Clinical Research Coordinator

JOB SUMMARY: 

The Clinical Research Coordinator, under the guidance and supervision of the Principal Investigator (PI) and the Clinical Research Nurse Coordinator, supports the integrity and quality of human subjects research (clinical trials), maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and MAHEC policies and procedures. The Clinical Research Coordinator supports the coordination and timely handling of the operational aspects of the clinical research protocol, including pre- and post-research activities, in and outside the clinical setting. The Clinical Research Coordinator helps implement clinical research projects, develops effective recruitment strategies, coordinates participant protocol treatment schedules, and participates in recruitment, screening, scheduling, testing, and data management for multi-faceted investigations. The Clinical Research Coordinator typically works on multiple research projects simultaneously. 

SPECIFIC RESPONSIBILITIES: 

In general: 

• Working as part of a multidisciplinary research team.  

• Understand and perform trial work in accordance with Good Clinical Practice (GCP) standards. 

• Support communication among interdisciplinary partners to support the development and execution of research and evaluation projects including MAHEC, Mission Health, and Community team members. 

• Provide operational feedback to managing staff 

Study Specific: 

• Assist the clinical trials team in assessing the feasibility of and planning for each study. 

• Perform clinical and administrative tasks in the implementation of clinical trials, which may include: 

• Recruiting, enrolling, and scheduling participants in compliance with regulatory and monitoring agency standards and institutional guidelines 

• In partnership with the Principal Investigator and Clinical Research Nurse Coordinator, execute the informed consent process, explaining studies to participants, answering questions, and documenting the consent process 

• Assure compliance with receiving, monitoring, and documenting the dispensing of investigational drugs and devices, as well as drug and device disposition at study close 

• Obtaining vital signs (e.g., blood pressure, pulse, oxygen saturation, weight), medical history, medication history, and other clinical data questionnaires  

• Performing medication reconciliation and baseline clinical assessment 

• Collecting biologic specimens 

• Performing laboratory specimen processing 

• Recording, scanning, uploading study-related documentation per protocol, procedural manual, and MAHEC protocols and policies 

• Obtaining