Clinical Research Associate

1w1 week ago

Novotech

TW · Full-time · TWD 900,000 – TWD 2,000,000

About this role

The Clinical Research Associate ensures the rights and wellbeing of trial participants are protected. Reported trial data must be accurate, complete, and verifiable from source documents. The CRA serves as the primary contact between investigational sites, Novotech, and the sponsor.

As site relationship manager, the CRA ensures clinical trials follow ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs. This role builds relationships with principal investigators, study coordinators, pharmacists, and site personnel for efficient trial management. Responsibilities include driving site recruitment and preparing site-specific plans.

Day-to-day involves monitoring visits across all phases, including site selection, initiation, routine monitoring, close-out, and remote options per the clinical monitoring plan. Collaboration occurs with in-house CRAs, regulatory start-up associates for essential documents and submissions. Understanding local and international regulatory needs supports smooth project delivery.

Novotech offers an inclusive workplace treating everyone fairly with respect. Flexible working options, paid parental leave for both parents, and wellness programs support team members. Ongoing development programs foster passion in clinical research and biotech.

Requirements

Graduate in a clinical or life sciences-related field; relevant experience/qualifications in allied professions may be considered
Experience working in research, pharmaceutical industry or related field per job level
CRA II: minimum of 6 months of CRA independent monitoring experience
CRA III: 2+ years of CRA independent monitoring experience
SCRA: minimum of 4 years CRA monitoring experience
Good time management skills, attention to detail, ability to work well in a team, and computer literate
Full unrestricted working rights in Taiwan required; no sponsorship available

Responsibilities

Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel for efficient clinical trial management
Foster internal and external customer relationships for timely project delivery per study requirements
Collaborate with In-house Clinical Research Associate and Regulatory Start Up Associate to prepare site essential documents and support ethics/regulatory submissions
Understand applicable local and international regulatory requirements relevant to specific clinical trials
Ensure participant recruitment meets site targets and drive site engagement initiatives with site-specific recruitment plans
Conduct monitoring of investigational sites per ICH GCP, including site selection, initiation, monitoring, close-out, unblinded pharmacy visits, and co-monitoring, onsite or remote