Senior/Clinical Research Associate, Focused on Late Phase Research (Thailand- Bangkok)
Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. With a network of more than 30,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com
We are looking for suitable individuals to fill the position of :
Site Manager (Taiwan – Taipei)
- May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
- Execute assigned work efficiently and adhere to project timelines and financial goals
- Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
- May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
- Bachelor’s Degree preferably in life science, and 2 years of monitoring experience; or equivalent combination of education, training and experience
- Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Strong written and verbal communication skills in applicable languages, and business level command of English
- Good organizational, interpersonal and problem-solving skills
- Strong attention to detail
- Working time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
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