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Danaher Corporation Sr Clinical Research Associate in Seoul, South Korea

RESPONSIBILITIES

  • Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

  • 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 as appropriate.

  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

  • 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.

  • Build awareness of features and opportunities of study to site.

  • Collaborate and liaise with study team members for project execution support as appropriate.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

  • Strong therapeutic and protocol knowledge as provided in company training

  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

  • Strong written and verbal communication skills including good command of English language

  • Strong organizational and problem-solving skills

  • Effective time management skills

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Candidates should have 3-5 years relevant work experience with BS degree, or 1-3 years of experience with MS or PhD years

  • Prior demonstrated experience in the successful design/execution of premarket clinical research studies is highly preferred.

PHYSICAL REQUIREMENTS

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech

  • Extensive use of keyboard requiring repetitive motion of fingers

  • Regular sitting for extended periods of time

  • Requires frequent travel to sites

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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