skills
Goal and target-oriented
Ability to work effectively, and take lead on projects with minimal supervision
Ability to multi-task and work in a fast-paced environment under tight deadlines
Strong understanding of healthcare compliance regulations and processes
Excellence in program management, including scenario assessment, risk assessment and contingency planning.
Embody a culture of improvement and progress; promote knowledge sharing.
Adhere to research regulatory and ethical standards
Deep familiarity with and understanding of GCP ICH standards and SOPs

Physical Requirements:

Must be able to pass pre-employment screening that includes background and drug testing
Ability to sit and/or stand at a desk for 6-8 hours a day
Ability to work on a computer for 6-8 hours a day
Ability to travel up to 35%, and possibly work long and unpredictable hours

Disclaimer: All job requirements are subject to possible revision to reflect changes in the position requirements. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and expectations.