Clinical Research Associate II

4 weeks ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Job Summary

As a Clinical Research Associate II at Pharmiweb, you will be responsible for assessing the qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies.

Key Responsibilities

Evaluating, initiating, monitoring, and closing out clinical study sites
Documenting all activities in clear, comprehensive, and accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines
Ensuring that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements
Properly training/re-training site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial
Serving as the primary contact for site personnel, acting as liaison between site personnel and sponsor study team members
Developing patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines
Ensuring subjects' rights, safety, and well-being are protected
Ensuring compliance with the procedures to apply in the event of adverse events and serious adverse events
Evaluating the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion
Assisting and supporting data validation and data cleaning procedures to ensure timelines are met
Identifying, assessing, and resolving site performance, quality, or compliance problems and developing an appropriate intervention plan for the avoidance of redundant errors and deviations
Communicating with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance
Maintaining audit-ready clinical trial documentation. Collecting, reviewing, monitoring, and filing required regulatory documentation during study maintenance and at study closeout. Verifying investigator study records are reconciled with the contents of Sponsor files (Trial Master File)
Verifying the receipt, handling, accounting, storage conditions, and availability of study medications under investigation
Ensuring availability of non-clinical materials for sites
Developing strong site relationships and ensuring continuity of site relationships through all phases of the trial
Gaining an in-depth understanding of study protocols and related procedures

Requirements

Bachelor's degree in Life Sciences or related field
Minimum of 2+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock
Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials
Good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws, and other relevant local regulatory requirements
Good knowledge of concepts of clinical research and drug development
Strong working knowledge of EDC, IVRS, and CTMS systems
Proficiency in the use of Microsoft Office
Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific, and medical information
Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem-solving, attention to detail, and interpersonal skills
Works with a high-quality and compliance mindset
Possess a valid driver's license
Willing to travel and spend 8-10 days/month on site

What We Offer

At Pharmiweb, we offer a competitive salary, a range of additional benefits, and a diverse culture that rewards high performance and nurtures talent. Our benefits include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, a global Employee Assistance Programme, life assurance, and flexible country-specific optional benefits.

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