Clinical Research Monitor

7 dagen geleden

Ede, Gelderland, Nederland Thermo Fisher Scientific Voltijd

Job Summary

Thermo Fisher Scientific is seeking a highly skilled Clinical Research Monitor to join our team. As a Clinical Research Monitor, you will be responsible for conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation. You will also be responsible for 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.

Key Responsibilities

  • Monitor 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.
  • Ensure 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.
  • Document 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.
  • Participate in investigator meetings as vital, identifying potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Perform trial close out and retrieval of trial materials, ensuring that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required, ensuring study systems are updated per agreed study conventions.
  • Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
  • Respond to company, client and applicable regulatory requirements/audits/inspections, maintaining & completing administrative tasks such as expense reports and timesheets in a timely manner.
  • Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
  • Contribute to other project work and initiatives for process improvement, as required.

Requirements

  • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
  • Valid driver's license where applicable.
  • Proven clinical monitoring skills, demonstrated understanding of medical/therapeutic area knowledge and medical terminology, demonstrated ability to attain and maintain a solid understanding 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, good 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.
  • Good organizational and time management skills, effective interpersonal skills, attention to detail, 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: solid knowledge of Microsoft Office and the ability to learn appropriate software.
  • Good English and Dutch language and grammar skills, good presentation skills.

What We Offer

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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