Clinical Trial Operations Associate Job at Beacon Biosignals (Boston)

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

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/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 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

Clinical Trial Associate

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BS/BA degree or degree in healthcare field required
Direct experience supporting clinical operations activities, 1+ years in pharma/biotech company or 2+ years of experience in a CRO
Very strong foundational understanding of clinical trials, and have prior experience in the administrative aspects of clinical operations
Experience managing the TMF with a solid understanding of filing expectations at study, country, and site levels
Experience managing the CTMS, study team lists, SharePoint accesses
Taking diligent meeting agendas/minutes
Tracking and following up on action items with a fundamental understanding what goes into each action
Tracking study plans & training compliance
Maintaining ongoing systemic reviews, such as User Access Reviews, eSystems List Reviews, Global Vendor Listing Reviews
Effective written and verbal communication skills, with the ability to work collaboratively within study teams

Job Responsibility

Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
Set up, organize and maintain study files and shared spaces in accordance with study requirements
Coordinate and track study training
Manage study sample and supply tracking and support interactions with vendors as needed
Support the Study Management team with specific projects
Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues
Perform routine quality checks on trial level documents to ensure completeness and accuracy
Supports the timely, complete and compliant archiving in the TMF

Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

Fulltime

Senior Clinical Trial Associate

Our client is looking to fill the role of CTA. The Senior Clinical Trial Associa...

Location

United States , San Diego

Salary:

35.00 - 48.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences or a related field preferred
Minimum of 3 years of clinical operations or clinical trial support experience
Experience supporting clinical studies within the biotechnology, pharmaceutical, medical device, or CRO industry preferred
Autoimmune experience required
Working knowledge of clinical trial processes, documentation, and GCP requirements
Strong organizational skills with exceptional attention to detail
Proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint
Strong written and verbal communication skills
Ability to manage multiple priorities and work effectively in a collaborative environment

Job Responsibility

Support day-to-day clinical trial operations across one or more studies
Maintain and organize Trial Master File (TMF) documentation and track essential study records
Monitor document status and communicate outstanding items to the study team
Track study metrics, enrollment, site activity, and clinical supply information
Assist with vendor, CRO, and site coordination activities
Support invoice tracking, reconciliation, and study budget administration
Identify and communicate study issues, risks, or operational concerns to the clinical team
Assist with review and management of study-related documents and materials
Ensure compliance with applicable regulations, GCP guidelines, SOPs, and study requirements
Perform additional clinical operations activities as assigned

What we offer

Medical
dental
401(k)
direct deposit
commuter benefits

Fulltime

Global Clinical Trial Associate

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

Location

China , Shanghai

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field
Previous experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry
Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively
Excellent attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance
Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships with study teams and clinical sites

Job Responsibility

Assist in the planning, execution, and monitoring of clinical trials, ensuring adherence to protocol requirements, regulatory guidelines, and industry standards
Coordinate study activities including site initiation, patient recruitment, data collection, and monitoring visits to ensure timely and accurate data collection and documentation
Collaborate with cross-functional teams including Clinical Operations, Data Management, and Biometrics to support the successful execution of clinical trials
Maintain comprehensive study documentation and records, ensuring compliance with applicable regulations and standard operating procedures
Support study close-out activities including data cleaning, analysis, and preparation of 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

Select Country

Clinical Trial Operations Associate

Job Description

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Requirements

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