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ALOIS Solutions · 1 day ago

Clinical Research Coordinator

Palo Alto, CA

Contract

Onsite

Entry, Mid Level

ALOIS Solutions is striving to lead the biomedical revolution by fueling discovery and innovation to advance human health. They are seeking a Clinical Research Coordinator to perform duties related to the coordination of clinical studies, ensuring the safety and well-being of trial participants while documenting related data per protocols.

ConsultingHuman ResourcesStaffing Agency

Hiring Manager

Jaikumar J.

Responsibilities

Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out

Determine eligibility of and gather consent from study participants according to protocol

Assist in developing recruitment strategies

Coordinate collection of study specimens and processing

Collect and manage patient and laboratory data for clinical research projects

Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms

Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents

Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed

Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact

Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff

Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct

Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements

Participate in monitor visits and regulatory audits