Pre-Clinical / Clinical Research Associate

Avery Therapeutics, Inc. is a leader in the development of next-generation bioengineered therapeutics for cardiac diseases, such as chronic heart failure. Avery’s dedicated and passionate team has the unique privilege of making significant contributions to groundbreaking therapies that address large unmet medical needs. As a late-stage pre-clinical company, each member is a difference maker and is paving the path for novel and needed treatments.

Avery is recruiting an experienced Pre-clinical/Clinical Research Associate with deep experience in pre-clinical and early-clinical-stages of product development. The Clinical Specialist will oversee on-site pre-clinical activities at contract research organizations (in Grand Rapids, MI) and clinical trial activities at clinical sites (in Minneapolis, MN), provide guidance to collaborators and bring feedback to the product development, regulatory, quality and clinical teams. This role will be focused on the development of Avery’s MyCardia, an epicardially-placed viable cardiac matrix in development for treatment of chronic heart failure.

This is a new role which is well suited for a talented, self-motivated individual, able to work independently but eager to collaborate, and ready to set a new standard at our firm.

In your application, please include a cover letter describing your interest and qualifications, a CV or resume, and any relevant publications.

Position: Pre-clinical/Clinical Research Associate

Timeline: Immediate

Job Location: Tucson, AZ, Grand Rapids, MI, Minneapolis, MN. Frequent travel required.

Compensation: $90,000 - $130,000 DOE

Compensation and Benefits:

Retirement plan with company match

Relocation assistance (if applicable)

Professional development

Desired Skills and Experience:

· Pre-clinical development

· Pre-clinical models of cardiac disease

· Project management

· Good clinical practices

· Good laboratory practices

· Good documentation practices

· Clinical trials in cardiovascular field

· Implantable medical devices and/or biologics

Duties and Responsibilities:

· Frequent travel primarily to Grand Rapids, MI, Minneapolis, MN and surrounding areas. Occasional travel to Tucson, AZ, New York, NY and other locations.

· Develop understanding of clinical needs and use of Avery products in the pre-clinical and clinical setting

· Create training program and perform training on handling MyCardia to pre-clinical and clinical collaborators

· Collect feedback on use of product and communicate to product development team

· Provide case support for clinical studies

· Prepare clinical literature reviews

· Compile, review, document, present, and report to executive team

· Assist in development and documentation for clinical protocols, instructions for use, regulatory submissions, etc.

· Support company quality and regulatory operations

· Oversee pre-clinical and clinical research activities by communicating with study staff, and monitoring (ensure compliance) and documenting progress

· Establish and maintain appropriate procedures within the quality system

· Develop, document, and revise standard operating procedures and support document control processes

· Provide leadership and collaborate with internal and external personnel on research activities

· Collaborate with and deliver technical information to team members, company executives, quality consultants, regulatory consultants, CMC consultants, and contract organizations

· Maintain and distribute study records, documents, and materials

· Perform inspection of sites, activities, and documentation for audit readiness

· Prepare reports and publications

· Attend and present at clinical and scientific-related meetings

Required:

· U.S. Citizen or lawful permanent resident (“green card” holder)

· 5 years of experience in biotech/medical device industry

· Degree in science, engineering, nursing, medicine

· Skills in organization, communication, and attention to detail

· Experience collaborating with and overseeing work at clinical sites and contract research organizations (pre-clinical and clinical)

· Knowledge of Good Clinical Practices, Good Laboratory Practices and Good Documentation Practices

· Knowledge of FDA CFRs and relevant guidance documents

* Covid vaccination required

* Negative TB test required

Avery Therapeutics is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

Job Type: Full-time

Pay: $90,000.00 - $130,000.00 per year

Benefits:

• Paid time off

Schedule:

• 8 hour shift

Work Location: One location