• LinkedIn - White Circle

CLINICAL RESEARCH ASSOCIATE

Date Posted: 7/28/2020

JOB DESCRIPTION

Spectral MD, Inc.

Position Title: Clinical Research Associate

About Spectral MD, Inc.

 

Spectral MD, a mid-stage medical device company, is developing a diagnostic imaging system to support treatment decisions by healthcare professionals in the wound care market, especially burns and chronic wounds. We focus on the combination of AI and machine learning techniques with digital images to meet the needs of our clinician customers in wound management.

Position Overview:

Spectral MD is seeking a Clinical Research Associate (CRA) expert to join their growing clinical team in Dallas to assist with field and in-house clinical research work. This is a fantastic opportunity to join a fast-growing medical device company with a life changing product. Ability to manage up to 5 clinical sites, CRA experience, and availability to travel are required.

Responsibilities:

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

  • Patient recruitment and enrollment activities (tracking, reporting, motivating, etc.)

  • Ensure sites are in compliance with study protocols

  • Develop and implement clinical strategies

  • With the CTM, 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

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

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

 

Required Qualifications:

  • Bachelor’s degree required (science/health preferred)

  • Must have clinical trial experience, CRA medical device experience strongly preferred

  • Travel 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

LinkedIn

  • LinkedIn - White Circle

Follow us on LinkedIn and learn more about our culture, our people, and career opportunities!

© 2020 SpectralMD, Inc. All rights reserved.

2515 McKinney Avenue, Ste. 1000; Dallas, TX 75201

Custom website proudly designed by Cloud 10 Studios, LLC. | Site Map