Clinician to Cra - Barcelona, España - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Empresa verificada
Barcelona, España

hace 1 mes

Isabel García

Publicado por:

Isabel García

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Descripción
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.


Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.

Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.


This role is within our FSP (Functional Service Partnership) division, which is a partnership between Thermo Fisher Scientific and one of our strategic clients.

In this position, employees will be assigned to work with a specific client to carry out the responsibilities outlined below.


Discover Impactful Work:


A day in the Life:


  • Monitors investigator sites with a riskbased monitoring approach: applies root cause analysis (RCA), critical thinking and problemsolving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV and CRF review as applicable through onsite and remote monitoring activities.
  • Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  • Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
  • Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and followup on findings as applicable.
  • Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Performs trial close out and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Conducts onsite file reviews as per project specifications.
  • Provides trial status tracking and progress update reports to the team as required.
  • Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts.
  • Responds to company, client and applicable regulatory requirements/audits/inspections.
  • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
  • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required.

Keys to Success:

Education

  • Bachelor's degree in life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Experience

  • Comprehensive experience as a clinician in a healthcare environment (comparable to at least 3 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment.
  • Expertise in a therapeutic area including, but not exclusive to oncology, medical surgery, pulmonology, or critical care (comparable to at least 2 years).
  • OR 18+ months experience in clinical research as
    _Nurse, Pharmacist, Site Coordinator_, or similar role
In some cases, the combination of education, training and experience provides the individual with the requir
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