Quality Associate, Oncology Job at BillionToOne (Menlo Park)

Senior Clinical Research Operations Associate, Oncology

We are seeking a detail-oriented Senior Clinical Research Operations Associate t...

Location

United States , Menlo Park

Salary:

84480.00 - 95041.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a life science, public health, or related field with 2–3 years of hands-on clinical research coordination or clinical operations experience, or a Master’s degree (MPH or related) with 1–2 years of relevant clinical research experience
Working knowledge of IRB processes, informed consent, and Good Clinical Practice (GCP), with experience supporting submissions and ongoing study maintenance
Hands-on experience with clinical research database management (e.g., REDCap), including database build or maintenance, data entry oversight, and routine data quality review
Basic proficiency in SQL, and R or python for clinical data handling, including data cleaning, simple summaries, and generation of tables or figures for internal use
Strong organizational, communication, and project management skills, with the ability to manage multiple concurrent tasks, work collaboratively in a cross-functional environment, and execute independently under direction

Job Responsibility

Manage day-to-day operations for oncology clinical studies, including study timelines, task tracking, cross-functional coordination, study start-up and close-out activities, and preparation of internal status reports and study materials
Support regulatory and IRB activities under supervision, including preparation and submission of IRB applications, amendments, continuing reviews, protocol deviations, and maintenance of regulatory documentation in compliance with GCP
Develop, maintain, and monitor REDCap databases, including database build aligned to study protocols, routine data quality review, discrepancy tracking, and follow-up with study teams to ensure clean, analysis-ready datasets
Coordinate biospecimen, laboratory, and biobanking operations, including sample collection, shipment, accessioning, tracking, and collaboration with laboratory teams to build, curate, and maintain oncology specimen biobanking procedures and databases
Provide operational and analytical support for clinical data and scientific outputs, including preliminary data review, literature summaries, and assistance with internal analyses and development of scientific materials for presentations or publications

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

Clinical Research Associate - Oncology - Detroit

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Detroit

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
Eligible to work in United States without visa sponsorship
2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
Experience monitoring oncology clinical trials
Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
Clear communicator, problem-solver, and collaborative team player
Willing and able to travel up to 50% for on-site monitoring visits across Midwest region
Preference given to candidates residing in Detroit near major HUB airports

Job Responsibility

Serve as the primary point of contact between investigational sites and the sponsor
Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
Ensure site compliance with ICH-GCP, SOPs, and regulations
Maintain up-to-date documentation in CTMS and eTMF systems
Support and track site staff training and maintain compliance records
Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
Support subject recruitment and retention efforts at the site level
Oversee drug accountability and ensure proper storage, return, or destruction
Resolve data queries and drive timely, high-quality data entry
Document site progress and escalate risks or issues to the clinical team

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

New

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites
Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Partner with SCP and the study team to define and support recruitment initiatives at site level

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Research Associate 2, Oncology Research

Responsible for collecting, analyzing and interpreting collected data. The Resea...

Location

United States , Boca Raton

Salary:

58494.88 - 76043.34 USD / Year

Baptist Health

Expiration Date

Until further notice

Requirements

Masters degree of Science (minimum requirement)
CITI certification required within 30 days of hire
Highly organized with strong analytical, research, math and statistical skills
Previous experience working in an academic and/or scientific setting
Minimum Required Experience: 5 Years required
CITI: Biomedical Research, Good Clinical Practice & Conflict of Interest
Oncology research experience required

Job Responsibility

Responsible for collecting, analyzing and interpreting collected data
Adhere to Baptist Health South Florida (BHSF) guidelines when presenting research outcomes
Ensure that the highest quality of research is performed

Fulltime

Associate RWE Oncology Statistical Programming

Amgen is seeking a dedicated Associate Biostatistical Programmer to join our Cen...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least two (2) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Experience in statistical programming using SAS and SQL

Job Responsibility

Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
Provide technical solutions to programming problems within CfOR
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Manage all programming activities, according to agreed resource and timeline plans
Ensure all programming activities on the project adhere to departmental standards
Write and/or review and approve all programming plans
Write and/or review and approve analysis dataset specifications
Write, test, validate and execute department-, product- and protocol-level macros and utilities
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

Research Associate 3, Oncology Clinical Trials

Responsible for collecting, analyzing and interpreting collected data. The Resea...

Location

United States , Miami

Salary:

58494.88 - 76043.34 USD / Year

Baptist Health

Expiration Date

Until further notice

Requirements

Masters Degree is required
CITI certification required within 30 days of hire
Candidates must be highly organized with strong analytical, research, math and statistical skills
Previous experience working in an academic and/or scientific setting
Minimum Required Experience: 5 Years

Job Responsibility

Responsible for collecting, analyzing and interpreting collected data
Adhere to Baptist Health South Florida (BHSF) guidelines when presenting research outcomes
Ensure that the highest quality of research is performed

Fulltime

Business associate radiation oncology

Performs clerical duties in the technical work areas of the department. Supports...

Location

United States

Salary:

20.80 - 31.20 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High School diploma or equivalent
2 - 3 years of hospital registration, billing or collection experience
Knowledge of third party payors
Knowledge of the Allegra system preferred
Strong medical terminology background preferred, certification in medical terminology within one year of employment
Customer service experience preferred
Knowledge of a PC computer keyboard with data entry experience
Previous Allegra experience is beneficial
Excellent communication and customer service skills
Strong interpersonal skills

Job Responsibility

Performs clerical duties in the technical work areas of the department
Answers telephone in a timely manner, utilizing appropriate telephone etiquette
Greets and acknowledges patient and family members in a professional and welcoming manner
Coordinate incoming and outgoing calls including recording and reporting of pages and messages
Assists with “Call” report findings to physician/office
Participate in calling patients to confirm appointment times and or call-backs
Delivers completed requisitions/paperwork to technologist area in a timely manner
Assure that paperwork is filed and/or distributed according to policies and procedures in a timely manner
Accurately Complete 100% of paperwork in timely manner
Participate in trouble-shooting activites and implement corrective action plans as directed by manager

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

Parttime

Associate Vice President, Quality

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Thousand Oaks

Salary:

266028.00 - 359920.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 7 years of Clinical & Research Quality experience OR Master's degree and 10 years of Clinical Quality experience OR Bachelor's degree and 12 years of Clinical Quality experience AND 7 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Ensures proper quality oversight strategies of research activities and RBQM in clinical trials
Lead a global team and manage all trials across the Amgen portfolio globally
RDQ has a key role and responsibility in driving embedded quality partnerships across critical R&D programs
RDQ has a key role in advancing data driven oversight capability across the organization
Responsible for inspection readiness, inspection execution and follow up
Expanding our capabilities beyond GCP compliance and audit mindset focus include: Biosimilars, Rare Disease, Precision Medicine, Digital technology, Labelling, Product Complaint/Safety Reporting, PASS Study Management, Clinical trial simplification, Data analytics, Metrics development, R&D activities in response to regulatory trends and external pressures, Quality and compliance oversight over Amgen General Medicine: cardiovascular, obesity
Oncology, Inflammation and Biosimilar Portfolios
RDQ is transforming into an organization that provides quality assurance through proactive quality oversight in clinical trials on quality by design, critical to quality measures and risk-based quality assurance
Oversight of FSP and ensures performance of vendors is adequately executed for each study
Leads health authority inspection readiness and inspection strategy for clinical globally

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models where possible

Fulltime

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Quality Associate, Oncology

Job Description

Job Responsibility

Requirements

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