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About the Role
This role is responsible for building relationships with clinical trial personnel to ensure efficient trial management. It involves fostering customer relationships for timely project delivery, preparing essential documents, and supporting regulatory submissions. The position also focuses on participant recruitment, monitoring investigational sites according to GCP guidelines, ensuring data accuracy, and maintaining trial documentation.
Responsibilities
- Build relationships with Principal Investigators, study co-ordinators, pharmacists, and relevant site trial personnel for efficient trial management.
- Foster internal and external customer relationships to ensure efficient, timely, and productive project delivery.
- Prepare site essential documents and support ethics and regulatory submission/approval processes.
- Understand local and international regulatory requirements relevant to specific clinical trials.
- Ensure participant recruitment meets site targets and drive recruitment initiatives.
- Monitor investigational sites according to ICH GCP and the Clinical Monitoring Plan, including all visit types (selection, initiation, monitoring, close out, unblinded pharmacy, co-monitoring).
- Ensure participant rights and well-being are protected, including consent form checks, eligibility confirmation, protocol compliance, investigational drug compliance, and Adverse Event/SAE reporting.
- Verify trial data accuracy and completeness, ensuring CRF data and queries are completed and resolved per study timelines.
- Ensure study drug is appropriately stored, dispensed, accounted for, and reconciled.
- Ensure the project Trial Master File (TMF) is up-to-date, current, and complete.
- Support sites in being audit and inspection ready.
- Ensure all clinical trial management systems are current and up-to-date with relevant trial data.
- Provide written and verbal site updates, including monitoring visit reports, to the PM/LCRA.
- Collaborate on site payments, ensuring payment execution as per the Clinical Trial Agreement.
- Assist the PM with the development of study-related project plans and templates.
Requirements
- Graduate in a clinical or life sciences-related field.
- Relevant experience/qualifications in allied professions may also be considered.
- Good time management skills.
- Attention to detail.
- Ability to work well in a team.
- Computer literate.
- Experience of working in the research, pharmaceutical industry or a related field.
- CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience in other roles in the Clinical industry.
- CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
- CRA III: At least 4+ years of Clinical Research Associate experience in the Clinical industry.
Experience Level
- CRA II: Approximately 1-2 years
- CRA III: At least 2-3 years
- CRA III: At least 4+ years
Education Level
- Graduate in a clinical or life sciences-related field
Salary/Compensations
- $70,000 – 140,000
Benefits
- Flexible working options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
About the Company
- Novotech is proud to offer a great workplace.
- We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
- Our team members are passionate about what we do, but we understand work is only one of the things that is important to them.
- We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
- We are a Circle Back Initiative Employer and commit to respond to every application.
- We look forward to talking to you about working at Novotech.
Equal Opportunity
- Employer of choice for gender equality
- Inclusive work environment where everyone is treated fairly and with respect
- Looking for people who identify as LGBTIQ+, have a disability or have caring responsibilities