CLINICAL TRIALS COORDINATOR III (Lead Sonographer)
Duke University - Durham, NC

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Occupational Summary

Under the direction of the CV Imaging faculty director and the senior
project leader, the lead
sonographer at the DCRI Imaging Core Laboratory is responsible for the
quality, timeliness and
efficiency of image interpretation through development of protocols and
other study documents,
training personnel, ongoing QA and excellence in analysis. In addition,
the lead sonographer
participates in assuring that the core lab processes for receipt,
processing, tracking and reading of
the ECHO studies submitted by the participating sites are developed and
consistently followed
according to Good Clinical Practices.

Work Performed
Oversees the image interpretation process for an imaging core lab study
ensuring timely, accurate and
reproducible core lab analysis of images following approved standard
operating procedures. Also
functions as one of the study#s senior readers. Assists with
administrative, technical and
interpretation of imaging studies.

Collaborates with the director, study PI, the project leader and other
team members to develop and
maintain standard operating procedures, image acquisition protocols,
image charters, internal work
instructions, project case report forms, and instructions, including
the design, testing and deployment
of internal analysis and/or EDC databases.

Provides leadership in the imaging core lab for single and/or
multicenter clinical trials by ensuring all
project staff are compliant and trained on SOP#s and Work Instructions
for the collection, processing
and analysis of imaging data and/or administration of the core lab
while adhering to study timelines,
protocols, institutional research policies and government regulations.

Oversees and develops project specific and generic staff, MD reader
instructions and site training
programs. Is responsible for assuring that all training material
content appropriately describes efficient
and effective means of obtaining the images required by protocol and
works closely with the sites, the
core lab staff and the MD readers to implement the processes described.

Coordinates timely completion of initial and ongoing quality control
processes as described in the QC
plan and additionally as needed in collaboration with the project
leader and PI.

Acts as primary liaison with vendors and works with DCRI IT as the
subject matter expert (SME) to
provide technical support needed to optimize the use of the analysis
software and to trouble shoot
any technical problems that arise. The lead sonographer is a technical
resource for participating
sites, participates in the review of new software and supports
validation efforts under guidance of
project leader.

Performs and oversees data entry, file management, verification of
study information, tracking and
data exports.

Actively participates in weekly lab meetings, conference calls and
other related duties as needed.

Communicates quality, technical, logistical and data management issues
to the project team and
contributes to problem solving regarding these issues.

Attends meetings and conferences relevant to core lab research and
echocardiography to ensure
continuing educational and professional growth.

Cultivates a collaborative and cooperative work environment with the
clinical echo lab, clinical lab
leadership and personnel, and clinical sonographers. Maintains a high
level of performance of duties
assigned during #clinical lab time#.

Performs weekly time tracking and/or effort documentation following
Duke requirements

Assists in recruiting and retaining full and part time core lab
sonographers.

Minimum Qualifications:
# Two years of allied health degree with a focus in cardiovascular
and/or cardiopulmonary physiology
and two years full time, predominately, echocardiographic imaging
experience or Bachelor#s degree
# Graduate of a cardiac ultrasound program
# Certified by ARDMS as a Registered Diagnostic Cardiac Sonographer
(RDCS) or by CCI as a
Registered Cardiac Sonographer (RCS)
# Excellent knowledge of M-mode, 2D and Doppler calculations and
cardiac hemodynamics
# 3 or more years experience as a clinical sonographer in an academic
echo lab
# Prior research experience is highly desirable. Minimum Qualifications
Education Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three years of healthcare experience; or one of the following equivalents: 1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2. Completion of a Master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or 3. Completion of a Bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a Bachelor's degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**
Experience None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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