ERT Quality Control Specialist II in St. Louis, Missouri
ERT - St Louis is looking for a PRN Quality Control Specialist II to provide review of image quality and related subject positioning and acquisition methods of clinical trial imaging data within client projects in order to assure high quality, on-time, and on-budget services while promoting excellent client service
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform and serve as a resource to others within Image QC during the Planning and Setup, Monitoring, and Closeout phases of study management to include:
Support the development of and/or understand and adhere to the study specific documents and/or elements of the Imaging Charter.
Helps to coordinate of the various teams working in support of the Study (ex: Image QC, Site and Reader Management, etc.)
Understand, be able to explain and have necessary proficiency in the software and tools used within the Imaging Study
Performing image quality review, redaction and/or image prep as specified by the direction of defined study specific parameters within the study required timelines.
Issuing queries and performing routine follow-up with study sites for resolution, informing Imaging Project & Site Management of trends or issues jeopardizing study timelines.
Collaborate with the cross functional Imaging team members and authorities to ensure the specification and use of the appropriate equipment and when a contracted service.
Creating, maintaining and distributing reports or spreadsheets in support of one or more studies.
Archiving study data and documentation through various methods.
Appropriately setting and fulfilling customer expectations
Monitor project timelines and manage the financial components of Image QC within each study, which include collaboration with the study team on:
Identify potential study risks and mitigations, and escalate as appropriate.
Manage internal/external dialogue and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.
Use problem solving strategies to address client issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations.
OTHER DUTIES AND RESPONSIBILITIES:
Read, comprehend and be able to summarize various study documents (i.e. Clinical Protocol, contracting documents, budget, components of the Imaging Charter) to understand and communicate the role of imaging within the assigned studies.
Provide accurate and detailed project time reports, complete assignments within prescribed and committed timelines, seeking assistance and support when necessary.
Ensure compliance with timely training completion/documentation.
Contribute content for presentation at Investigator Meetings, site initiation or other meetings as needed.
Serve as a resource when assigned, to Business Development and/or Operational teams to present Imaging services and expertise, as needed and participate in sales initiatives to generate incremental revenue
Assist with training new members of the Imaging team when assigned.
Other related assignments, projects and tasks as assigned.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
Bachelor Degree and/or proven demonstrated skills or experience within the Imaging industry, including expertise in image acquisition, image quality and imaging workflows. Experience in lieu of degree will be considered. Active, in good standing certification or registry in one or more specific imaging modalities/areas is preferred.
Minimum 2-5 years of experience in imaging, project management and or project leadership experience with additional experience preferred in the workflows within one or more of: clinical trial management, healthcare management/operations, pre-clinical research, radiologic or a related science.
Excellent organizational, interpersonal, time management, and prioritization skills
Experience and demonstrated image quality assessment skills in two or more imaging modalities.
Must be computer literate with application knowledge of PACS, image analysis software, Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
Detail oriented and demonstrated responsiveness to inquiries and requests.
Understanding of risk management and the ability to identify potential problems, escalate and assist in resolution as needed.
Understanding of work in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
Excellent communication and organizational skills with a strong ability to collaborate (verbal and written) in English with teams of research scientists, bioinformaticians, software developers, and external collaborators. Will have interaction with clients, sites, management and staff.
Must have a valid passport and the ability to occasionally travel.
The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.
External Company Name: eResearch Technology