facebook

Job details

Location
Gordon, Ku-ring-gai Council, New South Wales
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35958_1623718386
Contact
Jillian Swoyer
Posted
about 1 month ago

Job details

Location
Gordon, Ku-ring-gai Council, New South Wales
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35958_1623718386
Contact
Jillian Swoyer
Posted
about 1 month ago

Benefits

  • Opportunity to be contracted within a Global Pharmaceutical Company with large pipeline of oncology studies
  • Fast paced environment with scope to take full ownership of studies from start up to close out
  • Home-based with option to work in the office as needed
  • Competitive salary with opportunities to grow within the business

About The Company

This opportunity will be within a Global CRO reporting directly to a single sponsor. This market leading pharmaceutical company is expanding their team to take on a variety of new studies and indications into the coming year with a specific focus on oncology. Experienced Clinical Research Associate II (CRA II) are needed on a permanent, full time basis.


About the opportunity

The CRA II is responsible for the site initiation, interim monitoring and closure of an agreed number of centres in clinical studies according to Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.

Responsibilities

  • Verifies the process of obtaining informed consent has been adequately performed and documented for each participant and demonstrates confidentiality of each patient/ participant
  • Assess factors that may affect safety of participants and clinical data integrity
  • Assess site processes, conduct source document reviews or appropriate site source documents and medical records
  • Verify required clinical data entered into the case report forms are accurate and correct
  • Initiate, monitor and close study sites in compliance with Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.
  • Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
  • Update database and other systems with data from centres as per required timelines.
  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
  • Perform source data verification according to SDV plan.
  • Ensure data query resolution.
  • Ensure accurate and timely reporting of Serious Adverse Events.

Skills and Experience

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
  • Strong computer skills and ability to embrace new technology
  • Ability to travel up to 75% on a regular basis (when boarder closures allow)

Click apply or contact Jill Manson at jmanson@hpgconnect.com



Similar jobs

about 1 month ago

Clinical Research

Clinical Research Associate/Senior Cl...

  • Melbourne
  • Negotiable

About the Company Our client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company covers all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

about 1 month ago

Clinical Research

Clinical Research Associate/Senior Cl...

  • Perth
  • Up to AU$0.00 per annum

About the Company Our client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company covers all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

about 1 month ago

Clinical Research

Senior Clinical Research Associate

  • Melbourne
  • Negotiable

About the CompanyOur client is a pioneering medical device company that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnoea for patients that have failed or refused continuous positive airway pressure (CPAP) therapy.About the opportunityThis company are currently seeking a Senior Clinical Researc...

about 1 month ago

Clinical Research

Clinical Research Associate I

  • Melbourne
  • Up to AU$0.00 per annum

About the CompanyOur client is a pioneering medical device company that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnoea for patients that have failed or refused continuous positive airway pressure (CPAP) therapy.About the opportunityThis company are currently seeking a Clinical Research Assoc...

6 days ago

Clinical Research

Clinical Research Associate/Senior Cl...

  • Australia
  • Up to AU$0.00 per annum

About the company This global healthcare organisation has built its reputation on having a holistic approach which allows them to generate exceptional standpoints that they use to create solutions for their customers.About the opportunity This is an opportunity to step into a role within a...

5 days ago

Clinical Research

Clinical Research Associate

  • Brisbane, Queensland
  • Negotiable

BenefitsExcellent training and development opportunitiesAttractive salary package plus car allowanceFlexible Working arrangements - Home / Office basedSingle Sponsor About the companyWorking for a Global full service CRO on global delivery, scientific leadership, and various therapeutic sp...

5 days ago

Clinical Research

Clinical Research Associate

  • New Zealand
  • Negotiable

BenefitsExcellent training and development opportunitiesAttractive salary package plus car allowanceFlexible Working arrangements - Home / Office basedSingle Sponsor About the companyWorking for a Global full service CRO on global delivery, scientific leadership, and various therapeutic sp...

5 days ago

Clinical Research

Clinical Research Associate

  • St Leonards, New South Wales
  • Negotiable

BenefitsExcellent training and development opportunitiesAttractive salary package plus car allowanceFlexible Working arrangements - Home / Office basedSingle SponsorAbout the companyWorking for a Global full service CRO on global delivery, scientific leadership, and various therapeutic spe...

9 days ago

Clinical Research

Senior Clinical Research Associate

  • Macquarie Park
  • Negotiable

Benefits Opportunity for growth and development within leading sponsor.Work in an innovative and adaptable environment.Supportive team with good leadership and flexibility to work from home.Guaranteed completion bonus 10%About The Company Market leading pharmaceutical company is ex...

6 days ago

Clinical Research

Clinical Project Director

  • Australia
  • Up to AU$0.00 per annum

About the company A growing, global Clinical Research Organisation with global presenceInternationally recognised for its high standard in designing and implementing clinical research in a large range of therapeutic areasAbout the opportunity Overall management and quality of a group of projects for a part...

6 days ago

Clinical Research

Clinical Project Manager

  • Australia
  • Up to AU$0.00 per annum

The award of new projects has resulted in numerous opportunities arising for skilled Clinical Project Managers for a global medium CRO. They are open to all experienced Clinical Project Manager applicants across Australia. Within this company you will be working on thrilling new projects with regional and/or global teams, in a CRO that genuinely...

about 1 month ago

Clinical Research

Clinical Field Engineer/Sleep Scientist

  • Melbourne
  • Negotiable

About the CompanyOur client is a medical device company that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnoea for patients that have failed or refused continuous positive airway pressure (CPAP) therapy.About the opportunityThis company are currently seeking an experienced Sleep Scienti...