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Clinical Research Associate - Taiwan

Employer
OPIS
Location
Taiwan (TW)
Salary
Salary + benefits
Start date
11 Jan 2023
Closing date
10 Feb 2023

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

We are a full-service CRO, expanding world-wide, offering stable career prospects and a variety of engaging projects to work on. Opis has been on the market for over two decades, therefore the career opportunities are stable and fruitful. We are committed to offering high-quality services, at an international level and we don`t like cutting corners!

Our extensive expertise can cover all phases of drug related trials in all the therapeutic areas as well as clinical investigations for medical and diagnostic devices, Investigator Initiated Trials (IITs), and compassionate use programs.

Due to our ongoing global expansion, we have a great opportunity for an experienced CRA to join our growing team and work from home in Taiwan. This role is a permanent remote position, with 2-3 days/ week visiting sites; which promises real career progression and fantastic networking opportunities, world-wide.

You are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.

Main tasks & responsibilities:

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
  • Perform visits remotely according to foreseen applicable procedures and timeframes
  • Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
  • Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures
  • Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Requirements:

  • Life Science Degree
  • 2+ years experience as a CRA in another CRO, monitoring Clinical Trials
  • In depth knowledge of ICH GCP principles
  • Experience with phases II and III of CT
  • Ability to travel nation-wide
  • Fluent English

Benefits:

  • Salary + performance bonus
  • Annual leave
  • Private Healthcare
  • VipDistrict discounts
  • Flexible hours
  • WFH

Company

OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

 

Company info
Website
Telephone
0039 362 6331
Location
Palazzo Aliprandi
Via Matteotti 10
Desio (MB)
Lombardy
20832
Italy

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