Job Title: Clinical Monitoring and Site Management Specialist
Are you a detail-oriented professional with a passion for clinical research? Do you have experience in monitoring and managing clinical trials?
This is an exciting opportunity to join our team as a Clinical Monitoring and Site Management Specialist. In this role, you will be responsible for monitoring and managing clinical trials, ensuring that they are conducted in accordance with regulatory requirements and good clinical practice (GCP) guidelines.
Key Responsibilities:
* Conduct site visits to monitor compliance with protocol and regulatory requirements
* Manage and coordinate clinical trial activities, including data management and reporting
* Collaborate with cross-functional teams to ensure successful trial execution
* Develop and implement risk-based monitoring plans to ensure trial integrity
* Conduct quality control checks on data and reports to ensure accuracy and completeness
Requirements:
* Bachelor's degree in a life sciences related field or a Registered Nursing certification
* Minimum 1-2 years of clinical monitoring experience
* Therapeutic experience in oncology essential
* Phase I experience essential
Skills and Qualifications:
* Basic medical/therapeutic area knowledge and understanding of medical terminology
* Ability to attain and maintain a solid understanding of GCPs and applicable regulations
* Good oral and written communication skills, with the ability to communicate effectively with medical personnel
* Good interpersonal skills
* Ability to remain flexible and adaptable in a wide range of scenarios
* 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
* Ability to work in a team or independently as required
* Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software
* Good English language and grammar skills
Benefits:
* Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues
* Flexibility: Balance your work and personal life with flexible arrangements
* Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave
* Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you
* Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development
About Us:
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Our company culture stands for integrity, intensity, involvement, and innovation. We are committed to creating a diverse and inclusive workplace where everyone can thrive. If you are passionate about clinical research and want to make a difference, we encourage you to apply.
Disclaimer: This job description has been created to reflect the requirements of the position. It does not include all duties, responsibilities, or qualifications associated with the role.
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