Clinical Research Coordinator - Manager

PURPOSE:

To coordinate activities and perform duties and procedures related to the start-up, conduct and close-out phases of clinical pharmaceutical and device research protocols. To obtain clean, objective and accurate data within sponsor timelines while following applicable SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonization (ICH), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements.

RESPONSIBILITIES:

• Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets generated by the sponsor;
• Schedule and conduct patient visits according to protocol requirements and timelines;
• Account for clinical trial materials (i.e. CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study;
• Read, understand and is able to accomplish protocol specified patient visits and procedures;
• Maintain accurate and complete written source documentation of patient visits and protocol related activities;
• Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary;
• Obtain patient informed consent according to federal regulations, GCPs and IRB requirements;
• Is creative and diligent in recruiting qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines;
• Maintain ongoing communication with Team Lead, CRCs, Director, Clinical Operations, Principal Investigator and other persons assisting with the trial and documents these communications according to protocol requirements and policies;
• Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to supervisor, Principal Investigator and/or Sub-Investigator;
• Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs;
• Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with, between company and sponsors, and between company and other entities, as well as HIPAA regulations;