Ref #: 28546

Employment type: Permanent - Full-Time

Location: Taipei, Taiwan

Posted: 21-Apr-2021


If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Clinical Research Associate I to work closely with our client, a leading pharmaceutical company.

As a Study Start Up Specialist (SSU) you will will be focusing only on HA & EC submission conduct, no involving site contract, the submission timeline/ strategy still owned by the Project Manager instead of SSUA itself.

You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.

Key responsibilities
• Independently manages multiple country, study and site level deliverables during start-up and maintenance both within company and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones.
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the company internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.
• Prepare country Informed Consent Form (ICF) and manage country ICF template.
• Review and approval of Site ICFs.
• Review and approval of Clinical Trial Package (CTP) documentation.
• Update national registries as applicable.
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
• When applicable, conduct drug/IMP label review & translation.
• Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal.
• May support the collection and distribution of documents from / to sites including obtaining insurance certificates.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.

Required experience and qualifications
* Mainly focus on TFDA/IRB submission.
* 2-3 years of experience is required.

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.