Spectral MD, Inc.

Position Title: Clinical Research Associate

About Spectral MD, Inc.

Spectral MD, Inc. is an uptown Dallas based medical tech company that answers clinical questions through the development of data pipelines, artificial intelligence (“AI”) algorithms and proprietary optical technology. Spectral MD Inc.’s DeepView® Wound Imaging System (“DeepView®”) is an advanced medical device that uses a digital approach to deliver images of blood flow under the skin's surface to look deep into the body without ever touching the patient. Our mission is to provide physicians with the ability to accurately assess perfusion and wound healing potential for patients suffering from burn wounds and peripheral artery disease. We are scientists, engineers, and forward-thinkers striving to modernize the management of wound care.  

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Position Overview:

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Spectral MD, Inc. is seeking a motivated Clinical Research Associate with experience in clinical trials and the medical device field. This candidate will be responsible for conducting site visits to clinics as well and patient recruitment, and preparing, tracking and managing study documentation and supplies and contributing to Spectral MD culture of Innovation, Integrity, Respect and Passion.

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Primary Duties / Responsibilities:

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• Conduct key site visits including site qualification, initiation, routine monitoring, and close‐out visits

• Patient recruitment and enrollment activities including tracking and coordinating enrollment number and reporting to internal team

• Ensure site compliance with study protocols

• Develop and implement clinical strategies

• With the Clinical Team, responsible for establishing, managing, and meeting Clinical Trial milestones

• Ensure adherence to GCP, ICH, and FDA regulations and guidelines

• Develop training, assessment tools, job aids for both SMD team and sites

• Prepare, track, and manage required study documentation and supplies. Presents this data to Clinical Team, Project Management, or other teams as needed and/or requested. 

• Work extensively with sites and SMD to clean data and resolve urgent issues

• Liaise with Clinical Team, SMD personnel, and study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries

• Maintain credentialing requirements at hospitals and clinics as needed

• Complete projects and tasks consistent with corporate objects

• Perform other duties as assigned

• Contribute to the company culture of Innovation, Integrity, Respect and Passion

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Qualifications:

Required Education and Experience:

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• Bachelor’s degree in science, health or related field required, Master’s degree preferred

• Minimum 2 years of clinical trial experience, Clinical Research Associate in the medical device field is strongly preferred

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Knowledge, Skills, and Abilities:

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• Knowledge of GCP, ICH, and FDA regulations

• Ability and experience managing clinical activities at multiple sites

• Excellent verbal communication skills 

• Excellent interpersonal and customer service skills 

• Excellent organizational skills and attention to detail 

• Excellent time management skills with a proven ability to meet deadlines.

• Strong analytical and problem-solving skills

• Ability to prioritize tasks and to delegate them when appropriate 

• Proficient with Microsoft Office Suite or related software

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Physical Requirements:

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The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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• Prolonged periods of sitting at a desk and working on a computer

• Must be able to lift up to 15 pounds at times

Travel:

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Must be able to travel up to 75%

Spectral MD, Inc. is an equal opportunity employer and participates in E-Verify. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other characteristic protected by applicable federal, state, or local laws.