CRA I Job at iconplc (Kuala Lumpur)

Cra I

As a CRA I at ICON, you will contribute to our clinical trial operations functio...

Location

Israel , Tel Aviv

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent
Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
Excellent written and verbal communication in English
Good social skills enabling you to deal with queries in a timely manner
Willingness to travel as required (approximately 60%)

Job Responsibility

Delivering clinical trial monitoring work to a high standard, working closely with team and stakeholders
Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
Running sponsor generated queries efficiently and taking responsibility for study cost efficiency
participate in the preparation and review of study documentation and feasibility studies for new proposals as required
Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff
Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and 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

CRA I

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

Location

Canada , Burlington

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
BA/BS/BSc in the sciences or nursing equivalent
A trained CRA with on-site monitoring experience
Comprehensive knowledge and understanding of ICH-GCP
Fluent oral (face to face and telephone) and written English language skills
Able and willing to travel up to 60% of the time or as per local requirements
Possession of a full driver’s license

Job Responsibility

Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
Operational Excellence: Contribute to sponsor goals
Promote operational and scientific excellence
Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness
Building and maintaining solid and professional relationships with site staff
Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
Maintaining site audit/inspection readiness
Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan

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 - Oncology - East Coast ICON plc is a world-...

Location

United States , New York; Georgia; New Jersey; Boston; Philadelphia

Salary:

110520.00 - 138150.00 USD / Year

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
Atleast 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
Bonus, stock compensation and commissions in some cases depending on your role and performance

Fulltime

Interim Compliance Manager / Officer

A regional banking institution is seeking an Interim Compliance Manager / Office...

Location

United States , Basehor

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Prior experience in bank regulatory compliance, BSA/AML, and/or CRA
Demonstrated experience supporting or remediating OCC exam findings
Familiarity with Verafin or similar AML/compliance platforms strongly preferred
Strong documentation, organizational, and execution skills
Ability to work independently, manage priorities, and meet regulatory deadlines
Experience within community or regional banks preferred

Job Responsibility

Assist with remediation of a backlog of BSA customer reviews, with emphasis on high-risk, high-dollar clients from the prior year
Input, update, and validate customer and risk data within the bank's newly implemented Verafin system
Ensure completeness, accuracy, and audit-ready documentation across BSA client profiles
Review recent OCC findings and recommend interim compliance controls
Implement control enhancements to address gaps identified by regulators
Support management in preparing for the next OCC examination within 4–6 months
Build out and document current CRA processes and internal controls
Ensure CRA activities and controls are properly logged and supported in the client CRA workbook
Prepare documentation and materials for the June CRA review
Provide ad hoc clerical and operational support for audit and compliance initiatives as needed

What we offer

Medical, vision, dental, and life and disability insurance
401(k) plan

Fulltime

Clinical Research Associate

CRA I - Oncology - sponsor dedicated - Israel. ICON plc is a world-leading healt...

Location

Israel , Tel Aviv

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent
Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
Excellent written and verbal communication in Hebrew & English
Good social skills enabling you to deal with queries in a timely manner
Willingness to travel as required (approximately 60%)

Job Responsibility

Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
Running sponsor generated queries efficiently and taking responsibility for study cost efficiency
you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required
Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff
Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and 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 - 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

Clinical Project Manager III

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelo...

Location

United States , Bedford

Salary:

135000.00 - 155000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Medical Technologist degree or BS in STEM is preferred
Minimum of 4 years experience in clinical project or research management
Minimum of 2 years' experience leading CRAs
Experience in design and development of medical instrumentation
Clinical Research Associate (CRA) certification or equivalent certification in project management is desired
Working knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Administration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
Problem solving, conflict management, listening, managing and measuring work
Strong project management skill set and familiarity with project management tools and techniques
Team player, self-motivated, perseverance

Job Responsibility

Provide technical and team leadership to one or more small clinical project team(s), including planning, scheduling, and technical leadership within the project area. Coordinate roles and responsibilities within the clinical project team
Responsible for clinical project planning and scheduling, utilizing deliverable milestone methods and critical path scheduling, and developing task and project estimates. At the Program Manager's, Clinical Research managers, or Clinical Director's request provide a schedule and budget forecast for the project
Responsible for conducting regular clinical project team status meetings and reviews. Plan and schedule technical reviews at appropriate clinical project milestones. Ensures deliverables are completed and documented according to Good Clinical Practice and per design control
Responsible for coordination of clinical project resources to identify the root cause(s) of clinical project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. If needed, coordinate with cross-functional team resources to support root cause initiatives
Responsible for insuring clinical project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are developed and executed. Track and respond to risk triggers. Regularly assess and report the status of overall clinical project risk to the development project team and Clinical Research Manager
Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy
Responsible for communication within clinical project team, development project team, and to clinical program management and department management. Develop and implement a project communication plan
Coordinates with study sites and internal service suppliers (i.e., Biobanking, Field Service Engineers, etc.) to ensure project deliverables are completed correctly and on time or that services are provided in accordance with the project plan
Able to identify and obtain support to resolve project team conflict. As necessary, work with development project leader to resolve cross-team conflicts. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the multi-disciplinary clinical project team members
Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures

What we offer

medical insurance
dental insurance
vision insurance
401k plan retirement benefits with an employer match
paid vacation
paid sick leave

Fulltime

CRA II and Senior CRA

CRA II and Senior CRA - Remote - Brazil. ICON plc is a world-leading healthcare ...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Complete Bachelor's degree in a scientific or healthcare-related field
MUST have previous experience as a Clinical Research Associate - Monitor de Pesquisa onsite (Performing Independent onsite monitoring visits - SIV, Routine, Close Out)
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Ability to travel at least 70% of the time (international and domestic - fly and drive) and should possess a valid driver's license
MUST have advanced English Communication, Writing and Reading

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

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

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CRA I

Cra I

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