Contract Senior Clinical Research Associate Job at iconplc (Los Angeles)

Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - East Coast. ICON plc is a world-...

Location

United States , Atlanta; Texas; Maryland; Missouri; Tennessee; North Carolina; Illinois; Ohio; Florida; Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution
a licensed health care professional (i.e. registered nurse) or equivalent work experience required
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English
Oncology monitoring experience required
Experience doing feasibility/site selection/site start up required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
Completes monitoring activity documents as required by sponsor's SOPs
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed
Performs essential document site file reconciliation
Performs source document verification and query resolution

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 Associate Clinical Pricing & Payments

Investigator Pricing Analyst Home based Spain, UK and other countries! ICON plc ...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

3-5 years’ work experience in financial support or contract administration role
BA/BS/BSc in Finance or Accounting

Job Responsibility

Support Global Development Operations, Global Study and Clinical Management Groups and Therapeutic Area Teams by creation of pricing proposals for clinical study budgets, consulting and related agreements
Support Finance in the development of study level budget estimates using pricing tools
Development of fair market value negotiation guidelines for each pricing request
Maintain database of information related to pricing
Ownership of pricing tools and templates/forms
Participating in team/department special projects as required
Receive pricing requests from Clinical Development Study Clients for original or amended budgets
Review study protocol or consulting scope of work and discuss with Clinical Study Team
Use industry benchmarking pricing tool(s) and internal historical data to create base clinical study budget or recommendation for consultant or services compensation
Create budget spreadsheet and corresponding documentation to be incorporated into Agreement

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 Associate

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

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills

Job Responsibility

Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list

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 maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

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

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US) ICON plc is a wo...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance 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 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

Study Delivery Senior Associate

The Study Delivery Senior Associate provides essential global study management s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree OR Bachelor’s degree and 2 years of clinical execution experience OR Associate’s degree and 6 years of clinical execution experience OR High school diploma / GED and 8 years of clinical execution experience
3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working on global clinical trials
Strong collaborative and effective communication skills within a team environment
Understands importance of accuracy in documentation, data tracking, and compliance checks
Identifies discrepancies and escalates appropriately
Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Ability to maintain accurate and timely data entry

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
Lead delivery of assigned risk and quality management activities
Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
Manage Study Training system activities and oversight
Build and maintain effective relationships with internal study team members, vendors and investigator sites
Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned

Fulltime

Senior Study Start Up Associate

Senior Study Start Up Associate - São Paulo (FSP - Sponsor Dedicated). ICON plc ...

Location

Brazil , São Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
Solid experience or understanding of clinical study start-up requirements and activities
Fluency in the local language and English is essential

Job Responsibility

Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities
Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success
Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines
Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent

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

New

Senior Local Operations Manager - Oncology Solid Tumor - Home Based

The Senior LOM role is a site aligned E2E partner to streamline communication ac...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate
Applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
when necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance 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 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

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Contract Senior Clinical Research Associate

Job Description

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