Clinical Trial Associate

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Organization: Barcelona ISGlobal
Job Type: Full-Time
Country: Spain
Experience: Mid Career (3-5 years)
Languages: English, Spanish
Category: Monitoring/Evaluation
Topic: Health/HIV
Application Deadline: 8. March 2021

Job Description

ISGlobal is seeking a highly motivated Clinical Research Associate/Monitor for a phase II/III adaptive multicentre clinical trial. The trial aims at evaluating the safety and efficacy of a new drug for the treatment and control of soil-transmitted helminths (STH). The overarching aim of the trial is to provide evidence to improve the effectiveness of current STH regimens in endemic countries. The trial is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and ISGlobal is the trial Sponsor. The trial stems from a strong collaborative effort of research and academic institutions and industry in Africa and Europe. The trial sites located in Kenya, Ethiopia and Mozambique.

Field research

  • Health / Medical sciences

Training and experience /Qualifications

  • University degree in health sciences
  • Training and experience in clinical trial monitoring
  • Knowledge of ICH guidelines and GCP
  • Knowledge of clinical trial study process
  • Excellent computer skills
  • Experience working in international and multi-cultural environment

Key Responsibilities and duties

  • Oversees and ensures that all human subject research activities performed are conducted according to the standards and guidelines for Good Clinical Practice (GCP), international and local regulations, trial protocol(s) and as per ISGlobal and study specific SOPs
  • Verify that:

– The rights and well-being of human subjects are protected

– The reported trial data are accurate, complete, and verifiable from source documents

  • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s)
  • Assess the qualification of investigative sites and training of site investigators before and during the course of the trial in collaboration with the study team
  • Assist in the development of trial tools and templates
  • Assist in the development and writing of clinical trial monitoring plans
  • Adhere to the monitoring plan, monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
  • Assist trial sites in submission of documents to the Ethics Committees and Regulatory Authorities
  • Set up the investigators file and ensure it is archived properly and accurately
  • Maintains the Trial Master File up to date and correct archiving
  • Perform trial initiation visit with study team
  • Monitor clinical trial progress through a combination of on-line and on site monitoring visits
  • Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
  • Review and verify that trial data is accurate and consistent with patient clinical notes and other source documentation (source data verification/review) either onsite or remotely
  • Correct serious adverse event (SAE) reporting according to trial specifications and ICH-GCP guidelines and local policies
  • Documentation of protocol deviations and all action plans taken
  • Reviews and reconciles the Investigator Site File with the Trial Master File for consistency before and during the trial and prior to site close out
  • Assist in preparation and participates in clinical trial meetings
  • Provides project status updates and reports to the PI and clinical trial team as required
  • Risk identification and escalation to the PI and clinical trial team
  • Timely query resolution
  • Trial drug (IP) accountability and compliance at the investigative site
  • Close clinical trials at investigative sites and manage all unused material, documents or products
  • Coordinates study drug supply from procurement to delivery on site, including the required documentation.
  • Other duties as assigned by PI

Skills

  • Proactive
  • Excellent clinical trial monitoring and organizational skills
  • Strong verbal and written communication
  • Problem solving skills
  • Ability to effectively work both as a team member and independently

Language level

  • Written and spoken English is required; knowledge of Spanish and Catalan a strong plus.

Conditions

  • Duration: 2 years
  • Starting date: 2nd quarter of 2021
  • Contract: Full time
  • Salary Range: Compensation for this position will be based on the applicant’s experience and qualifications.

Apply now

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