CRA - Poland

107816
  • Competitive
  • Krakow, Poland
  • Contract
CRA – Poland
Meet have been retained on an exclusively basis to work on a new CRA freelance contract position in Poland. With one of our strongest mid-size CRO clients.

This role only requires a small FTE commitment of 0.3 FTE. This is a perfect role for someone who has capacity to take on an additional small-scale, non-monitoring, short-term project to supplement their current projects.

These kinds of roles do not come up often and are never available for long, so if you think this role could be of interest to you, please do not hesitate to get in touch!

Job Responsibilities:
  • Establish and maintain effective, routine communications with study sites, providing timely study updates and support to sites.
  • Ensure site communications are documented and archived as per project requirements and SOPs.
  • Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues.
  •  Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
  • Assist study staff with maintaining the sponsor files during the life of the study.
  •  Assist in archiving at the end of study in accordance with relevant SOPs, policies and local regulatory.
  • Maintain up-to-date site information (including all contact details and distribution lists for reports and clinical supplies).
  • Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study:
  • Essential document collection, review, upload, maintenance, and close-out activities, ensuring that that sponsor, and investigator obligations are being met and follow applicable local regulatory requirements and ICH/GCP guidelines.
  • Perform Site Essential Documentation verification prior to upload into the eTMF.
  • Performs quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP.
  • Performs study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete.
  • Ensures protection of subjects, subjects’ rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.
  • Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs.
Prior Experience:
  • Successful completion of an approved Clinical Research / Monitoring course
  • Previous experience with Clinical Research Site Coordination or related fields (i.e., Regulatory Specialist) preferred.
  • Or
  • Previous experience in monitoring (i.e., In-House CRA/CTA/CMA) or equivalent experience) preferred.
Skills Required:
  • Professional attitude with good customer focus.
  • Effective communication skills: verbal/written/presentation.
  • Good interpersonal skills, including persuasion and influence.
  • Able to work independently as well as in a group.
  • Good time management, multitasking and execution skills.
  • Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Demonstrated proficiency in Microsoft Outlook, Word, Excel and PowerPoint.
  • Technically proficient enough to work in a remote environment and able to address minor technical challenges without support but will timely escalate to Information Technology Support for challenges beyond capabilities.
  • Capable of absorbing and applying knowledge gained through internal and external trainings on protocols assigned.
  • Knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
  • Effective knowledge of the drug development process.

Location: Poland
Contract: 3 months with possibility of extension.
FTE: 0.3
Salary: flexible dependant on experience

Applicants are assessed on an ongoing basis. Early application is encouraged.
If interested, please get in touch by:
email: emma.carlile@peoplewithchemistry.com or call: 020 3019 5985

 
Christopher Warman Lead Talent Partner

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