Study Coordinator

Overview

The purpose of this position is to provide support, facilitate and coordinate daily clinical trial activities in clinical research studies as well as to oversee, in concert with PIs, activities of junior staff members of the team.

The position is responsible for coordinating with Principal Investigators to help ensure that clinical research and related activities are performed in accordance with federal regulations, University, and sponsoring agency policies and procedures.

Supervisory Authority

As directed.

Nature and Scope

Internal contacts include administrators, faculty, staff, and students within the College of Medicine, HU Hospital, and the University at large. External contacts include government agencies, sponsor representatives, vendors, visitors, officials, and the public.

Principal Accountabilities

• Assists the Principal Investigators (PI) in conducting a variety of clinical trial projects.
• Works under the guidance of the Clinical Trials Senior Lead Study Coordinator.
• Compiles data and assists in routine preliminary analyses and conducts data verification.
• Assists in preparing progress reports and presentations as required by the project.
• Assists in coordinating administrative support functions for program activities including data entry and word processing.
• Assists the PI in resolving data queries.
• Coordinates all aspects of assigned clinical trials from pre-study planning and regulatory submissions through successful completion of all subject visits, study documentation, and patient monitoring.
• Performs a quality control review of all source documents prior to each monitoring visit.
• Confirms IRB approval prior to study initiation.
• Monitors patients throughout the active treatment phase of the study; patient visits, providing investigators and clinic staff with treatment sheet and required treatment per protocol.
• Reports Adverse Events (AEs) and Serious Adverse Events (SAEs) to the PI and the Clinical Trials Senior Lead Study Coordinator.
• Performs other job-related duties as assigned.

Core Competencies

• Advanced knowledge of office and administrative practices and principles.
• Skill in the operation of computers, related software applications (MS Word, Excel, PowerPoint, Outlook).
• Expert in the application of clinical quality improvement principles and methods.
• Excellent written and verbal communication skills.
• Strong organizational and analytical skills. Ability to problem-solve and make decisions.
• Masterful multi-tasker, comfortable juggling multiple projects at once.
• Collaborative personality; able to work effectively with providers and multidisciplinary teams across departmental lines.
• Ability to exercise discretion and ensure a high level of confidentiality.
• Ability to communicate effectively orally and in writing with a diverse population.
• The ability to establish and maintain effective harmonious work relations with faculty, staff, students and the general public.

Minimum Requirements

• Bachelor's degree in healthcare or related field and 3+ years of clinical trials experience.
• Master's degree in healthcare or related field and 1+ years of clinical trials experience preferred.

Note: This position description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as may be required. The university has the right to revise this position description at any time. This position description is not construed as a contract for employment.

Compliance Salary Range Disclosure

Job details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industries: Online Audio and Video Media

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