Clinical Research Associate - Sydney

2+ years

Not Disclosed

Remote

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate II / III - Oncology
Location: Hybrid (Flexible Working Hours)
Company: Novotech

About Us:
Novotech is a leading Asia-Pacific biotech specialist Contract Research Organization (CRO), with a presence in 11 geographies. We offer clinical development services across all trial phases and therapeutic areas, including feasibility assessments, regulatory submissions, data management, and medical monitoring. With extensive experience in over 3,700 clinical projects, Novotech is committed to providing top-tier support to biopharmaceutical clients conducting trials globally. We are ISO 27001 and ISO 9001 certified, ensuring the highest standards of IT security and quality management for patients and biotech companies.

Position Overview:
The Clinical Research Associate (CRAII/CRAIII) in Oncology is responsible for protecting the rights and well-being of clinical trial participants, ensuring that reported trial data is accurate, complete, and verifiable from source documents. As the primary contact between Investigational Sites, Novotech, and Sponsors, the CRA plays a crucial role in ensuring clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs. This position offers hybrid working arrangements with full flexibility in working hours to promote work-life balance.

Responsibilities:

Develop and maintain relationships with Principal Investigators, study coordinators, pharmacists, and site personnel to ensure efficient and smooth management of clinical trials.
Foster both internal and external relationships, ensuring timely and productive project delivery in line with study requirements and timelines.
Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare site essential documents and support the ethics and regulatory submission and approval processes.
Understand applicable local and international regulatory requirements and ensure compliance with them for each clinical trial.
Ensure participant recruitment meets site targets, drive recruitment and engagement initiatives, and update site-specific recruitment plans as necessary.
Conduct monitoring visits (on-site or remote) in compliance with ICH GCP guidelines, including Site Selection, Site Initiation, Site Monitoring, and Site Close Out.
Perform unblinded pharmacy visits and co-monitoring visits as part of the clinical trial process.

Minimum Qualifications & Experience:

Graduate in a clinical or life sciences-related field (relevant qualifications or experience in allied professions will also be considered).
CRA II: Minimum of 1 year of independent monitoring experience in Oncology.
CRA III: Minimum of 2 years of independent monitoring experience in Oncology.
Strong time management skills, attention to detail, team collaboration abilities, and computer literacy.
Full, unrestricted working rights in Australia (sponsorship not available).

What We Offer:

Hybrid working arrangements with flexible working hours to maintain work-life balance.
A diverse and inclusive workplace committed to gender equality and employee well-being.
Paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing professional development.
We welcome applications from LGBTIQ+ individuals, people with disabilities, and those with caring responsibilities.

Why Novotech:
Novotech offers a supportive and inclusive environment for professionals passionate about clinical research and biotech. Our flexible working culture promotes a healthy work-life balance, and we are committed to providing opportunities for growth and development.

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Clinical Research Associate - Sydney

Job Description

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