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Clinical Research Associate (Polish, English speaking) – CRA-IDO-2024-4354

Website Achieva Group Limited

Manage the assigned CRO/Site(s) through regular contacts to ensure about:
• Site compliance with regulatory requirements and ethical standards throughout the tria
• Adequate enrolment and understanding of trial requirements
• Operate as a central communication link between the Clinical Pharmacology trial team
and the CRO/Site staff from the time of the IRB/IEC approval to the close-out visit, for
the assigned trials
• Manage all trial supplies, including (but not limited to) IMP and laboratory supplies,
from receipt to return or destruction, as appropriate
• Supervise biological samples shipment(s) from the CRO/Site to the bioanalytical
laboratory or central laboratory (when appropriate)
• Ensure timely eCRF completion, if applicable, and proactively identify any data
discrepancies by remotely reviewing the eCRF data in collaboration with the Data
Scientist
• Ensure that query resolution is completed in a timely manner and supervise database
lock in collaboration with the Clinical Pharmacologist and the Data Scientist
• Responsible for Trial Master File (TMF) and eTMF maintenance and inspection
readiness
• Ensure set-up and maintenance of the Investigator Site File
• Follow relevant quality control procedures to verify that the quality requirements for
the trial related activities are fulfilled
• If allocated, act as a Project Manager for trials assessed as having a low level of
complexity (e.g., Drug-Drug Interaction studies) as defined by the Head Clinical
Pharmacology
• If allocated, create, review, update, and provide input to CP and cross-functional QS
documents, to ensure compliance with Regulations, and Idorsia policies and
procedures

REQUIRED QUALIFICATIONS AND EXPERIENCE

Clinical Research Associate
• University degree in science or health-related discipline and/or degree in Nursing
• Minimum 1-2 years clinical research experience in a Contract Research Organization
(CRO) or Pharmaceutical Company with experience in monitoring on-site clinical trial
• Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements
• Understanding of drug development process

Senior Clinical Research Associate
• Minimum 4-5 years clinical research experience in a CRO or Pharmaceutical Company
with experience in monitoring on-site clinical trials including 2+ years’ experience in
monitoring early phase clinical trials (i.e., phase 0, 1, 2a)

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