Ethics Submission Coordinator Job at Austin Health (Melbourne)

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Study Start Up Associate II

We are currently seeking a Study Start Up Associate II to join our diverse and d...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Initial and Amendment for IRB Submission

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

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

Study Start Up Associate I

Regulatory Exp.- Home Based - CDMX. ICON plc is a world-leading healthcare intel...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

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

Study Start Up Associate

Study Start-Up Associate - home-based - South Korea- ICON Strategic Solutions. I...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

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 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

Labor Compliance Analyst

The Labor Compliance Analyst is responsible for ensuring strict adherence to fed...

Location

United States , Capitol Heights

Salary:

65000.00 - 78000.00 USD / Year

Clark Construction Company

Expiration Date

Until further notice

Requirements

Bachelor's degree preferred, or no degree with 5+ years of relevant experience
Experience with LCP Tracker or similar software
Familiarity with OFCCP, DOL WHD, Small Business tracking, and other related FAR clauses
Experience with Certified Payroll review and management
Highly motivated individual with strong organizational and time management skills
Excellent oral and written communication skills
Careful attention to detail and reliability of output
Ability to work under pressure in a fast-paced team environment
Alignment to Clark Standards of Excellence: self-motivated, results-oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction, and executes

Job Responsibility

Review and Approval of Certified Payroll: Conduct thorough audits and approval of weekly Certified Payroll Reports (CPRs) and supporting documentation submitted by prime and subcontractors via compliance software
Davis-Bacon and Prevailing Wage Expertise: Analyze projects and contracts to determine the correct applicability of the Davis-Bacon Act (DBA) and other prevailing wage laws
Non-Compliance and Resolution: Identify discrepancies, underpayments, and non-compliance issues in payroll submissions
Payment Coordination: Recommend and coordinate payment holds or withholdings to secure restitution for wage violations
Union Rule Interpretation: Interpret and apply complex rules and regulations contained within Project Labor Agreements (PLAs) and Collective Bargaining Agreements (CBAs)
Craft Labor Matching and Verification: Conduct on-site field audits, worker interviews, and observations to verify job duties align with labor classification
Apprenticeship Monitoring: Review and verify documentation for apprentices
Classification Conformance: Manage the process for requesting and obtaining additional craft classifications and wage rates
Labor Investigations: Investigate alleged wage complaints and labor law violations
Contractor Training: Deliver training to contractors, subcontractors, and project management teams on prevailing wage requirements

What we offer

health/dental/vision benefits
paid time off
retirement/401k
Company Contribution plan
life insurance
commuter benefit
short & long term disability
fitness reimbursement
FSA
tuition reimbursement

Fulltime

New

Executive Assistant

Are you an exceptional Executive Assistant who thrives in a fast-paced, executiv...

Location

Australia , Brisbane

Salary:

Not provided

Aurizon

Expiration Date

March 20, 2026

Requirements

Minimum 5 years’ experience in senior administrative support roles
Proven experience supporting multiple senior leaders or executives
Demonstrated experience coordinating Board or Committee papers, governance documentation or executive submissions (highly regarded)
Exceptional planning, coordination and time management skills
Strong written and verbal communication skills with the ability to influence and negotiate
High proficiency across Microsoft Office, Microsoft 365, Co-pilot (or similar) and SAP (or similar systems), digital workflow tools and enterprise communication tools
Ability to work autonomously while collaborating effectively across teams
A proactive, professional approach with strong ethical and discretion
Exposure to People, Safety, Learning, Technology or enterprise corporate environments (desirable)

Job Responsibility

Provide high-level executive support to the Group Executive
Coordinate complex diaries, meetings, travel, conferences and stakeholder engagements across a large, multi-disciplinary portfolio
Prepare high-quality reports, presentations, papers and correspondence for executive, Board and Committee forums
Coordinate the Board and Committee papers end-to-end, ensuring accuracy, governance compliance and timely submission
Support executive and leadership meetings through agenda preparation, minute taking and action tracking
Proactively flag priority matters and emerging risk, ensuring timely submission
Build strong, trusted relationships with executives, senior leaders, and internal/external stakeholders
Streamline administrative systems and processes for efficiency and effectiveness
Maintain records and documentation in line with governance, confidentiality and compliance standards
Support ad hoc projects and initiatives as required across the portfolio

What we offer

Attractive salary
benefits and development opportunities
Development and growth opportunities
Access to mentoring and development programs
Discounts on selected health insurance funds, personal travel, gyms, vehicles and retail brands
Parental leave program and super booster

Fulltime

New

Local Delivery Lead

Provides leadership, oversight and manages the activities of within-country oper...

Location

Canada , Mississauga

Salary:

121000.00 - 171000.00 CAD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 3 years of clinical research experience within GSK or externally.
Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives.
Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
Effective at problem solving, negotiation and conflict resolution skills in a matrix environment
Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
Strong written and verbal communications skills are required in English and local language of the countr(ies).
Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. Recognizes potential risks and can implement effective mitigation strategies.
Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.

Job Responsibility

Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery
providing both matrix leadership and project mangement of study activities within the countr(ies).
Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).
Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPs and POLs.
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.
Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
Identifies and resolves or escalate risks and issues that may impact study delivery.
Provides feedback on performance, capabilities and competencies of study members to line management. As required, will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Ethics Submission Coordinator

Austin Health

Location:
Australia , Melbourne

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 20, 2026

Expiration:
March 31, 2026

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