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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 advancement of radiopharmaceuticals. We partner with pharmaceutical and biotechnology firms to expedite drug development, foster collaborative research, bridge the translational divide, enhance diagnostic capabilities, and connect with a global network of medical professionals.
We are seeking a Senior Clinical Research Associate within our CRO division, with opportunities available in various locations. This position is pivotal in overseeing clinical trials, ensuring compliance with relevant SOPs, regulations, and ICH guidelines.
Your Responsibilities Will Include:
- Collaborating with the project team to facilitate effective trial management.
- Conducting Site Qualification Visits: discussing the protocol and study requirements with Investigators and trial staff, ensuring site capabilities align with protocol specifications, local regulations, ICH-GCP, and GenesisCare CRO's 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 Manager support.
- Executing Site Initiation Visits: training Investigators and trial staff on the protocol and data collection methodologies to ensure accurate and complete patient data collection in compliance with local regulations, ICH-GCP, and GenesisCare CRO's SOPs.
- Performing Interim Monitoring Visits: ensuring protocol adherence, verifying participant source data as per the monitoring plan, and conducting Investigational Product accountability, while meeting with site personnel to confirm study procedures align with the protocol and ICF GCP.
- Conducting Site Close Out Visits.
- Overseeing all aspects of site management to guarantee high-quality data.
- Maintaining eTMF filing.
- Tracking study progress in the Clinical Trial Management System (CTMS) promptly.
- Managing timely site payments.
- Possibly taking on Project Manager-related tasks as needed.
Qualifications We Are Looking For:
- 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 EDC & CTMS.
- Comprehensive knowledge of site management processes from feasibility and start-up to close-out.
- Experience in contract negotiations is advantageous.
- Proficiency in preparing HREC submissions.
- Understanding of ICH-GCP requirements, particularly in relation to site management.
- Willingness to travel as required for the role.
Why Choose GenesisCare?
- Take charge of your professional growth and learn continuously.
- Engage in early site engagement from feasibility to startup, fostering relationships with sites.
- Work directly with sponsors on assigned projects.
- Access to internal and external training and development opportunities.
- All employees and their families benefit from free confidential support services, including financial, nutritional, and wellbeing coaching, legal advice, and counseling.
- Enhance your overall wellbeing with our Full Circle wellbeing program.
- Enjoy a range of benefits, including discounts on Qantas membership, Anytime Fitness Gym, 12 weeks of paid parental leave, and Bupa discounts.
About GenesisCare
By becoming part of GenesisCare, you will join a dynamic 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 commitment to improving cancer care has evolved into a passionate workforce of approximately 2,000 employees across numerous locations. Join us in our mission to design better care and pursue a meaningful career.
Covid-19 Vaccination Requirement
In accordance with Public Health Orders, all GenesisCare employees must be fully vaccinated against COVID-19. Candidates must provide proof of vaccination and comply with the Public Health Order requirements prior to employment consideration.
