Clinical Research Associate Senior

1 month ago

Hong Kong, Central and Western District, Hong Kong SAR China Thermo Fisher Scientific Full time

Thermo Fisher Scientific is a leading company that enables its customers to make the world a better place. Our team of dedicated professionals works tirelessly to bring our mission to life, and we are looking for a Clinical Research Associate Senior to join us.

The estimated salary for this position is $80,000 - $110,000 per year, depending on experience.

Job Description

We are seeking a highly skilled and experienced Clinical Research Associate Senior to join our team. As a Clinical Research Associate Senior, you will be responsible for coordinating all aspects of clinical monitoring and site management processes.

Your primary responsibilities will include:

  • Conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation.
  • Managing procedures and guidelines from different sponsors and/or supervising environments.
  • Ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.
  • Developing collaborative relationships with investigational sites.

In addition, you will be responsible for:

  • Monitoring investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensuring data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
  • Assessing investigational product through physical inventory and records review.
  • Documenting observations in reports and letters in a timely manner using approved business writing standards.
  • Escalating observed deficiencies and issues to clinical management expeditiously and following all issues through to resolution.

You will also be responsible for providing trial status tracking and progress update reports to the Clinical Team and ensuring study systems are updated per agreed study conventions (Clinical Trial Management System, CTMS).

As a Clinical Research Associate Senior, you will have the opportunity to work in a dynamic and fast-paced environment, collaborating with cross-functional teams to deliver high-quality results.

Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
  • Previous experience comparable to 2+ years as a clinical research monitor.
  • Effective clinical monitoring skills.
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
  • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem-solving.
  • Ability to manage Risk-Based Monitoring concepts and processes.
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail, and the ability to perceive customers' underlying issues.
  • Effective interpersonal skills.
  • Strong attention to detail.
  • Effective organizational and time management skills.
  • Ability to remain flexible and adaptable in a wide range of scenarios.
  • Ability to work in a team or independently as required.
  • Good digital literacy: proficient knowledge of Microsoft Office and the ability to learn appropriate software.
  • Good English language and grammar skills.
  • Good presentation skills.
What We Offer

We offer a competitive remuneration package, annual incentive plan bonus, healthcare, and a range of employee benefits. At Thermo Fisher Scientific, we value our employees and offer outstanding career and development prospects.

We are an innovative, forward-thinking organization that stands for integrity, intensity, involvement, and innovation. Our mission is to enable our customers to make the world healthier, cleaner, and safer.

We believe in the importance of diversity and inclusion, and we strive to create a workplace where everyone feels valued and respected. Join us and start your story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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