PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Posts: Imaging Research Associate
Job Description:
Essential Function
Convert medical image data to digital form. Perform analysis on medical images for a clinical trial. Develop and coordinate study related procedures in compliance with FDA Regulatory Requirements. Institute and resolve queries with investigator sites and academic centers to ensure follow-up on imaging-related issues. Validate and maintain a database of medical images and associated results.
Key Accountabilities
- Perform quality assurance checks on study images.
- Validate and maintain imaging database including images and tracking and review results for assigned projects.
- Ensure the site personnel have a good understanding of the protocol, the requirements of the study so that they can fulfill their obligations to complete their study accurately.
- Perform established image processing techniques (including the downloading of imaging data from foreign media, region of interest measurements, video system specific processing) across multiple modalities (including but not limited to CT, MRI, Nuclear Medicine, Ultrasound) using proprietary software, Alice, as well as other third party packages as appropriate.
- Mentor and assist in training of internal personnel.
- Assist with preparations and present for Operations overview at client investigator meetings to ensure that the team is well informed of the ongoing results.
- Provide training and test independent reviewers on PAREXEL procedures and policies.
- Performs preliminary review of measurements.
- Collect and analyze findings on images, present to independent reviewer and/or medical review staff with result of findings.
- Act as liaison with radiologists at academic centers and work to resolve issues that arise throughout the clinical trial.
- Author documentation pertaining to Standard Operating Procedures (SOPs) as well as project specific procedures including Core Imaging Lab Manual and Site Manual.
- Monitoring within assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21CFR Part 11), applicable departmental and company wide SOPs, and project specific protocol compliance.
- Perform any other duties as required by the position
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Experience:
Skills
- Proficient in Microsoft Office of products including Word, Excel, PowerPoint.
- Experience with database applications preferred.
Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: other
End Date: 30th Jan, 2014
Req ID: pare-10031088
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