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Job details

Location
Macquarie Park
Salary
Great salary package
Job Type
Full Time
Ref
BH-39248
Contact
Davina Ocansey
Contact email
Email Davina
Contact phone
+61 2 8877 8712
Posted
16 days ago

Job details

Location
Macquarie Park
Salary
Great salary package
Job Type
Full Time
Ref
BH-39248
Contact
Davina Ocansey
Contact email
Email Davina
Contact phone
+61 2 8877 8712
Posted
16 days ago
Benefits
 
  • Opportunities for growth within the company
  • Work in the exciting space of Rare Diseases
 

About the company
 
Our client is a leading pharmaceutical company, pushing through even the most challenging rare, and devastating diseases. Their goal is to create medical breakthroughs for patients who have heard too many times that they do not have treatment options. Known for specializing in a range of rare diseases across neurology, hematology, nephrology, ophthalmology, and cardiology. They believe in challenging traditional boundaries set for rare disease research.
 

About the opportunity
 
Join the global team as a Senior Clinical Research Associate, working towards a common goal of building close connections with patients and reaching breakthroughs that might have not appeared possible. The Senior CRA role requires collaboration with other team members and will be the main point of contact for global sites. The Senior CRA will be responsible for site recruitment, selection, initiation, monitoring, and closeout of the clinical sites.
 

Duties
 
  • Perform recruitment, selection, initiation, interim monitoring, and closeout visits
  • Ensure timely resolution of site issues identified and escalate the issues, as needed
  • Perform data checks in accordance with the Clinical Monitoring Plan
  • Train, support, and advise site staff about study-related material
  • Develop and execute a recruitment plan
  • Prepare and finalize monitoring visit reports
  • Timely collection and uploading of documents to the eTMF
  • Participate in investigator and selection and feasibility activities
  • Follow-up with quality issues, as appropriate
  • Prepare for audits and regulatory inspections
 
Skills and Experience
 
  • Bachelor’s degree in a scientific discipline or health care is preferred
  • Previous experience as a CRA
  • Minimum of 4 years of independent monitoring experience
  • Excellent knowledge of ICH-GCP guidelines and local regulations
  • Understanding of the drug development process
  • Strong written, verbal, and computer skills
  • Ability to work independently in remote environments
  • Experience in all study phases and in rare diseases is preferred
 
Culture
 
A company that focuses on serving patients first and improving employees, patients, and community members’ lives. They take pride in retaining talented employees by empowering the team, creating a sense of belonging, and valuing rewards and equity within the organization. 
 

How to Apply

Click apply or contact one of our consultants for a confidential discussion:
 
Brooke Slater, Sourcing Consultant on +61 2 8877 8738
 
Davina Ocansey, Senior Recruitment Consultant on +61 2 8877 8712

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