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.
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
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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