Lead Clinical Research Coordinator - Oncology

Position Summary

Lead Clinical Research Coordinator serves as primary resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the cancer Clinical Trials Office.

Responsibilities

• Plans, implements & oversees daily conduct of protocol activities;
• Serves as primary reviewer of patient records to assess & identify patients who meet criteria for participation in research studies;
• Recruits, interviews & promotes study to eligible patients; educates patients and families of purpose, goals, & processes of clinical study;
• Leads patient enrollment activities & ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements;
• Facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing;
• Monitors patients for adverse reactions to study treatment or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care;
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies;
• Participates in collecting, extracting, coding, & analyzing clinical research data;
• Monitors & ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations;
• Participates in planning and preparing for external compliance, quality assurance & control reviews;
• Participates in development of new research protocols and contributes to planning of goals to meet study requirements;
• Works closely with principal investigators upon awarding of new protocols and recommends team assignments;
• Assists with preparation and submission of publications, research reports, and grant proposals;
• Trains, mentors and supervises staff.

Job Requirements

Bachelor’s Degree in biological sciences, health sciences or other relevant field or an equivalent combination of education and experience required; three to five years’ experience in a clinical research capacity conducting clinical research studies required; experience in a progressively responsible management capacity in a medical research environment preferred; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required; computer skills required.