Researcher, Safety Oversight Job at OpenAI (San Francisco)

Manager Environmental Research Safety

Location

United States , Winston Salem

Salary:

51.05 - 76.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor's degree required, Safety Management, Safety Engineering, Occupational Safety & Health, Industrial Hygiene, Environmental Management, Risk Management, Regulatory Compliance or related degree or equivalent experience
5 years of related field experience
Familiarity with regulatory agency code requirements, and the progressive application of these standards, including, “Physical Environment” NFPA 101 Life Safety Code, National Institute of Health, Biosafety in Microbiological and Biomedical Laboratories, EPA, and OSHA requirements for General and Construction Industries preferred
Must have the ability to clearly communicate verbally, in person, and in writing with patients, families/agencies and the health care team
Must possess a strong sense of urgency and make sound decisions
Must be a critical thinker, have ability to solve problems, and is solution oriented
Intermediate to advanced computer skills with demonstration of skill and competence in use of all Microsoft Office applications required
This position requires travel, therefore, will be exposed to weather and road conditions
Operates all equipment necessary to perform the job
Must be able to carry up to 25 pounds of material and various types of equipment

Job Responsibility

Provides leadership oversight for Academic Research Safety, Environmental Compliance, and Physical Environment to ensure regional and institution strategic compliance
Manage Research administration to include, regulatory compliance, Industrial Hygiene, Biosafety, cultivate industry relationships, research ethics, sponsored programs, research coordination and research innovation throughout the region to execute high-priority projects while developing and maintaining exceptional research platform
Manage daily operations of the Research Environmental Health and Safety team
Directs team to implement, coordinate, and present educational opportunities on research safety, select agents, export control, biosafety, infection control, animal research-related environmental and occupation health, emergency management and environmental, safety and health matters
Manage development and implementation of general and specialized research safety programs, audits and surveys to identify, measure, and evaluate known and potential hazards and risks
Coordinates actions among laboratories, departments and facilities to implement corrective actions, as needed
Researches, analyzes and interprets NIH, DoD, NSF, USDA, OSHA, EPA, Homeland Security, and other regulations addressing research safety including zoonosis and environmental, health & safety issues such as hazardous materials & waste, biological and laboratory safety, PPE, etc
Directs and interacts with regulatory agency personnel during compliance inspections for research
Understands and shares technical expertise with others, including leaders, peers, and teammates and utilizes problem solving skills for complex situations that arise
Serves as the technical resource and subject matter expert

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Clin Research Reg Spt Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Fully adheres to applicable safety and/or infection control standards required
Understands and follows data integrity standards and processes required
Ability to effectively manage a higher volume of protocols preferred
Ability to effectively manage moderately complex research protocols/procedures preferred
Possesses a high degree of self-motivation preferred
Recognized ability to function independently preferred
Proficient in managing multiple and competing priorities/demands preferred
Detailed-oriented in record keeping and research documentation preferred

Job Responsibility

Responsible for the coordination and oversight of regulatory requirements of clinical research protocols
Develops increased learned skills, flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols under the direction of the Principal Investigator (PI) and senior leaders
Prepares all regulatory documentation, document filing, tracking, and maintenance
Maintains all logs, including OnCore, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs)
Collects all regulatory documents required to submit to the DWG and PRMC and collates essential regulatory documents within Complion
Prepares/drafts ICF and insert institutional language, ensuring language is consistent with protocol
Enters and loads all required documents to OnCore and Complion
Coordinates and validates the delegation log with the applicable DWG clinical research staff
Prepares and tracks submission to Institutional Review Board (IRB) (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc
Maintains regulatory records and necessary correspondence records

Fulltime

Extension Associate

This position provides leadership in the development, implementation, and evalua...

