Clinical Research Associate - Oncology Job at iconplc (Multiple US Locations)

Clinical Research Associate II/Sr. Clinical Research Associate - 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

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner 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
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed

What we offer

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

Clinical Research Associate II/Senior Clinical Research Associate

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)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel
Attend investigator meeting when required
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

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

Clinical Research Associate/Senior Clinical Research Associate

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

Location

United States , Midwest, West region

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process
Good understanding of Clinical Study Management including monitoring, study drug handling and data management
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Ability to travel nationally/internationally as required
Valid driving license per country requirements, as applicable
Oncology Experience required
Proficient in written and spoken English language required

Job Responsibility

Contributes to the selection of potential investigators
Accountable for study start-up and regulatory maintenance (in some countries)
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed required training
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Updates CTMS and other systems
Manages study supplies, drug supplies and drug accountability

What we offer

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

Fulltime

Clinical Research Associate/Senior Clinical Research Associate- FSP

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

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process
Good understanding of Clinical Study Management including monitoring, study drug handling and data management
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills

Job Responsibility

Contributes to the selection of potential investigators
As required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Updates CTMS and other systems with data from study sites
Manages study supplies, drug supplies and drug accountability at study site

What we offer

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

Senior Clinical Research Associate (Oncology Experience Required)

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Minimum of 5 years' experience in CRO or Pharma trials environments
Experience in oncology trials and RECIST criteria is essential
Fluency in English is required
Proficiency in local language is required
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders

Job Responsibility

Ensuring regulatory, ICH-GCP and protocol compliance
Verifying the process of obtaining informed consent
Assessing factors that might affect subject safety and clinical data integrity
Conducting monitoring activities using different methods (e.g., on site and remote)
Conducting source document review and verification
Managing reporting of protocol deviations
Applying query resolution techniques
Performing Investigational Product (IP) inventory, reconciliation and review
Verifying IP dispensation and administration
Managing reporting of identified issues

Senior Clinical Research Associate (Oncology Experience Required) - UK (Remote) - FSP

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in oncology trials and RECIST criteria is essential
Minimum of 4 years' experience in CRO or Pharma trials environments is also essential
Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders
Proficiency in local language is required
Fluency in English is required

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensuring regulatory, ICH-GCP and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
immediately communicates/escalates significant issues to the project team and develops action plans
Verifies the process of obtaining informed consent has been adequately performed and documented
Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity
Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
Conducts source document review and verification of appropriate site source documents and medical records
Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
Manages reporting of protocol deviations and appropriate follow up

What we offer

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

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

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

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Clinical Research Associate - Oncology

Job Description

Job Responsibility

Requirements

What we offer

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