CRA I Job at iconplc (Burlington)

Associate principal specialist

Lead impactful patient safety initiatives in a dynamic, global pharmaceutical en...

Location

Japan , Tokyo, Osaka

Salary:

12000000.00 - 18000000.00 JPY / Year

Randstad

Expiration Date

February 16, 2026

Requirements

Qualified degree in Pharmacy, Medical Sciences, or a related field
Understanding of relevant regulations (e.g., PMD Act, GCP/GVP/GPSP)
Basic knowledge of statistical analysis
Expertise in medical/pharmaceutical science
Experience with process improvement methodologies (e.g., 6 sigma)
Excellent communication and negotiation skills (verbal and written)
Business-level English proficiency (for communication with global teams)
Proven ability to influence decisions and build credibility in complex situations
Coaching and mentoring experience
Project management skills

Job Responsibility

Lead impactful patient safety initiatives in a dynamic, global pharmaceutical environment
Oversee and manage patient safety-related processes, activities, and issues at the country level
Provide expert advice and support on patient safety processes and strategy
Analyze data and identify trends to mitigate patient safety risks
Support the development and implementation of patient safety processes and strategies
Contribute to significant decisions and projects on a multi-country or local level
Lead small projects or specific segments of larger international projects
Potentially manage junior team members (Matrix Manager)

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

Clinical Research Associate

Proclinical is seeking two Clinical Research Associates to join our client on a ...

Location

United Kingdom , City of London

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Experience in Clinical research, preferably within a CRO or pharmaceutical setting
Previous history of independent monitoring experience is required
Background in diabetes or obesity therapeutic areas is beneficial but not essential
Strong organizational and communication skills
Capacity to travel regionally as the business requires
Academic candidates with relevant experience, including monitoring, will also be considered

Job Responsibility

Conduct site visits within the select region
Perform monitoring activities to ensure adherence to compliance standards with study protocols, regulatory requirements, and GCP
Work closely with site staff to ensure proper documentation and data collection
Support study start-up, maintenance, and close-out activities
Maintain effective communication with study teams and stakeholders
Provide updates and reports on site performance and study progress

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Team Leader - Global Compliance

We are seeking a dedicated and experienced Compliance professional to join our g...

Location

India , Bangalore

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

A post-secondary degree or diploma in Law, Business Administration, Finance, or a related field
5 - 15 years of experience leading a compliance function within a global organization
Strong knowledge of global compliance frameworks and regulations (e.g., FCPA, Modern Slavery legislation, ESG, CBAM, AI laws, EU-CRA, GDPR, SOX, CSRD)
Experience conducting compliance risk assessments and implementing risk mitigation methodologies
Knowledge of regulatory and industry best practices relevant to the business and the compliance function
Critical thinker with strong decision-making skills
Excellent written, communication, and presentation skills with the ability to influence and train diverse teams
Superior organization skills with the ability to pivot as requirements, deadline, or priorities change
Strong analytical skills with attention to detail and the ability to interpret complex regulatory requirements, and recommend solutions to complex control, financial, or technical issues
Proficiency in managing compliance technology tools and reporting systems

Job Responsibility

Support the development, implementation, and maintenance of the global compliance program, ensuring alignment with applicable laws, regulations, and industry standards in all areas including International Trade (export controls and sanctions
anti-bribery and anti-corruption), Data Protection, Sustainability, Ethics, and Code of Conduct compliance
Create and maintain a tracking system of compliance requirements that apply to the organization with a schedule of changes, date of effect and the date by which ATS entities need to demonstrate compliance
Maintain a schedule of global policies, review schedule and work with policy owners for timely review and updates as required
Monitor and interpret global regulatory developments and assess their impact on the organization
Assist in creating compliance training content and best practices libraries
Collaborate with cross-functional teams, including Legal, Human Resources, IT, Operations for data mapping activities and any follow up actions that results from the review
Provide consolidated analytics, report and maintain dashboards for KCIs (Key Compliance Indicators) & KRIs (Key Risk Indicators)
Oversee equipment/ spares classification across the organization and support compliance specialists in performing the classification
Provide support for digital transformation of compliance activities and new methods to leverage technology

Seasonal French Bilingual Tax Expert

Ready for a new seasonal opportunity with the #1 tax software company in Canada?...

