
Clinical Research Associate β Oncology, Hematology
Posted 6 days ago

Posted 6 days ago
This is a fully remote position, open to applicants in Czechia, +1 more country.
β’ Perform site qualification, initiation, interim monitoring, site management, and study closure visits.
β’ Offer mentorship and support to junior CRAs and site personnel as necessary.
β’ Record findings from site visits through detailed written reports.
β’ Evaluate, oversee, and instruct study site staff on adherence to protocols.
β’ Examine study subject safety data and informed consent forms.
β’ Carry out source document verification to ensure compliance, patient safety, and data integrity.
β’ Review Case Report Forms (CRFs) using both paper and electronic data capture systems, assisting sites in resolving data queries.
β’ Update documentation related to sites for organization in the Trial Master File (TMF).
β’ Ensure sites comply with the receipt, accountability, and return or disposal of investigational products.
β’ Conduct joint site visits for assessing or training other Clinical Research Associates.
β’ Exceptional interpersonal, verbal, and written communication abilities in English.
β’ Outstanding organizational skills with a focus on detail.
β’ Capability to work independently with minimal supervision.
β’ Proficient 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’ Bachelor's degree or an RN/BSN in Nursing.
β’ Required experience in Oncology and Hematology.
β’ Willingness to travel is a must.
β’ A supportive and collaborative work environment.
β’ Comprehensive assistance with regulatory submissions, TMF management, and in-house CRAs for projects needing extensive site management.
β’ A diverse and inclusive workplace.
β’ Equal employment opportunities.
Replimune
BeOne Medicines
Labcorp
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