Clinical Research Specialist / Professional in Clinical Research

Summary of Responsibilities
Will work closely with the Head of Clinical Operations by providing support to the management, assisting with the preparation, organization and follow-up of clinical study, site communications, and tracking actions, issues, and documents, at an international level. 

Requirements:

  • University degree in health care or life sciences, preferably MD and/or PhD
  • Experience in clinical research (pharma/biotech or CRO)
  • Appreciated: certified knowledge of GCP principles
  • Fluency in English 

Essential functions:

  • Support clinical vendors and sites identification, qualification and contracting
  • Be first line of contact to direct or address non-medical site questions
  • Perform study tracking to ensure that all study files and documents are accurate, current and complete
  • Perform essential document collection, review, maintenance and close-out activities, ensuring that sponsor obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs
  • Provide general support to the Head of Clinical Operations in order to manage the investigator sites and study data
  • Develop or contribute to newsletters for assigned studies based on information provided by Project Team
  • Maintain FAQ list and storyboard for assigned trial(s)
  • Confirm and track that all key site personnel have project specific training
  • Document site and sponsor contact and study interactions in a timely and professional manner
  • Assist with resolution of investigational site/data issues and queries
  • Liaise with project team members regarding study site issues
  • Provide quality review of documents related to clinical studies
  • Track submission to and approval from IRB, and other IND changes (including obtaining or creating documents related to these changes) correspondence, site changes
  • May provide study-specific direction, training and support to CRO staff as appropriate, and may provide guidance to other team members
  • Travel to sites and meetings as needed
  • Other duties as assigned and may change with change in studies/and needs of Selvita Clinical Development. 

 

Please send applications to:

E-mail: praca@selvita.com 

Human Resources, Selvita S.A., 14 Bobrzyńskiego St., 30-348 Krakow, Poland