Senior or Lead Clinical Research Associate Job at iconplc (Taipei)

Senior Clinical Research Associate

Location

Canada , Montreal, Ontario, Toronto

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
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
Willingness to travel as required (approximately 60%)
Bilingual in French and English

Job Responsibility

Lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
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

Fulltime

Senior Clinical Research Associate

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

Location

France , Paris

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
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
Willingness to travel as required (approximately 60%)

Job Responsibility

Lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
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

Fulltime

Senior Clinical Research Associate

Senior Clinical Research Associate, FSP Model, Paris, Hybrid or Home based, Prod...

Location

France , Paris

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 (4/5 years independent monitoring or more), with a proven track record of managing complex trials within a CRO or Pharma environment
Fluency in French and professional proficiency in English (mandatory for reporting and international stakeholder management)
In-depth knowledge of ICH-GCP guidelines
Proven ability to manage multiple high-priority sites and projects simultaneously, with superior organizational and problem-solving skills
Excellent communication and interpersonal skills, with the ability to influence site compliance and represent a leading global sponsor effectively
Ability to travel as required to clinical sites and should possess a valid driver's license

Job Responsibility

Independently monitor Phase II–IV clinical trials as a senior resource dedicated to a major French pharmaceutical leader, ensuring full compliance with ICH-GCP and specific sponsor SOPs
Manage clinical studies in France across multiple complex therapeutic areas including Neurology, Rare Disease, Dermatology and Oncology
Lead site qualification, initiation, monitoring, and close-out visits, providing expert oversight and ensuring the highest standards of site performance
Ensure protocol compliance, data integrity, and participant safety through rigorous source data verification and proactive site management
Build and maintain influential relationships with investigators and site personnel to drive recruitment and facilitate smooth trial operations within this exclusive partnership
Perform advanced data review and resolution of complex queries to maintain the highest quality of clinical data within the sponsor’s proprietary systems
Contribute to the preparation, review, and optimization of study documentation, including monitoring plans and clinical study reports
Oversee study documentation, regulatory submissions, and ethics/IRB approvals to ensure strict adherence to trial timelines
Drive study cost efficiency and provide proactive resolution for site-level issues to meet critical milestones for our pharmaceutical partner

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 Clinical Research Associate

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

Location

Argentina

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
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client 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
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP 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, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
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, to bring SAE reports required information to resolution

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

Senior Clinical Research Associate II - FSP

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

Location

Turkey

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 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client 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
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP 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, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
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, to bring SAE reports required information to resolution

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 Specialist

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 3 years of relevant experience required
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards
Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines, standards preferred
Proficiency in managing multiple and competing priorities/demands
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation
Exceptional interpersonal, organizational, and time management skills
highly collaborative, promotes teamwork
Ability to build collaboration among research team members, laboratory staff, patients, and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)
Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet

Job Responsibility

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols
Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines
Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures
Works closely with study team members and other study sites to ensure the safety and adherence of study participants to the study protocol
Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel
Coordinates enrollment of participants
Oversees and facilitates eligibility screening and study recruitment activities
Plans study timelines and schedules appointments and study visits
Manages and organizes case report forms, source documents, and research records
Enters research data into data collection forms and/or study databases

Fulltime

Senior Research Associate PDP & Manufacturing

The Senior Research Associate PDP & Mfg. plays a critical role as a cGMP scienti...

Location

United States , Sioux Falls

Salary:

Not provided

SAB Biotherapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 3 years of relevant experience or a combination of experience and Master’s or Doctorate degree in a relevant field
Certification in Quality by Design is a plus
Demonstrated proficiency in Microsoft Office applications Word, Excel, PowerPoint, Outlook
Familiarity with chromatography software, preferably Cytiva UNICORN
Basic computer programming knowledge to support use of UNICORN software
Mathematical skills to consist of addition, subtraction, multiplication, division and ability to perform basic statistical analysis, including mean, median, range, mode, standard deviation calculations and related analysis
Ability to calculate dilutions and molarity
Strong time management and organizational skills
Demonstrated ability to effectively work independently with minimal supervision
Excellent verbal and written communications skills and a collaborative approach work

Job Responsibility

Assist in writing and updating related SOPs, records, protocols, reports
Maintain accurate records of activities
Perform bench-scale protein purification
Lead purification needs for reagent production
Work towards optimizing purification methods and protocols for increased yield and purity
Create purification methods in chromatography software programs
Perform statistical analysis as needed
Collaborate with the Supervisor to execute projects to meet timelines
Support the training of associates in purification activities
Purify and Filling product as needed based on Clinical needs

Fulltime

Senior Analyst - Financial - Clinical Research

The Senior Financial Analyst will serve as a subject matter expert in coverage a...

Location

United States , Hollywood

Salary:

Not provided

Memorial Healthcare System

Expiration Date

Until further notice

Requirements

Bachelors (Required)
Three (3) years experience with coverage analysis, clinical trial budget development and negotiation, clinical research study coordination or management, health system operations, or other related research or healthcare experience
A Bachelor s degree in finance, science, business, healthcare administration or related field experience
Critical thinking skills
Effective communication
Decisive judgment
Ability to build and foster positive relationships
Ability to work with minimal supervision

Job Responsibility

Performs comprehensive and independent analysis of clinical trial protocols and other study documents, including the research study budget, contract, informed consent, pharmacy and lab manuals, and other supporting documentation
Perform detailed coverage analysis of research procedures in alignment with CMS rules and develop audit-ready study billing grids
Assist Research Specialists in determining study status under Medicare coverage rules and in identifying services as non-covered research-only, routine care, investigational items, and services along with their associated costs
Lead the development, implementation, analysis and validation of clinical trial financial systems design and operational workflows to optimize performance and productivity
Ensure electronic and paper study files are created, updated, stored, and maintained according to established office practices, and MHS record retention policies, from initial contact to study closeout and beyond
Review and scrub patient bills to ensure claims are being processed accordingly and routed to the correct payor
Analyze industry sponsor budget proposal, clinical trial protocol and manuals to develop and negotiate comprehensive study budgets and payment terms

Fulltime

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Senior or Lead Clinical Research Associate

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