Sr Cra Ii ( Home Based Sponsor Dedicated- Melbourne/ Sydney)

5+ years

Not Disclosed

Remote, USA

10 Dec. 18, 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: Senior Clinical Research Associate II (Home-based, Sponsor Dedicated - Melbourne/Sydney)
Location: Australia – Home-Based
Job ID: 24006809
Updated: December 15, 2024

Job Description:

Syneos Health is seeking a Senior Clinical Research Associate II (Sr. CRA II) to join our team in a home-based, sponsor-dedicated role in Melbourne/Sydney, Australia. As a Sr. CRA II, you will perform clinical site management and monitoring activities, ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and study protocols. You will be responsible for site qualification, initiation, monitoring, and close-out visits, both remotely and on-site, driving high-quality clinical trials and ensuring the safety and integrity of clinical data.

Key Responsibilities:

Conduct site qualification, initiation, monitoring, management, and close-out visits (on-site and remote).
Ensure compliance with regulatory, ICH-GCP, and protocol standards.
Perform Source Document Review and Case Report Form (CRF) data verification.
Resolve data queries and provide guidance to site staff on protocol adherence.
Oversee investigational product (IP) handling, storage, and distribution.
Maintain Investigator Site File (ISF) and ensure timely documentation in the Trial Master File (TMF).
Support patient recruitment, retention, and awareness strategies.
Manage site communications and ensure project timelines and objectives are met.
Act as a liaison between the site and project team, ensuring site staff is trained and compliant.
Participate in Investigator Meetings, sponsor meetings, and clinical monitoring staff meetings.
Provide audit readiness guidance and support preparation for audits.
Mentor and train junior CRAs, and support site management across the study lifecycle.
For Real World Late Phase (RWLP), additional responsibilities include site support, data collection, and involvement in bid defense meetings.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Proficiency in computer skills and new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel for monitoring visits.
Moderate critical thinking and problem-solving skills.

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Sr Cra Ii ( Home Based Sponsor Dedicated- Melbourne/ Sydney)

Job Description

Job Description:

Key Responsibilities:

Qualifications:

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