The Clinical Research Associate (CRA) is responsible for managing and monitoring the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP), and applicable Project Management Plan (PMP) and local regulatory requirements.
Job Responsibilities- Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
- Evaluate potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites.
- Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
- Assist PM in start-up meetings. Participate in investigator meetings as necessary.
- Prepare and manage the clinical trial agreements with investigators/sites.
- Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
- Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
- Monitor and report the project status at the sites in a timely manner.
- Act as the key contact person for communication between the sites and study team.
- Prepare, arrange and conduct the training of site personnel.
- Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
- Prepare monitoring reports according to the SOP.
- Assist the investigator for auditing/inspection of the project.
- Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.
- A 4-year BS (Bachelor of Science) degree or equivalent experience. Advanced degree is a plus.
- At least 2-year experience in a clinical research environment.
- Good command of written and spoken English or another second language.
- Good organization and communication skills.
- High attention to detail and accuracy.
- Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs.
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 support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
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.
Novotech is a global full-service clinical Contract Research Organization (CRO).
Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
