Research Associate 3, Oncology Clinical Trials Job at Baptist Health (Miami)

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

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

New

Research Associate 3, Neuro Medical Oncology

The Research Associate III at Baptist Health is a pivotal role focused on collec...

Location

United States , Miami

Salary:

58494.88 - 76043.34 USD / Year

Baptist Health

Expiration Date

Until further notice

Requirements

Masters
CITI certification required within 30 days of hire
While a Master's degree of Science is a minimum requirement, candidates with PhD and MD degrees (especially those who completed their residency programs) are preferred
Candidates must be highly organized with strong analytical, research, math and statistical skills as well has had 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
The Research Associate 3 will adhere to Baptist Health South Florida (BHSF) guidelines when presenting research outcomes and ensure that the highest quality of research is performed

What we offer

Career growth and development opportunities, with clear pathways and ongoing support
Comprehensive health and wellness resources that go beyond traditional benefits
A wellness program that can help employees eliminate their medical plan deductible, reducing out-of-pocket healthcare costs
Tuition reimbursement to support continued learning and advancement

Fulltime

Senior Clinical Research Associate

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

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
3 years of monitoring clinical trials
At least 1 year of oncology monitoring experience
Phase I/II solid tumor: gastro, colorectal, breast, head and neck experience highly preferred
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Located on the East coast near major hub
Willingness to travel as required (approximately 60%)

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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 Associate

Senior Clinical Research Associate - Home-Based (CANADA). ICON plc is a world-le...

Location

Canada , Montreal; Toronto; Vancouver; Burlington; British Columbia; New Brunswick; Quebec

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree, or its international equivalent in a scientific or health-related field or an equivalent combination of education and clinical research experience, particularly in a study coordinator or nursing role
1+ years of clinical monitoring experience or equivalent combination of education and experience is required for the level 2 role
3+ years is required for a level 3
Ability to travel 70%
Knowledge of ICH and local regulatory authority regulations regarding drug trials
Applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements

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 Associate - Midwest/Central US - 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

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
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

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
During study conduct, 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
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)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes
Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines

Fulltime

Senior Clinical Research Associate - FSP

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

Location

South Korea

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)
Fluent in English and in the native language(s) of the country they will work in
Extensive knowledge of clinical trial methodologies, ICH/GCP and local country regulations
Global clinical trial experience
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Demonstrated knowledge of clinical research and development processes
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research
Demonstrated knowledge in disease and technical areas pertaining to clinical studies
Demonstrated ability to support sponsor regulatory interactions/inspections

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client 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
Partner with SCP to perform investigator site development, coaching and training of site personnel
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)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

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

Fulltime

Senior Clinical Research Associate

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

Location

Argentina

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
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
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

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client 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
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
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, to bring SAE reports required information to resolution

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

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Research Associate 3, Oncology Clinical Trials

Job Description

Job Responsibility

Requirements

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