
Clinical Research Associate β Oncology, Hematology
Posted Aug 25

Posted Aug 25
This is a fully remote position, open to applicants in Italy.
β’ Perform site qualification, initiation, interim monitoring, site management, and study close-out visits.
β’ Offer mentoring and support to less experienced Clinical Research Associates (CRAs) and site personnel as necessary.
β’ Record findings from site visits through comprehensive written reports.
β’ Evaluate, supervise, and train study site staff on adherence to protocols as required.
β’ Review safety information regarding study subjects and informed consent documents.
β’ Execute source document verification to ensure compliance, patient safety, and the accuracy of data.
β’ Examine Case Report Forms (CRFs) using both paper and electronic data capture systems, assisting sites with data query resolution.
β’ Provide necessary updates for site-related documentation to be filed in the Trial Master File (TMF).
β’ Ensure compliance at sites regarding the receipt, accountability, and proper return or destruction of investigational products (IP).
β’ Conduct accompanied site visits for the assessment or training of other CRAs when requested and appropriate.
β’ Outstanding interpersonal, verbal, and written communication skills in English.
β’ Exceptional organizational abilities with a keen eye for detail.
β’ Capability to work independently with minimal or no supervision.
β’ Proficiency in Microsoft Office, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) Systems.
β’ A minimum of 2 years of experience as a Clinical Research Associate.
β’ A four-year university degree or an RN/BSN in Nursing.
β’ Required experience in Oncology and Hematology.
β’ Willingness to travel is essential.
β’ A supportive and collaborative work environment.
β’ Extensive assistance with regulatory submissions, TMF management, and in-house CRAs for projects requiring significant site management.
β’ Equal employment opportunities for all candidates.
β’ A diverse and inclusive workplace culture.
β’ Exceptional experiences for employees.
Replimune
BeOne Medicines
Labcorp
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