Clinical Research Associate Entry Level Job at iconplc (Sao Paulo)

Clinical Site Associate / Clinical Trial Associate

Clinical Site Associate / Clinical Trial Associate, Office-based (hybrid) in Syd...

Location

Australia , Sydney

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, healthcare, business, or a related field, or equivalent experience
Initial experience in clinical research, administration, or a similar regulated environment is preferred
Strong organisational skills with the ability to manage multiple tasks, priorities, and deadlines
High attention to detail and accuracy in documentation and data entry
Effective written and verbal communication skills, with a customer-focused approach to site support
Proficiency with MS Office and comfort working with electronic systems and databases
Ability to work collaboratively in a team environment and adapt to changing priorities

Job Responsibility

Supporting site activation activities, including the collection, review, and tracking of essential documents and approvals
Maintaining up-to-date site information and status in clinical trial management systems and trackers
Assisting CRAs and project teams with site communications, follow-up, and resolution of site-level queries
Coordinating logistics for site visits and meetings, including scheduling, documentation preparation, and follow-up actions
Ensuring accurate filing and maintenance of essential documents to support inspection and audit readiness
Collaborating with internal stakeholders to support timely site payment processing and issue resolution
Contributing to process improvement initiatives and sharing best practices to enhance site support efficiency

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

Clinical Research Associate II

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

Location

Taiwan , Taipei

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Sound problem solving skills
Able to take initiative and work independently
Advance presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
Willingness to work in a matrix environment

Job Responsibility

Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up
Address and resolve issues at sites
Follow-up on and respond to appropriate site related questions
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections
Collect, review, and approve updated/amended site documentation
Evaluate site recruitment plan in collaboration with the site staff

Clinical Research Associate II - XTA

Clinical Research Associate - Cross Therapeutic Area - Chicago. ICON plc is a wo...

Location

United States , Chicago

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
Experienced monitoring across multiple therapeutic areas
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

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
Global Employee Assistance Programme, LifeWorks with 24-hour access
Life assurance
Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Initiation Clinical Research Associate

Location

Brazil

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Communicator
Detail-oriented
Flexible
Organized
Problem-solver
Self-starter
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments
May conduct remote Qualification Visits (QVs)
Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (Site SIV Readiness/Greenlight Documents) and any updated or amended regulatory documentation
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy

What we offer

Flexible work arrangements

Senior Clinical Research Associate

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

Location

France , Paris Region

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in oncology trials and RECIST criteria is 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
Advanced level or fluency in English is required

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensuring regulatory, ICH-GCP and protocol compliance
Verifies the process of obtaining informed consent
Demonstrates diligence in protecting the confidentiality of each subject
Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods
Conducts source document review and verification
Manages reporting of protocol deviations and appropriate follow up
Applies query resolution techniques remotely and on site
May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
Verifies the IP has been dispensed and administered to subjects

Fulltime

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 II - Multi-Sponsor

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

Location

Italy , Milan

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Close to at least 2 years independent monitoring experience in a similar setting
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Sound problem solving skills
Able to take initiative and work independently
Advance presentation skills
Client focused approach to work
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
Willingness to work in a matrix environment

Job Responsibility

Act as PAREXEL's direct contact with assigned sites
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems
Evaluate if on-site staff assignment is still accurate
Address and resolve issues at sites
Follow-up on and respond to appropriate site related questions
Apply working knowledge to identify and evaluate potential data quality and data integrity issues
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required
Collect, review, and approve updated/amended site documentation
Evaluate site recruitment plan

Fulltime