Study Start Up CRA Job at iconplc (Buenos Aires)

CRA, Study Start-up and Maintenance

Specializing in oncology, Kapadi excels at navigating the early stages of drug d...

Location

Poland , Cała Polska

Salary:

Not provided

GRUPA NEUCA

Expiration Date

Until further notice

Requirements

proven 5+ years of experience in study start-up processes in clinical research
a medical-related university degree
working knowledge of ICH-GCP and local regulatory guidelines
strong communication, organizational, and multitasking skills

Job Responsibility

site and project coordination: act as the main point of contact for clinical sites throughout the study lifecycle, providing support for site initiation, compliance, and regulatory documentation
documentation & tracking: maintain and update project documentation, tracking activities, site status, and action items according to SOPs
regulatory maintenance: oversee regulatory updates, including protocol amendments, safety reports, and IRB/IEC submissions, ensuring all documentation is current and compliant
training & compliance: complete required training and keep up-to-date with ICH-GCP guidelines and relevant local regulations
budget and contract: oversight and liaison between site and sponsor with budget and contracts

What we offer

remote work opportunities
professional development in a well‑established company with a strong market position
employment in a company awarded the Top Employer 2026 certificate – we create a work environment based on trust, collaboration, and diversity
a comprehensive benefits package in the form of a cafeteria system – you decide which benefits best suit your needs
Private medical care
Free legal advice
Social benefits
Employee referral program
Day off on birthday
Life insurance

New

Senior Clinical Trial Manager

As a Senior Clinical Trial Manager at ICON, you will manage clinical trial opera...

Location

Australia , Sydney

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 6+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization (in addition to CRA experience)
Bachelor's degree in health, life sciences, or other relevant fields of study
At least 10+ years of relevant experience in clinical trial management.

Job Responsibility

Budget Oversight
Ensuring Effective Study Oversight
Optimizing Performance
Timely Study Start-Up & Enrollment
Improving Study Integrity
Building Productive Relationships.

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

In-house Sr Clinical Research Associate

A clinical-stage biopharmaceutical company in San Diego, California is seeking a...

Location

United States , San Diego

Salary:

60.00 - 75.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor degree preferred
3 years of CRA experience
Site management and CRO/vendor oversight
Proficiency with Microsoft Office and Veeva eTMF required
Phase I–III Experience

Job Responsibility

Support clinical operations across multiple studies while ensuring subject safety and data integrity
Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines
Support study start-up and ongoing trial activities, including regulatory documentation and site readiness
Serve as a liaison between internal teams, CROs, vendors, and investigator sites
Review monitoring visit reports (PSV, SIV, IMV, COV)
Remotely track enrollment and treatment status using IxRS and EDC systems
Maintain study tracking tools, meeting minutes, and action items
Participate in investigator meetings, study training, and co-monitoring activities as needed
Perform duties in compliance with FDA regulations, ICH-GCP, and company policies

What we offer

Medical
dental
vision
401(k)
telehealth services
ESOP
commuter benefits

Fulltime

Site Care Partner

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

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Good communication, presentation, and interpersonal skills
Ability to manage required travel
Demonstrated networking and relationship building skills
Demonstrated ability to manage cross functional relationships
Ability to communicate effectively and appropriately with internal & external stakeholders
Ability to adapt to changing technologies and processes
Knowledge of country requirements for GCP that may be different to those of client procedures
Effectively overcoming barriers encountered during the implementation of new processes and systems

Job Responsibility

Site start-up and activation
Deploys client site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selection
Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision
Maintains a knowledge of assigned protocols
Conducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation
Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
Supports country specific ICF review and deployment up to Site Activation
Ensures follow up activities’ completion post Site qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV)
Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV

What we offer

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

Fulltime

Senior Clinical Site Manager

Senior Clinical Site Manager (SCRA) – Home-Based | Adelaide or Melbourne | Rare ...

