Clinical Research Associate - Brisbane

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 (CRAII - CRAIII)
Location: Hybrid (Flexible working hours)
Company: Novotech

About Us:
Novotech is a leading Asia-Pacific biotech specialist Contract Research Organization (CRO) with offices across 11 geographies. We provide clinical development services across all phases of clinical trials, including feasibility assessments, regulatory submissions, data management, safety solutions, and project management. Novotech has extensive experience in over 3,700 clinical projects, including Phase I to Phase IV trials and bioequivalence studies. We are ISO 27001 and ISO 9001 certified, ensuring the highest IT security and quality standards for patients and biotechnology companies globally.

Scope of Role:
The Clinical Research Associate (CRAII - CRAIII) ensures the protection of trial participants' rights and well-being while verifying the accuracy, completeness, and verifiability of reported trial data from source documents. As the primary contact between Investigational Sites, Novotech, and the Sponsor, the CRA is responsible for managing site relationships and ensuring compliance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Responsibilities:

Act as the primary site relationship manager, ensuring clinical trials are conducted in accordance with ICH GCP and regulatory guidelines.
Build and maintain relationships with Principal Investigators, study coordinators, and site personnel to ensure efficient trial management.
Monitor investigational sites across all phases of clinical trials, including Site Selection, Site Initiation, Monitoring, and Site Close Out, ensuring compliance with protocols and regulatory requirements.
Provide support for ethics and regulatory submissions and approvals.
Manage participant recruitment to meet site targets, including driving site recruitment and engagement initiatives.
Foster collaboration with internal teams, ensuring focus on efficient, timely project delivery.
Ensure the accuracy, completeness, and verifiability of trial data from source documents.
Conduct site monitoring visits both onsite and remotely as per the Clinical Monitoring Plan (CMP).

Minimum Qualifications & Experience:

Graduate in clinical or life sciences-related fields (or relevant qualifications in allied professions).
CRA II: Minimum 6 months of independent CRA monitoring experience.
CRA III: 2+ years of independent CRA monitoring experience.
Must have unrestricted working rights in New Zealand.

What We Offer:

Hybrid working arrangements with full flexibility in working hours.
An inclusive, diverse work environment with a focus on work-life balance.
Paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities.
We are an equal opportunity employer, supporting individuals from all backgrounds, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities.

Why Novotech:
Novotech offers a supportive and inclusive work environment, allowing for professional growth and work-life balance. We are passionate about advancing clinical research and biotechnology, providing our team with the flexibility and support they need to succeed.

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Clinical Research Associate - Brisbane

Job Description

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