Summary

The Research Coordinator II is responsible for implementing and coordinating the day to day activities of clinical research trials or research protocols for the Department of Pediatrics, Research Resource Office (RRO). The Research Coordinator II assists with patient enrollment, data entry, reporting, collection and transcription of research patient data, and reporting to study sponsor. Responsibilities directly impact clinical research by ensuring Investigators follow best clinical practices and patient safety protocols are observed.

Job Duties

• Prepares documentation necessary to obtain initial and continued approval for the specific clinical trials and research protocols. 
• Reviews protocol documents, including abstracts, text, and informed consent for relevant information.
• Prepares study related tools and assists investigators in reviewing treatment and visit order sets.
• Conducts research subject recruitment, screening, and enrollment. Participates in subject consent process.
• Conducts subject research study education and interacts with patients to clarify data, within scope of practice.
• Evaluates and analyzes clinical research data as appropriate, and maintains research activity logs.
• Participates in monitoring, audits and follow-up in coordination with other research staff. 
• Collaborates with physician, mid-level practitioners, research nurses and data managers to document patient care.
• Ensures conduct of assigned studies is in accordance with good clinical practice, federal regulations and institutional policies. 
• Interacts with outside sponsors and/or coordinating sites as required to facilitate protocol activities.
• Submits Serious Adverse Event reporting and follow-up as needed.
• Processes, stores, and ships blood or biological specimens as outlined per study protocols and associated lab or procedural manuals, in accordance with IATA Guidelines.
• Performs research related procedures with appropriate credentialing and training, as required by the clinical trial or research protocol: (eg: blood draw, ECG, EEG, Questionnaires and rating scales) 
• Utilizes the Clinical Trial Management System (CTMS), Regulatory Affairs, Billing and Invoicing services of the Research Resource Office.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• One year of relevant experience.

Preferred Qualifications

• Prior experience working in an academic research setting with clinical research grants and protocols strongly preferred.
• Ability to understand and manage the complexities of clinical trials and research protocols, including issues related to informed consent, access to data, and conflict of interest preferred.