Location

Canada

Salary:

24.50 - 33.50 CAD / Hour

Intuit

Expiration Date

Until further notice

Requirements

Minimum of 2+ years of paid professional tax preparation experience
Must provide CRA RepID (representative identifier) upon successful onboarding
Experience utilizing professional tax software to prepare and file personal tax returns, including those with complex elements such as employment, self-employment, rental income, investments, T1135 forms, foreign income, and various credits and deductions
Passionate about helping clients navigate the complexities of taxation
Excellent customer service skills
Willing and available to work a flexible schedule with a minimum of 20 hours per week
Proficiency in both English and French
Tax Expertise - Demonstrates a fundamental understanding of tax laws and concepts
Effective Communication - Uses written and verbal communication skills to provide quality service
Complex Problem Solving - Demonstrates commitment to understanding customer problems

Job Responsibility

Help customers complete their taxes using Intuit TurboTax products
Provide tax guidance and review personal tax returns for customers completing their tax return on their own
Full service return preparation
Manage product/software inquiries
Utilize government websites, professional resources, and team expertise to seek out and deliver the right answer to the customer
Use state of the art video communication software to interact with customers
Document interactions to maintain accurate records

What we offer

Employee Assistance Program
Product discounts and free copy of TurboTax Live
Free equipment for virtual offices
Flexible scheduling options
Employee stock purchase plan
Paid time off
Eligible for a cash bonus, equity rewards and benefits

Parttime

Compliance Risk Assessment Officer

Reporting to the Head of Compliance Risk Assessment within the Transversal Compl...

Location

United States Of America , NEW YORK

Salary:

140000.00 - 180000.00 USD / Year

Crédit Agricole

Expiration Date

Until further notice

Requirements

Bachelor Degree / BSc Degree or equivalent
BBA or Accounting Degree
11 years and more experience
Experience conducting a Compliance Risk Assessment or RCSA exercises
Prior Compliance, Risk or Internal Audit experience within a Corporate Bank environment
Knowledge of Banking regulatory rules for FRB, DFS, etc. as applicable
Analytical skills to understand risk rating scoring
Strong interpersonal and presentation skills with the ability to articulate complex problems and solutions through concise and clear messaging
ability to influence and lead at a senior level
Ability to collaborate with cross functional partners across the three lines of defense

Job Responsibility

Design and continuously improve the Compliance Risk Assessment (CRA) methodology
Execute the annual CRA exercise across Bank businesses and Support Functions
Manage comprehensive data collection processes and implement quality controls
Provide credible challenge to first line of defense (LoD1) CRA results
Develop insightful management presentations on CRA framework and results
Create regular compliance reports highlighting key metrics, risks, and controls
Design and maintain data analytics dashboards to visualize compliance trends
Analyze CRA results and prepare comprehensive reports for stakeholders
Assist in managing the Risk and Control Self Assessment (RCSA) process
Develop and maintain risk mapping for the Compliance Function

Fulltime

Clinical Monitoring Manager

We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs ...

Location

United States

Salary:

150000.00 - 170000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry
Minimum 2 years of experience leading a team of CRAs
Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus
Certification as a Clinical Research Associate (CCRA) or equivalent preferred
Recent experience working on trials utilizing risk-based monitoring models
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Strong understanding of clinical trial processes and study conduct

Job Responsibility

Oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials
Serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites
Accountable for oversight of clinical monitoring activities from site identification through close out of the study site
Responsible for the study deliverables of in-house CRAs on a given study(s)
May be responsible for the hiring of in-house CRAs
Input into and assist with the development of study documents
Oversee development and implementation of project specific processes, tools, and documents
Support the training and development of in-house CRAs
Oversight of review of monitoring visit reports and metrics
Responsible for oversight of CRA review of clinical data

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Clinical Site Associate (In-House CRA)

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

Location

Turkey , Ankara

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, such as life sciences or healthcare
Previous experience in clinical research or a related field preferred
Strong organizational and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Attention to detail and ability to prioritize tasks effectively
Fluent in English and local language, with good verbal and written communication skills

Job Responsibility

Site Support & Oversight: Manage site-level communications, coordinate site trainings and systems access, and support site readiness activities including pre/post site visit tasks, and follow-up on action items
Document Management: Maintain Trial Master File (TMF) and Investigator Site File (ISF) accuracy and inspection readiness
perform quality control, filing, and tracking of essential documents in partnership with CTM, CRAs and TMF Lead as applicable
Data & System Management: Support subject tracking, data entry oversight, and system maintenance in CTMS and eTMF
assist with eCRF UAT testing and clinical sample tracking
Compliance & Audit Readiness: Prepare for and support audits/inspections, support CAPA implementation, and ensure adherence to protocol, GCP, and regulatory requirements
Monitoring & Issue Resolution: Ensure data entry timeliness, speedy query resolution, support CRA’s with protocol deviations follow-ups, and site escalations
support SAE and external data submissions and follow up
Site Relationship Management: Support the CRA in establishing and maintaining strong site relationships. CSA needs to understand site-specific processes, and act as a back-up point of contact for the CRA
or as a primary point of contact when needed

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

iconplc

Location:
Canada , Burlington

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 01, 2026

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CRA I

iconplc

Location:Canada , Burlington

Category:IT - Administration

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:February 01, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for CRA I

Associate principal specialist

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Location:
Canada , Burlington

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Contract Type:
Not provided

Job Posted:
February 01, 2026