Senior Clinical Research Associate – Oncology, Hematology, CNS

This is a fully remote position, open to applicants in Poland.

📋 Description

• Perform site qualification, initiation, interim monitoring, site management, and study close-out visits.

• Provide mentorship and guidance to less experienced CRAs and site personnel when necessary.

• Record findings from site visits through written reports.

• Evaluate, oversee, and train study site personnel on adherence to study protocols.

• Review safety information of study subjects and informed consent forms.

• Carry out source document verification to ensure compliance, patient safety, and data integrity.

• Review Case Report Forms (CRFs) utilizing paper or electronic data capture systems.

• Assist sites in resolving data queries.

• Update site-related documentation for inclusion in the Trial Master File (TMF).

• Ensure compliance at sites regarding the receipt, accountability, and return or destruction of investigational products.

• Conduct joint site visits for the assessment or training of other CRAs as requested and deemed appropriate.

⛳️ Requirements

• Exceptional interpersonal, oral, and written communication skills in English.

• Outstanding organizational abilities with a keen attention to detail.

• Capability to work independently with minimal supervision.

• Proficient in Microsoft Office, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) systems.

• A minimum of 2 years of experience as a Clinical Research Associate.

• A bachelor's degree or a Registered Nurse (RN) / Bachelor of Science in Nursing (BSN).

• Required experience in Oncology, Hematology, and Central Nervous System (CNS) fields.

• Willingness to travel is essential.

🏝️ Benefits

• Assistance with regulatory submissions, TMF management, and in-house CRAs for projects with significant site management demands.

• A supportive and team-oriented work environment.

• Accessible and hands-on leadership.

• Cohesive and collaborative teams.

• A diverse and inclusive workplace.

• Equal employment opportunities for all.

• Exceptional experiences for employees.