Location

Australia , Melbourne

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience as a CRA II or Senior CRA within a CRO, biotech, or pharmaceutical environment
Strong site-facing experience with proven ability to build and maintain relationships
Excellent problem-solving skills and ability to think creatively to overcome recruitment challenges
High attention to detail with experience reviewing data and identifying site issues
Outstanding communication skills with the ability to adapt style across different audiences
Solid knowledge of ICH-GCP and clinical trial processes
Ability to work independently in a fast-paced, global environment

Job Responsibility

Build, develop, and maintain strong relationships with investigators and site staff
Lead all aspects of site management, including selection, initiation, monitoring, and close-out visits
Identify site performance trends and proactively address recruitment or operational challenges
Review data and site metrics to identify risks and implement solutions
Act as the primary point of contact for study sites
Support study delivery through collaboration with Project Managers, vendors, and internal teams
Contribute to study start-up activities, documentation, and regulatory submissions
Ensure studies remain audit and inspection ready at all times
Drive innovative approaches to improve site engagement and patient recruitment

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

Parttime

Senior Project Manager

As a Senior Project Manager, Laboratory at ICON, you will design and analyse cli...

Location

United States , Blue Bell

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 project management within a laboratory or clinical research setting
Strong leadership skills with the ability to mentor and train junior PMs
Excellent communication and interpersonal skills, with the ability to represent the company at client meetings and internal meetings
Detail-oriented with strong organizational skills to effectively manage study documentation, timelines, and budgets
Willingness to travel as required (approximately 20%)
Minimum of 5 years of experience in a clinical laboratory, clinical trials, or customer management role in a life science related organization
Minimum of 3 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical supply packaging and distribution, medical imaging, data management

Job Responsibility

Ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories' (ICL) services, including the setup and day-to-day management of studies
Attend and represent ICL at Client meetings
Manage studies in accordance with Good Clinical Practice
Provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner
Represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON
Act as the sponsor’s main contact person in all matters regarding our central laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON Site Services Department
Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Central Laboratories (and ICON Clinical CRO if appropriate)
Enter protocol parameter information into PACS//ICOLIMS and other systems for new and/or amended protocols. Prepare and review clinical study specific materials. When possible, coordinate with other departments for the preparation of study specific materials
Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained and filed
Monitor study progress throughout the study, using ICON tools and communicate pertinent information to clients/sponsors. Provide Sponsors with study management reports. Provide client with support on ICO Labs system. Inform team leader about study progress. Escalate issues of potential client/site dissatisfaction to appropriate management

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 CRA - Ph 1/2

A clinical-stage biotechnology organization is seeking an experienced Senior CRA...

Location

United States

Salary:

75.00 - 90.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences or related discipline
4+ years of In House CRA experience within a sponsor or biotech environment
Experience supporting global clinical trials
Phase I/II trial experience required
Demonstrated experience in site oversight and vendor management
Experience contributing to clinical study management activities

Job Responsibility

Support the Global Clinical Study Lead/Senior Clinical Trial Manager in the operational management of Phase I/II trials from study start-up through close
Provide oversight of CRO monitoring activities, ensuring quality and adherence to protocol and GCP
Act as a key point of escalation for site-related operational issues
Contribute to protocol development, study design discussions, and operational feasibility
Manage operational aspects of investigative site relationships and study execution
Oversee external vendors (IRT, eCOA, cardiac safety, patient reimbursement, etc.) and support vendor performance management
Participate in vendor selection activities, including RFP review and bid defenses
Support development and maintenance of study timelines, operational plans, and budgets
Contribute to development of key study documents and site-facing materials
Support CRF design, UAT, edit check review, and data quality oversight

What we offer

medical
dental
401(k)
direct deposit
commuter benefits

Senior CRA - Ph 2/3

A growing biotechnology organization is seeking an experienced Senior CRA to sup...

Location

United States

Salary:

75.00 - 90.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences or related discipline
4+ years of in-house CRA experience within a sponsor or biotech environment
Experience supporting global clinical trials
Phase II/III trial experience required
Demonstrated experience in site oversight and vendor management
Experience contributing to clinical study management activities

Job Responsibility

Support the Global Clinical Study Lead / Senior Clinical Trial Manager in the operational management of Phase II/III trials from study start-up through closeout
Provide oversight of CRO monitoring activities, ensuring quality, protocol compliance, and GCP adherence
Act as a key point of escalation for site-related operational issues
Contribute to protocol development, study design discussions, and operational feasibility
Manage operational aspects of investigative site relationships and study execution
Oversee external vendors (IRT, eCOA, cardiac safety, patient reimbursement, etc.) and support vendor performance management
Participate in vendor selection activities, including RFP review and bid defenses
Support development and maintenance of study timelines, operational plans, and budgets
Contribute to the development of key study documents and site-facing materials
Support CRF design, UAT, edit check review, and data quality oversight

What we offer

medical
dental
401(k)
direct deposit
commuter benefits

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Study Start Up CRA

Job Description

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