Careers

RESPONSIBILITIES & ACCOUNTABILITIES

• Operates within the project and department parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
• Provides administrative support to the clinical operations department and project teams.
• Administratively assists with project activities, ensures protocol adherence and addresses non-compliance issues, as appropriate.  Assists with coordination of training sessions, webinars, meetings and/or programs, as needed and upon request.
• May assist with communication with clinical sites to coordinate personnel training and equipment credentialing, as needed.
• Assists with maintenance of clinical trial records (electronic and hardcopy files).
• Assists with the coordination of internal, sponsor and other meetings, as needed and upon request.
• May assist with the writing of controlled documentation.
• Participates in internal and external project-related audits and audit-related activities.
• Provides support for all clinical operations related activity.
• Performs other departmental activities as needed and upon request.

EDUCATION & EXPERIENCE

• Undergraduate degree or certificate in science, business or related field, preferred.
• At least 1 year of clinical trial experience, preferred.
• Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
• Excellent written and oral communication skills.
• Excellent organizational skills and attention to detail.
• Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities

Engineer Manager sought by MedQIA LLC in Los Angeles, CA.

Duties: Develop clinical trial and clinical services software following agile processes and ensuring on-time delivery per agreed upon schedule. Develop, support and maintain company’s clinical trial and clinical service information systems, internal software applications, and associated IT infrastructure. Designs, develop and validate medical imaging software tools, including validation plan and test scripts to verify that software meets requirement specifications including associated regulations. Generate documentation concerning structure and integrity of the medical information system and database as applicable. Train personnel on the use of developed software applications. Provide ongoing maintenance of validated clinical trial and clinical service information systems and quantitative medical imaging software tools. Troubleshoot IT and software-related issues. Provide technical client support as needed. Write procedure documentation related to usage and maintenance of clinical trial and clinical service software. Perform other departmental and study-related activities as needed and upon request.

Send Resumes to:
Detra Cranfield,
MedQIA, LLC. 10850 Wilshire Blvd., Suite 1170
Los Angeles, CA 90024

Requirements: Bachelor’s degree or foreign equivalent degree in Computer Science, Computer Engineering, or related field, plus four (4) years of experience as a Software Engineer, or related experience in Clinical Trials or Clinical Services space. Must have experience in: data processing pipelines for high volume and high throughput big data medical imaging data sets; working with clinical trials or clinical services PACS system; Java, C#.NET, Python, PHP, and MVC; RESTful API and general service-oriented architectures; DICOM, HL7 and PACS; working knowledge of Medical Imaging modalities; Agile frameworks; developing real time image processing and computer vision systems to run on CPU and GPU hybrid environments; architecting, developing, and maintaining large scale distributed systems with cloud infrastructure services (AWS) and containerization (Docker); image data, unstructured data, MongoDB, PostgreSQL and Redis; and messaging and distributed streaming platforms (RabbitMQ).

ROLE

Quality Assurance (QA) Specialist

DEPARTMENT

QA & Regulatory Compliance

DESCRIPTION

Performs QA activities in assigned areas per the Quality Management System (QMS).

REPORTS TO

Director of Quality

RESPONSIBILITIES & ACCOUNTABILITIES

• Audit activities, including planning, conduct, response, and documentation
• Quality issues, complaints, nonconformities and Corrective and Preventive Actions (CAPA)
• Vendor/ supplier qualifications
• Quality management review
• QA and regulatory compliance reviews of documentation
• Periodic review of controlled documentation, and assessments of internal files
• Performs document control activities, including quality record maintenance
• Performs activities related to personnel training and maintenance of training documentation
• Involved in administration and overall maintenance of the company’s eQMS
• Contributes to development, review and revision of procedures in accordance with the QMS
• Assist with regulatory submissions related to the proprietary medical device software
• Participates in QA-related meetings: scheduling, agenda, minutes and action item management
• Provides QA and regulatory compliance guidance and feedback cross-departmentally
• Reports quality aspects to departmental Lead or Officers as part of management review
• Performs other departmental activities as needed and upon request

EDUCATION & EXPERIENCE

• Requires undergraduate degree and at least 3 years of experience in activities related to quality, or an acceptable combination of education and experience
• Experience in medical device, pharmaceutical and/or biotech clinical research industry a must
• Working knowledge of regulations, standards and guidelines related to quality in clinical trials
• Experience in regulatory submission activities for medical devices preferred
• Knowledge on eQMS a plus
• Excellent written and oral communication, attention to detail, organizational and planning skills
• Ability to perform and maintain quality work while prioritizing and managing multiple deadlines
• Ability to work with different departmental designees on quality-related activities
• MedQIA will continue to monitor our workplace and add safety measures based on guidance from the Centers for Disease Control and Prevention (CDC) and other government organizations to reduce the risk and prevent the spread of Covid-19