Research Coordinator I or II - Clinical Trials Office - MaineHealth Institute for Research

About the role

This Research Coordinator I or II will coordinate clinical research studies for the Barbara Bush Children’s Hospital Scholars Academy – MaineHealth, via the Clinical Trials Office, a division of the MaineHealth Institute for Research.

Responsibilities

• Support of The Barbara Bush Children’s Hospital Scholarship Academy (BBCH SA) members and their scholarly projects
• Aid in the development and writing of study protocols and other study specific documents
• Facilitate submissions to the MaineHealth Institutional Review Board for new studies, study amendments, reportable events and continuing review
• Coordinate study coordination including data entry, data management, regulatory oversight, and project management
• Grant-writing support, educational activities facilitation, data analysis support, and BBCH SA administrative tasks
• Teach new investigators how to use available resources to conduct their studies
• Identify, screen, and interview potential study subjects
• Explain the project and all associated benefits/risks and obtain necessary signatures
• Schedule subject assessments/visits as necessary
• Ensure the safety and protection of subjects enrolled in a research study
• Complete case report forms by obtaining, compiling, and maintaining necessary documentation
• Assist with facilitating inspections and audits from industry personnel and regulatory agencies
• Collaborate with other members of the Clinical Trials team to conduct study related tasks
• Coordinate and maintain regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent
• Comply with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials

Requirements

• Excellent communication, organization, and coordination skills
• Knowledge of the research process from study design to dissemination
• High degree of computer literacy including competency in Microsoft Office Suite, electronic data capture systems (e.g. RedCap), IRB submission platforms (e.g. Huron), and electronic health record systems (e.g. EPIC)
• Self-motivated
• Strong critical thinking skills and ability to independently resolve problems
• Working knowledge of data management software and procedures
• Strong understanding of Good Clinical Practice and Human Subjects Protection

Preferred Skills

• Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred or required within four years of start date

Benefits

The position offers benefits that support an individual's needs for today and flexibility to plan for tomorrow – programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.

Pay

Details on pay are not specified in the job posting.

Schedule

Details on the schedule are not specified in the job posting.