Are you ready to be a part of breakthrough research? The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements.
Primary Duties and
Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety. Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE’s and source documents.
Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process. Responsible for accurate and timely data collection, documentation, entry and reporting, including resolution of queries from sponsors or regulatory entities. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency as needed. Provides technical support for the preparation of grant proposals, publications, presentations and special projects. Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation.
Attend meetings and conferences related to research activities, including research staff meetings. Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participates in training and education of new research personnel. Responsibilities Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE’s and source documents. Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
Responsible for accurate and timely data collection, documentation, entry and reporting, including resolution of queries from sponsors or regulatory entities. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency as needed.
Provides technical support for the preparation of grant proposals, publications, presentations and special projects. Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation. Attend meetings and conferences related to research activities, including research staff meetings.
Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participates in training and education of new research personnel.
An Associate Degree/College Diploma is required. Bachelor's degree is preferred. Licenses and
Basic Life Support (BLS) from the AHA is required. Certification in clinical research (SoCRA or ACRP certification) is preferred. Experience and
Three (3) years of clinical research coordination or related experience is required. Maintains comprehensive knowledge of assigned research protocols to coordinate the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. Ability to use software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.).
Establishes effective working relationships with cross-functional team(s). Collaborates to solve problems and make decisions to achieve desired outcomes. Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.
Identifies and responds appropriately to internal and external customer needs utilizing available resources. Represents the company with external constituents.