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Lead Clinical Research Specialist
2 months ago
Are You Ready to Make an Impact?
GenesisCare CRO is a comprehensive oncology contract research organization focused on the development of radiopharmaceuticals. We collaborate with pharmaceutical and biotechnology firms to expedite drug development, foster cooperative research initiatives, bridge the translational divide, enhance diagnostic capabilities, and connect with a worldwide network of medical professionals.
We are seeking a Senior Clinical Research Associate to join our CRO division. This position is pivotal in overseeing clinical trials, ensuring compliance with relevant standard operating procedures (SOPs), regulations, and ICH guidelines.
Your Responsibilities Will Include:
- Actively participating in the project team to ensure efficient trial management.
- Conducting Site Qualification Visits: discussing protocols and study requirements with investigators and trial staff, verifying that site facilities and recruitment potential align with protocol standards, local regulations, ICH-GCP, and our SOPs.
- Assisting in feasibility assessments, site selection, and initiation activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions.
- Negotiating site budgets and aiding in the execution of site contracts with project management support.
- Executing Site Initiation Visits: training investigators and trial staff on protocols and data collection methods to guarantee accurate and complete patient data collection, adhering to local regulations, ICH-GCP, and our SOPs.
- Performing Interim Monitoring Visits: ensuring protocol adherence, verifying participant source data, managing investigational product accountability, and confirming that study procedures are executed in accordance with the protocol and ICF GCP.
- Conducting Site Close Out Visits.
- Overseeing all facets of study site management to ensure high-quality data collection.
- Maintaining electronic Trial Master File (eTMF) documentation.
- Tracking study progress in the Clinical Trial Management System (CTMS) promptly.
- Managing timely site payments.
- Potentially taking on project management-related tasks as needed.
We Are Looking For Candidates Who Have:
- A Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
- A minimum of 3-4 years of experience in monitoring clinical trials within a CRO, pharmaceutical, or biotechnology setting as a Senior Clinical Research Associate or Clinical Research Associate.
- Experience managing early-phase oncology trials is highly desirable.
- Familiarity with Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
- Comprehensive experience in site management from feasibility through to site close-out.
- Experience in contract negotiations is advantageous.
- Experience in preparing HREC submissions.
- A solid understanding of ICH-GCP requirements, particularly in relation to site management.
- A willingness to travel as necessary to fulfill job responsibilities.
Benefits of Joining GenesisCare:
- Take charge of your professional development with continuous learning opportunities.
- Engage in early site engagement from feasibility to startup, fostering relationships with sites.
- Collaborate directly with sponsors on assigned projects.
- Access to internal and external training and development programs.
- All employees and their families can utilize free, confidential support services, including financial, nutritional, and wellbeing coaching, as well as legal advice and counseling.
- Enhance your overall wellbeing through our Full Circle wellbeing initiative.
- Enjoy a variety of benefits, including discounts on Qantas membership, Anytime Fitness Gym membership, 12 weeks of paid parental leave, and Bupa discounts.
About GenesisCare
By becoming part of GenesisCare, you will join a forward-thinking and dedicated team of healthcare professionals and support staff, united by a shared mission: to create care experiences that yield the best possible life outcomes. Our journey towards improved cancer care has evolved into a passionate workforce of approximately 2,000 employees across 50 locations nationwide. Join us in designing better care and pursuing a career with purpose.
Covid-19 Vaccination Requirement
In accordance with public health directives, all GenesisCare employees must be fully vaccinated against COVID-19. Candidates must provide proof of vaccination and comply with public health requirements prior to employment consideration.
