Clinical Study Associate Job at Proclinical (Cambridge)

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

Clinical Research Associate II/Senior Clinical Research Associate

As a CRA at ICON, you will design and analyze clinical trials, interpreting comp...

Location

Poland , Warsaw; Poznan

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 1 year 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
Ability to work independently and collaboratively in a fast-paced environment
Willingness to travel as required

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

Clinical Research Associate II/Sr. Clinical Research Associate - 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

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
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 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
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
Provide protocol training to, and address protocol related questions from the investigator site staff when required
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
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 and follow-up with investigators sites, as needed

What we offer

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

Senior Clinical Research Associate or Clinical Research Associate II

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 scientific or healthcare-related field
Minimum of 1-year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate
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 60% of the time (international and domestic - fly and drive)

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

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

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

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or 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
Ability to work independently and collaboratively in a fast-paced environment
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 skills in German and English
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

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

Senior Clinical Study Associate

Be the backbone of clinical research-join a team shaping tomorrow's therapies. P...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong understanding of clinical trial processes and regulatory requirements
Experience with TMF management and document tracking
Proficiency in managing laboratory vendors and coordinating sample logistics
Ability to review and analyze site performance metrics and monitoring reports
Excellent organizational and communication skills
Familiarity with site contracts, budgets, and feasibility assessments
Ability to work collaboratively with cross-functional teams and external vendors

Job Responsibility

Oversee day-to-day clinical trial execution, including site start-up, patient enrollment, and monitoring
Support the Clinical Study Manager and team members in managing trial activities
Prepare study documents such as consent forms, site instructions, and study-specific materials (e.g., Manual of Operations, Pharmacy Binder)
Track essential documents, ensuring accuracy and proper filing in the Trial Master File (TMF)
Monitor patient status at investigative sites and ensure accurate tracking
Manage sample collection, laboratory testing schedules, and central laboratory reporting
Assist with laboratory vendor management and liaise with CROs and clinical trial sites for sample handling and result reporting
Review monitoring trip reports, track data query reports, and assess site visit metrics and performance
Participate in site initiation, routine monitoring, and close-out visits, including co-monitoring with CROs
Ensure data quality from clinical sites and assist in resolving subject eligibility and protocol deviation issues

Sr. Associate Systems Analyst – Clinical Study Design and Analysis

The Systems Analyst – Clinical Study Design and Analysis will collaborate with n...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree OR Bachelor’s degree with 5- 9 years of experience in Information Systems Administration/Support/Validation
Experience with GxP-regulated computer system validation
Experience with Agile software development methodologies (Scrum)
Experience with validation solutions, tools, and methodologies

Job Responsibility

Support, monitor, or execute the installation of infrastructure security patches and configuration changes, as necessary
Review system release notes and identify regression test requirements
Develop detailed test plans and strategies based on release notes, project requirements, and specifications documents
Perform manual and automated testing of software applications, including functional, regression, and performance testing
Document and report defects and issues identified during testing, and work with development teams to resolve them
Maintain detailed documentation of test/validation plans, test cases, and test results
Advise on the documentation of requirements to ensure that they are written in a testable manner
Validate that test scenarios meet feature acceptance criteria and customer expectations
Maintain and ensure the quality of documented user stories/requirements in tools such as Jira
Prepare, execute, document, and report validation protocols in line with GxP’s and other regulatory requirements and standards

Fulltime

Senior Associate Clinical Supply Chain – Global Clinical Customer Service (GCCS)

Reporting to the Manager, Development Supply Chain, you will support the global ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s Degree & 4+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR Bachelor’s Degree & 5+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR Associate’s Degree & 8+ years of relevant experience
OR High School Diploma / GED & 10+ years of relevant experience
Experience in clinical supply chain, pharmaceutical operations, or regulated operational environments
Strong problem-solving, issue resolution, and analytical skills
Ability to work effectively in a global, matrixed environment
Strong service-oriented mindset, responsiveness, and stakeholder support skills

Job Responsibility

Manage and resolve distribution complaints related to investigational product shipments supporting global clinical trials
Intake and triage Category-1 inquiries from clinical sites, study teams, and internal stakeholders
Coordinate cross-functional issue resolution and escalate risks appropriately
Review temperature data for investigational product shipments delivered to clinical trial sites
Perform temperature excursion assessments within Quality Management Systems following established procedures
Partner with Quality and study teams to support investigations, disposition decisions, and inventory status updates
Maintain accurate, complete, and inspection-ready documentation
Support study-level reconciliation activities to ensure accurate investigational product accountability
Manage investigational product returns in accordance with procedures and regulatory requirements
Support intake, documentation, and coordination of investigational product complaints

Fulltime

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Clinical Study Associate

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