Clinical Data Coordinator

The Clinical Data Coordinator (CDC) reports to the Oncology Physicians Network (OPN) Director of Clinical Trials and the OPN Clinical Project Manager. The CDC is responsible for the proper handling and reporting of source data for clinical research studies, and assists with the planning and implementation of all components of clinical research protocols, including pre-and-post research activities, in and outside the clinical setting. The CDC is also responsible for regulatory compliance for each study, patient scheduling and support, and ensuring protocol procedures are completed accurately, safely, and in a timely manner.

· Coordinate the activation and maintenance of clinical protocols, including, organizing study files, review and completion of submissions, amendments, and adverse event reports/safety reports as required by the OPN Scientific Review Committee, sponsor IRBs and regulatory agencies

· Capture and track regulatory work and study support work for sponsor billing

· Prepare other study materials as requested. These study materials include, but are not limited to, study order sets, enrollment logs, case report forms and drug accountability logs

· Ensure drug accountability and management, and manage other pharmacy needs such as lab kits, equipment and clinical supplies

· Participate in sponsor clinical trial training at site initiation visits, investigator meetings, etc. Help to develop and implements appropriate training and tools for study team members.

· Assist physicians and clinical staff in the identification, recruitment and enrollment of patients and develop strategies to increase enrollment and to meet clinical research protocol eligibility requirements

· Ensure patient enrollment and research activities comply with the established protocols, and regulatory and monitoring agency standards

· Review laboratory and clinic procedures and evaluations regularly to ensure protocol compliance

· Participate in conducting surveys and quality of life interviews of patients in research protocols

· Act as a liaison between OPN and site physicians and key clinical staff, as well as serving as the point of contact for sponsor personnel (scheduling and participating in Site Qualification Visits, Site Initiation Visits and patient Cycle Visits as needed) for assigned protocol(s).

· Collaborate with principal investigators, study sponsors and OPN clinical research staff to resolve study queries

· Oversee data management for research projects. Develop and manage systems to organize, collect, report and monitor data collection

· Travel to OPN affiliated sites throughout Southern California may be required

· Perform other related duties and participates in special projects, as assigned.