Clinical Project Associate Job at canfield scientific

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

Clinical Trial Operations Associate

Beacon Biosignals is on a mission to revolutionize precision medicine for the br...

Location

United States , Boston

Salary:

Not provided

Beacon Biosignals

Expiration Date

Until further notice

Requirements

Experience in clinical project management or clinical operations roles
Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
Excellent written and verbal communication skills in English
A proactive mindset with the ability to identify priorities and anticipate challenges
Meticulous attention to detail, ensuring accuracy in data collection and reporting
Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
A desire to learn more about analytics, statistics, machine learning, and clinical trials

Job Responsibility

Collaborate with project teams to support study startup activities
Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
Provide actionable feedback from research sites to inform improvements in devices and workflows

What we offer

equity
PTO

Senior Clinical Research Associate

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

Location

Taiwan , Taipei

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
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
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

Clinical Research Associate

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

Location

South Korea , Seoul; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

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
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
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise
Strong ability to make appropriate decisions in ambiguous situations
Willingness to work in a matrix environment and to value the importance of teamwork

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
Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities
Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution
Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, 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
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval, Site activation, Patient recruitment & retention
Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner

What we offer

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

Freelance Clinical Research Associate

As a Clinical Research Associate, you will support the initiation, on-site and r...

Location

Germany , Hamburg

Salary:

Not provided

TFS HealthScience

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, nursing, or equivalent
1+ year of relevant clinical experience
Solid understanding of medical terminology, GCP, ICH guidelines, and regulatory requirements
Strong communication, organization, and time-management skills
tech-savvy and detail-oriented
Ability to work independently and collaboratively in a matrix team environment
Fluent in English
flexible, proactive, analytical, and collaborative mindset

Job Responsibility

Monitor clinical trials on-site and remotely in line with TFS/sponsor SOPs, ICH-GCP, and regulations
Ensure subject safety, protocol adherence, informed consent compliance, and data accuracy
Review source documentation and CRFs and verify Investigational Product management
Document monitoring activities in timely, accurate reports and escalate issues when needed
Maintain ISF and deliver required documents to TMF/eTMF
update CTMS and project systems
Support audits, inspections, and clinical supply management (as applicable)

What we offer

competitive compensation package
comprehensive benefits
opportunity for personal and professional growth in a rewarding environment

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

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Ability to work in an environment of remote collaborators
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials
Good analytical and problem-solving skills
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines

Job Responsibility

Contributes to the selection of potential investigators
Accountable for study start-up and regulatory maintenance (in some countries)
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Proactively identifies and ensures timely resolution to study-related issues
Updates CTMS and other systems with data from study sites

What we offer

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

Freelance Senior Clinical Research Associate

TFS HealthScience is a leading global, mid-size Contract Research Organization (...

Location

Salary:

Not provided

TFS HealthScience

Expiration Date

Until further notice

Requirements

Bachelor’s degree, preferably in life sciences or nursing, or equivalent
Minimum of 2 years of experience working as a CRA (in oncology)
Ability to work in a fast-paced environment with changing priorities
Understanding of basic medical terminology and science related to assigned drugs and therapeutic areas
Solid understanding of Good Clinical Practice (GCP) regulations and ICH guidelines
Ability to work independently and within a team/matrix organization
Excellent written and verbal communication skills
Strong organizational skills
Ability and willingness to travel

Job Responsibility

Monitor clinical trials on-site and remotely in accordance with TFS/client SOPs, FDA regulations, and GCP/ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy
generate queries to resolve data issues
Identify site problems or deficiencies and report them to management through trip reports, memos, and communication with the Project Manager or Lead CRA
Initiate corrective actions as directed by the supervisor
Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager
Participate in contract handling and negotiation under direction of the Lead CRA/Project Manager
Set up the Investigator Site File (ISF) and Study Master File (SMF), or support the CTA in doing so, and distribute materials to investigational sites
Collaborate with the study team on SMF maintenance
Order, ship, and reconcile clinical investigational supplies for study sites, if applicable

What we offer

competitive compensation package
comprehensive benefits
opportunity for personal and professional growth in a rewarding environment

Parttime

Associate Director, Clinical Data Management

The Associate Director, Clinical Data Management plays a key role within the Cli...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors
Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes
Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management
Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting
Proven success in managing vendor relationships and functional service provider (FSP) partnerships
Strong track record of building effective relationships and managing expectations with external partners and vendors
Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation
Bachelor’s degree or higher in Life Science or related discipline

Job Responsibility

Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress
Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors
Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)
Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards
Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment
Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency
Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences
Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)
Monitor vendor performance and quality
escalate issues to management and implement corrective actions as appropriate

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Clinical Project Associate

canfield scientific

Location:

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 07, 2025

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