Clinical Research Associate-Shanghai

Novotech

Shanghai
Permanent
Full-time

13 days ago

Job Description:Description for Internal Candidates

Contribute comments/input in the development of Protocol, Informed Consent Form

(ICF), Case Report Forms (CRF) and other project related documents.

Performs 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. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses 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.

Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

Participates, and may, with supervision, lead, global clinical monitoring/project staffmeetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

Provides guidance at the site and project level towards audit readiness standards and supports 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.

About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.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: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech

Apply Now