About Spectral MD, Inc.

 

Spectral MD, Inc.’s mission is to revolutionize wound care using real-time data & Artificial Intelligence. We are doctors, scientists, engineers, and forward-thinkers striving to modernize the management of wound care with our DeepView® Wound Imaging System. Our product is using color and light to innovate wound care to investigate faster, more reliable, and more predictable care.

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Position Overview:

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Spectral MD, Inc. is seeking a Senior Clinical Research Associate to join our Clinical team in Dallas, TX. The Senior Clinical Research Associate role at Spectral MD will act as a Senior Clinical Research Associate and Project manager by leading and assisting with the clinical research work of the DeepView Wound Imaging System at up to 10 clinical sites. 

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Primary Duties / Responsibilities:

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• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations. 

• Conduct and help coordinate clinical team’s key site visits including site qualification, initiation, routine monitoring visit, and close-out visits. 

• Manage multi-site patient recruitment and enrollment activities including tracking and coordinating enrollment number and reporting to internal team. 

• Provide cross-functional oversight of internal project team members and deliverable, which includes ensuring all necessary project-specific training is provided. 

• Review and provide input for study-protocol, edit check specifications, data analysis plan, and final study report, when applicable. 

• Independently manage all phases of a clinical study including essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. 

• Manage study meetings to ensure completion of established project team goals and objectives 

• Oversee qualification, site initiation, interim and close-out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. 

• Prepare clinical SOPs 

• Ensure documents and reports release and mad manage Trial Master File completeness 

• Ensure sites are in compliance with study protocols 

• Develop and implement clinical strategies 

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

• Prepare, track, and manage required study documentation and supplies 

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

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

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Qualifications:

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

• Must have 5 + years of clinical trial experience, CRA medical device experience strongly preferred 

• Project Management Experience is a plus 

• Travel to clinical sites required up to 75% 

• Thorough knowledge of GCP, ICH, and FDA regulations 

• Ability and experience managing clinical activities at multiple sites 

• Enthusiastic, self-motivated personality with a "do what it takes" attitude 

• Excellent written and verbal communication skills 

• Proficiency with Microsoft Office Suite (Excel, Outlook, Word, etc.) 

 

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Spectral MD, Inc. is an equal opportunity employer. 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.