Clinical Research Assistant and SoftVue Scan Specialist

Background:

Delphinus Medical Technologies, Inc. is sponsoring a nationwide, multi-center, prospective, data collection project using SoftVue™ Automated Whole Breast Ultrasound in conjunction with digital 3D mammography.

Delphinus company website: http://www.delphinusmt.com/

Over 10,000 women will be enrolled at participating clinical sites across the country in 2016 and 2017. The data collected will be used for future research studies for the FDA PMA approval of SoftVue™ for screening. SoftVue™ currently has 510(k) diagnostic clearance from the FDA, but Delphinus is collecting more data from asymptomatic women with dense breast tissue in order to evaluate the safety and effectiveness for a new indication for use of this breakthrough imaging technology.

SoftVue™ Website: http://www.discoversoftvue.com

Special Objectives:

Research Assistants will be fully dedicated to supporting the conduct of the data collection project by radiologists at participating hospitals and clinics. These high‐volume breast imaging practices will have an objective to recruit and enroll more than 50 qualified volunteers per week, or an average of at least 10 patients per day. A full time Clinical Research Coordinator will also be assigned to manage the project at the site and will be responsible for all protocol procedures.

The Research Assistant and Clinical Research Coordinator will work together to market the program regionally in the community, identify and recruit potential participants from the site mammography screening schedule, evaluate eligibility and obtain informed consent. After the subject has provided consent, the Research Assistant will fulfill the role of the SoftVue™ Scan Specialist and perform the SoftVue™ scan. Radiologists will be performing interpretations of the breast imaging exams and the Research Assistant will help the Clinical Research Coordinator obtain the medical images, results, and data from the medical records at the breast center. An online electronic data capture system will be used to collect data on electronic case report forms, which will be completed by the Clinical Research Coordinator and Research Assistant. Patients who enroll in the program will be followed for at least one year and the Research Assistant will work to retain them to complete their next annual mammogram on time.

 

General Responsibilities:

This role will make key contributions to the integrity, quality, and success of the breast imaging center’s research programs, which, in turn, will impact the evaluation and regulatory approval of the SoftVue™ Automated Whole Breast Ultrasound device by the FDA. Whether or not the SoftVue™ technology becomes available to women in the future as a breast cancer screening will be directly affected by the Investigators, Research Assistants, and Research Coordinators who are involved in this project, which is why the experience, reliability, and good character of these individuals is so important to Delphinus.

The primary responsibilities of this role will be to ensure successful completion of the project by the participating hospital or clinic:

  1. Collaborates with clinical site staff, and site investigators to drive successful execution of the prospective case collection protocol
  2. Establishes a positive, cooperative, open, encouraging, and helpful relationship with clinical site staff and site investigators
  3. Takes the initiative to develop any necessary aids to allow sites to follow the protocol and complete it efficiently and successfully
  4. Assists in study start-up activities including collection and review of regulatory documents to establish site/staff qualification
  5. Recruits participants, evaluates eligibility, documents consent, performs SoftVue™ scans, as needed, and completes data entry
  6. Ensures timely query resolution on electronic case report forms
  7. Ensures all personnel at study sites have current and complete training records on file according to Delphinus’ requirements
  8. Performs image data retrieval, de-identification, and backup
  9. Presents information about the project to potential participants, as a part of the Informed Consent Discussion, and answers questions
  10. Performs community outreach and education about the project, SoftVue™, breast cancer screening, and dense breast tissue
  11. Independently performs self-audits of data accuracy, image quality, and required documentation, to prepare for monitoring visits
  12. Maintains frequent communication and regular contact Delphinus representatives to facilitate monitoring of GCP/ICH/protocol compliance, and optimization of recruitment/enrollment rates
  13. Communicates project-specific information to/from Delphinus, documents communication, and escalates serious issues to site management and other appropriate persons in a timely manner
  14. Performs central IRB submissions, completes central IRB status reports, and notifies the central IRB of project/staff changes
  15. Assists with support of routine monitoring visits and FDA audits
  16. Works constructively with site management, administrative staff and Delphinus representatives to prevent, address and resolve issues
  17. Proactively mitigates risks to meet established timelines and ensure fulfillment of recruitment/enrollment objectives at clinical sites, which will exceed an average of 10 SoftVue™ scans per day
Supervisory Responsibilities:

N/A

Requirements & Qualifications:
  1. Bachelors or Associates Degree in a Health Science
  2. At least 2 years of clinical research experience in the healthcare, biotechnology, medical device, and/or pharmaceutical industry
  3. At least 1 year of experience coordinating a clinical trial
  4. Knowledge of FDA PMA approval process, medical terminology and clinical trial requirements for medical imaging devices
  5. Excellent understanding of ICH GCP and monitoring practices with a track record for ensuring high quality data and performing effective site management while maintaining a positive and cooperative working relationship with site staff and investigators
  6. Possess excellent writing, verbal communication, interpersonal and diplomacy skills, with the character of a strong leader
  7. Professional demeanor and appearance that reflects competency
  8. Must have high degree of accuracy and attention to detail
  9. Proficient in MS Office, ClinicalTrials.gov, online IRB submission applications, HIS/RIS, PACS and hospital worklist functionality
  10. Experience using electronic data capture for data entry, query resolution, source verification, monitoring and progress reporting
  11. Organized and able to produce high quality work and independently meet critical deadlines as well as work cooperatively as part of a multi-disciplinary team to meet larger objectives
  12. Possess excellent interpersonal and diplomacy skills, with the good character of a health care provider patients will respect and trust
  13. Ability to satisfy all requirements for employment or contract by the hospital or clinic, which could include, but may not be limited to: Physical Exam, Tuberculosis Testing, 10 Panel Drug Screen, Tobacco/Nicotine Screening, Flu Vaccine, MMR Vaccine, Hepatitis-B Vaccine, Hepatitis-A Vaccine, TDAP Vaccine, Varicella Vaccine, Criminal Background Check, OIG/HHS Abuse Check, Education and Credentials/Licensure Verification, CPR Basic Life Support Training
Preferred Skills and Experience:
  1. At least 1 year of clinical research experience in the healthcare, biotechnology, medical device, and/or pharmaceutical industry
  2. Women’s Health care experience working in an intimate care setting
  3. Registered Nurse, Radiology Technologist, Medical Sonographer, or Bachelor’s Degree in a Health Science
  4. Proficient in online IRB submission applications, electronic medical records, HIS/RIS, PACS and hospital worklist functionality
  5. Experience using electronic data capture for data entry, query resolution, source verification, monitoring and progress reporting
Application Process:

Delphinus Medical Technologies will pre-screen applicants before referring desired candidates to the participating hospital or clinic for further evaluation, interviews, and selection of the person who is the best fit for the project needs and job culture at the breast center. This position will belong to and be directly managed by the participating hospital or clinic, not to Delphinus medical technologies. If you’re interested in applying for a this position, please contact:

Heather Rone, Vice President of Clinical Affairs
Delphinus Medical Technologies
hrone@delphinusmt.com

 

Apply