...Summary
The main function of a Precision Assembler is to performs assembly work utilizing lean principles (one-piece flow) to produce FDA regulated devices in a controlled work environment.
Job Description
Learn and carry out detailed work instructions...
Suggested
Full time
Contract work
Shift work
...to guide the quality systems for the Center and recommend changes to procedures that guide operations. Ensure procedures comply with FDA regulations and accrediting body standards as well as UT System policies and state regulations.
· Develop and business and...
Suggested
...aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies
~ Coordinate and schedule study procedures as per protocol.
~ Approved study protocols...
Suggested
Holiday work
Work from home
...Neurosurgery research team and Principal Investigators to assist in the preparation, submission, and regulatory/compliance guidance for FDA submissions, single-IRB management, and additional regulatory oversight as needed.
Experience and Education
Bachelor’...
Suggested
Full time
...aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies
# Coordinate and schedule study procedures as per protocol. Approved study protocols which...
Suggested
Full time
Traineeship
...Department of Internal Medicine, Division of Cardiology, seeks an Instructor with demonstrated potential to conduct studies on modifying FDA-approved drugs to induce myocardial regeneration through cardiomyocyte proliferation. These studies will also include in vitro and...
Suggested
Full time
...Assists with audits of technical functions.
Assists with preparation for inspections by regulatory bodies, including but not limited to FDA, AATB, EBAA, state health departments.
Assists with data gathering and facilities data review; prepares data records.
Performs...
Suggested
Holiday work
Work from home
Monday to Friday
...regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
Coordinates and schedules procedures as per research study.
A non-licensed coordinator...
Suggested
Local area
...other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents...
Suggested
...some form of regulatory experience, along with budget and contract experience. Knowledgeable about NIH grants, industry regulations, FDA auditing experience, project management and great communication skills is highly preferred.
Experience and Education
Bachelor’s...
Suggested
Full time
Contract work
...Duties
For campus-wide research, provide expert-level knowledge (application and interpretation) of federal regulations (DHHS, PHS, FDA, USDA, HIPAA, etc.), state regulations and policies, and institutional policies relevant to human or animal research and privacy....
Suggested
Holiday work
Work from home
...studies the following tasks.
Perform review of research protocols, informed consent documents, contracts, Notices of Grant Award, FDA letters, and other research documents to develop clinical trial budgets and comprehensive Coverage Analyses.
Analyze Medicare benefit...
Suggested
Holiday work
Work from home
...functional areas, tissue processors and agencies as needed.
Maintains current knowledge of applicable TSC standard operating procedures, FDA regulations, AATB Standards, and EBAA Medical Standards.
Assists with contract management for referral facilities.
Ensures...
Suggested
Contract work
...overseeing investigator-initiated clinical research and working knowledge of research Good Clinical Practices, Federal Drug Administration (FDA), and Office of Human Research Protections (OHRP) guidelines. This position is eligible for remote work schedule.
Experience and...
Suggested
Traineeship
Local area
Remote job
...accuracy of research data required for studies.
~ Coordinates all regulatory aspects, such as preparing safety reports, adverse events, FDA compliance, drug company monitoring, laboratory standards; and laboratory standards; maintains databases related to these regulatory...
Suggested
Local area
...other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents...
...regulatory documents to submit to the Central IRB and oversee required submissions to the Clinical Coordinating Center (CCC), DSMB, FDA, and IRB, as required.
Ensure Lead Node Regulatory collects all required documentation (e.g., reliance agreements) from sites....
Interim role
Local area
Remote job
...team members.
Knowledge of regulatory standards and compliance requirements related to product design and development (e.g., ISO, FDA regulations) is desirable.
Creative thinker with a passion for innovation and problem-solving.
Education and Experience:
~ Bachelor...
Local area
