Senior Clinical Research Associate I Flex

Chengdu, Sichuan
Permanent
Full-time

2 months ago

Job Description: Clinical Research Associate (CRA) Job DescriptionThe 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.
Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient. Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings. Participate, and may, with supervision, lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
May provide training or mentorship to more junior level CRAs. May perform training and sign-off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
As required, collaborate and build relationships with sponsor and other affiliates.

Qualifications

A 4-year BS (Bachelor of Science) degree or equivalent experience. Advanced degree is a plus.
At least 3 years of 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.About Us: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.About the Team:At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.At Novotech you will work alongside empowered teams with a shared commitment to success.

Strategic vs transactional mindset.

Ability to gain insights and make proactive decisions quickly.

Culture that fosters partnership and collaboration, where every voice is heard and valued.

Ongoing support from senior stakeholders and leadership team.

Novotech

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