Clinical Research Associate-Imaging

at  Cardiovascular Research Foundation

SUMMARY

Under general supervision and within the framework of Phase I-IV clinical trials, is responsible for performing a series of qualitative and quantitative analyses of patient angiographic films.

QUALIFICATIONS

• B.S. Degree in Biology or other Life Science. Medical background preferred.
• 0 - 2 years working experience in a medical, academic or pharmaceutical environment.
• Knowledge of medical terminology and morphology of the heart preferred.
• Must be proficient in Microsoft Excel, Word, and Outlook.
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to prioritize.
• Ability to verbally communicate effectively with staff, physicians, nurses, managers, trial sponsors and colleagues. Ability to communicate effectively when reading and writing e-mail, letters, Manual of Operations, Case Report Forms and other reports or company documents.
• Ability to analyze information and solve problems relating to images viewed on angiographic patient films and on case report forms.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Checks materials sent to the Core Lab for completion of Technician’s Worksheet, patient identification code, clinical site identification number, initial procedure data and identification of catheter used for micrometry.
• Assesses consistency between the film and the Technician’s Worksheet on filming of the catheter, correctness of designated segments and overall quality of filmed projections.
• Selects film frames that are most suitable for analysis and recording selected frames on Case Report Form.
• Records any deficiencies in angiographic acquisition on the feedback sheet.
• Traces/draws pre-interventional arterial segment on Case Report Form and recording the corresponding frame number and projection (angulation and skew) on Case Report Form.
• Records measurement and location of catheter on Case Report Form.
• Records baseline, final, and other selected time point morphology on the Case Report Form.
• Upon successful completion of approximate 3 month training period, proceeds with quantitative coronary analysis (QCA) process utilizing the Coronary Measurement System (CMS) including: image acquisition, image calibration and segment selection.
• May conduct peripheral analyses in addition to the above coronary analyses.
• May be trained on and expected to conduct quality assurance (QA) steps.
• Additional duties as assigned.