Senior Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in Michigan, +1 more state.

📋 Description

• Oversee research operations at sites engaged in Worldwide’s clinical research initiatives.

• Identify potential sites for involvement in clinical research.

• Execute study start-up procedures, including the gathering of regulatory documents from sites.

• Assist in the negotiation of contracts and budgets.

• Train sites to accurately collect data and report any safety-related incidents.

• Manage site operations throughout the study maintenance phase.

• Conclude research activities at sites following study completion.

• Conduct study initiation visits (SIVs).

• Perform the majority of site management tasks remotely while ensuring informed consent, safety reporting, and adherence to regulatory standards.

⛳️ Requirements

• Outstanding interpersonal, verbal, and written communication skills in English.

• Exceptional organizational abilities with a keen eye for detail.

• Capability to work independently with minimal supervision.

• Proficient in Microsoft Office, CTMS, and EDC Systems.

• At least 5 years of experience as a Clinical Research Associate.

• Bachelor’s degree or a Nursing degree.

• Current experience in Oncology is mandatory.

• Experience with CAR-T is preferred.

• Fluency in both written and spoken English is essential.

• Preference for candidates located in the Midwest.

• Willingness to travel regionally is required.

🏝️ Benefits

• Comprehensive support for regulatory submissions, TMF management, and in-house CRAs to facilitate projects with significant site management requirements.

• Regular check-ins and coaching discussions with your Line Manager.

• Defined career trajectory and professional growth opportunities leading to Clinical Trial Manager positions.

• Access to the Executive Leadership team.

• Competitive benefits package tailored to location.