In-Demand Research coordinator Jobs in Parramatta Nsw

Sr Clinical Research Associate II - Sydney
Fortrea —Sydney NSW
- Full-time
- Management
- Patient monitoring
- Bachelor's degree
10d
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LEWIS —Sydney NSW
- Presentation skills
- AI
Strategy & Business Operations Associate
SKUTOPIA —Alexandria NSW
- Full-time
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- AI
- Business
- Gym membership
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Product Manager, Intelligence
Heidi —Sydney NSW
- Full-time
- Hybrid work
- Bachelor's degree
- APIs
- AI
- Work from home
- Parental leave
Producer
Radical Orange —Surry Hills NSW
- Full-time
- Editing
Aboriginal Chronic Care Coordinator Clinical Nurse Consultant
NSW Health —Frenchs Forest NSW
- $2,780.00 - $2,835.50 a week
- Full-time
- Leadership
10h
Clinical Project Manager (Oncology)
Tardis Group —Sydney NSW
- Management
- Research
- Presentation skills
Business Director
MOI Global —Sydney NSW
- Full-time
- Hybrid work
- Management
- Sales
- Marketing
- Annual leave
Quick Apply
Strategic Account manager
Lupo Digital —Sydney NSW
- Full-time
- Google Suite
- Management
- SQL
- Work from home
Head of Product Design
Heidi —Sydney NSW
- Full-time
- Remote
- AI
- Work from home
- Parental leave
Occupational Therapist - North West Sydney
Concentric —Winston Hills NSW
- Full-time
- Education
- Employee assistance program
Digital Marketing Coordinator and Support Role
Lupo Digital —Sydney NSW
- CRM software
- Management
- Sales
- Annual leave
Product Manager, Apps
Heidi —Sydney NSW
- Full-time
- Hybrid work
- Bachelor's degree
- AI
- Work from home
- Parental leave
Digital Marketing Specialist
Red Star Hotel Group —West Ryde NSW
- Management
- Marketing
- Writing skills
Mid Market Account Executive
Contentful —Sydney NSW
- Full-time
- Sales
- Bachelor's degree
- APIs
- Annual leave
- Employee assistance program
Cleaning Team Member
St Vincent's Health Australia —Darlinghurst NSW
- $36.39 an hour
- Weekend availability
- University
- Cleaning
- Communication skills
- Employee discount
5d
Clinical Nurse Specialist
St Vincent's Health Australia —Inner West NSW
- $62.21 an hour
- Full-time
- Discharge planning
- Nursing
Physiotherapist-Homecare Northern Sydney
Concentric —Ryde NSW
- Full-time
- Education
- Employee assistance program

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Sr Clinical Research Associate II - Sydney

Fortrea -
Sydney NSW

Apply Now

Job Details

Full-time
10 days ago

Qualifications

Management
Patient monitoring
Ophthalmology
Bachelor's degree

Full Job Description

Job Overview:

The Senior Clinical Research Associate II (Sr CRA II) is responsible and accountable for site monitoring and site management for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited scope, as assigned and assumes line management responsibilities, as assigned. Acts in the project role of a Local Project Coordinator or Lead CRA as assigned.

Summary of Responsibilities:

The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible data.
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
Ensure audit readiness at the site level.
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports.
Manage small projects under the direction of a Project Manager/Director as assigned.
Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
Review progress of projects and initiate appropriate actions to achieve target objectives.
Organize and make presentations at Investigator Meetings.
Participate in the development of protocols and Case Report Forms as assigned.
Participate in writing clinical trial reports as assigned.
Interact with internal work groups to evaluate needs, resources and timelines.
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Responsible for all aspects of registry management as prescribed in the project plans.
Undertake feasibility work when requested.
Conduct, report, and follow-up on Quality Control (QC) visits when requested.
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
Assist with training, mentoring and development of new employees, e.g., co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
Perform other duties as needed or assigned.

Qualifications (Minimum Required):

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), an equivalent amount of experience can be substituted as appropriate.
Thorough knowledge of regulatory requirements.
Thorough understanding of the drug development process.
Fortrea may consider relevant and equivalent experience in lieu of educational requirement.

Experience (Minimum Required):

Advanced Clinical Monitoring experience
A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience
Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Advanced study site management skills.
Ability to work with minimal supervision.
Good planning and organization skills.
Works efficiently and effectively in a matrix environment.

Travel Requirement:

Willingness to travel up to 40% with overnight stay away from home.

Learn more about our EEO & Accommodations request here .

Apply Now

Refine Your Search

research coordinator jobs in parramatta nsw

Sr Clinical Research Associate II - Sydney

Freelance (Talent Bank)

Strategy & Business Operations Associate

Product Manager, Intelligence

Producer

Aboriginal Chronic Care Coordinator Clinical Nurse Consultant

Clinical Project Manager (Oncology)

Business Director

Strategic Account manager

Head of Product Design

Occupational Therapist - North West Sydney

Digital Marketing Coordinator and Support Role

Product Manager, Apps

Digital Marketing Specialist

Mid Market Account Executive

Cleaning Team Member

Clinical Nurse Specialist

Physiotherapist-Homecare Northern Sydney

I want to receive the latest job alert for research coordinator in parramatta nsw

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