Location

United States , Manhattan

Salary:

61591.00 - 81000.00 USD / Year

Kansas State University

Expiration Date

June 07, 2026

Requirements

Bachelor's degree
Three years of relevant experience
Valid driver's license

Job Responsibility

Provides leadership in the development, implementation, and evaluation of research-based food safety extension programming, training, and outreach initiatives
Collaborates with faculty, staff, and stakeholders to translate applied research findings into practical education programs and technical resources
Directs the management, compliance, and operational oversight of the Kansas Value Added Foods Lab (KVAFL), supporting applied research, product development, and industry engagement activities

What we offer

Health and life insurance
Retirement plans
Generous paid time off

Fulltime

Sr Clinical Research Data Specialist

Works in partnership with the primary point of contact to provide high quality, ...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree Required
2 years of relevant experience Required
or equivalent combination of education and experience Required
Skill in completing assignments accurately and with attention to detail Required
Ability to understand and follow standard research protocols and procedures Required
Ability to process and handle confidential information with discretion Required
Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
Commitment to the University’s core values Required
Ability to work independently and/or in a collaborative environment Required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required

Job Responsibility

Assists in conducting quality checks of data accuracy with data source records as assigned
Perform data entry and verification tasks
Provides custom programming, statistical analysis, reporting and presentation graphics
Prepare and transfer data for analysis
Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics
Adheres to defined application development life-cycle practices
Consults with user departments and sites to assess data preparation and management needs, program design and testing
package selection and use of systems, software and equipment
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately
Answers a broad range of data clarifications for each study

Parttime

Clin Research Data Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

23.06 - 32.29 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Skill in completing assignments accurately and with attention to detail required
Ability to understand and follow standard research protocols and procedures required
Ability to process and handle confidential information with discretion required
Commitment to the University’s core values required
Ability to work independently and/or in a collaborative environment required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
Strong interpersonal, communication, and organizational skills required
Highly collaborative, works well in teams required

Job Responsibility

Assumes responsibility for the data management of clinical research protocols
Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed
Formulates and organizes data entry plans to manage assigned caseloads
Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting
Assists in conducting quality checks for data accuracy with data source records as assigned
Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment
Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately
Manages a workload of studies commensurate to level of experience
Answers data clarifications for each study
Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit

Fulltime

Clin Research Data Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

23.06 - 32.29 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Skill in completing assignments accurately and with attention to detail required
Ability to understand and follow standard research protocols and procedures required
Ability to process and handle confidential information with discretion required
Commitment to the University’s core values required
Ability to work independently and/or in a collaborative environment required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
Strong interpersonal, communication, and organizational skills required
Highly collaborative, works well in teams required

Job Responsibility

Assumes responsibility for the data management of clinical research protocols
Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed
Formulates and organizes data entry plans to manage assigned caseloads
Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting
Assists in conducting quality checks for data accuracy with data source records as assigned
Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment
Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately
Manages a workload of studies commensurate to level of experience
Answers data clarifications for each study
Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit

Fulltime

Drug Safety Associate

Drug Safety Associate -Pharmacovigilance Role-Home Based-South Korea-ICON Strate...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

1 year or 1.5 years experience of related experience
Undergraduate degree or its international equivalent, preferably in life science, Nursing, Pharmacy and/or healthcare professional
Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities

Job Responsibility

Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, patient oriented programs, literature, spontaneous reports, etc
Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality
Manage reporting/submission/distribution of safety reports/updates/information(e.g. SAE, SR, SUSAR, PSUR, DSUR..etc) to local health authorities and/or clinical operations in cooperation with other clinical operation team
Provides technical and process oversight with respect to safety services for larger full service projects or smaller safety stand-alone projects
Ensures quality and consistency across multiple projects for one client
Supports the SRM management team in the development of training courses as well as SOPs and associated documents
Participates in the Safety and Risk Management Regulatory Intelligence activities, to retrieve and maintain a global repository of regulatory safety reporting requirements
개별 사례안전보고서 (수신된 ICSR추적, 회사 또는 고객 안전 DB에 입력, 쿼리 관리)
통합안전보고서 생성지원 (약물별 정기 보고 support)
클라이언트의 라이센스 파트너에게 안전 보고서 제출

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Principal Physician, Patient Safety

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Expertise in drug safety and the drug development process
Demonstrated success in technical proficiency and scientific creativity
Ability to work on complex problems requiring in-depth evaluation
Ability to exercise judgment within broadly defined practices and policies
Good presentation and verbal/written communication skills
Good interpersonal skills
Client focused approach to work
Demonstrated ability to balance technical expert responsibilities with people management duties when assigned
Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Communicating and discussing issues related to review process with Line Manager/Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections, Act as a Subject Matter Expert during Audits/inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

Fulltime

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Researcher, Safety Oversight

Job Description

Job Responsibility

Requirements

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