Clinical Research Coordinator -Center For Advance Clinical Research

By joining our team, you'll be part of our life-changing Mission and Vision. You'll work in a truly inclusive environment where diversity and equity are championed through words and actions. You'll contribute to an innovative culture that is second to none, one that embraces curiosity, discovery and compassion. You'll play a role in something that's never been done before as we integrate science and clinical care to help patients achieve better, faster outcomes - as we Advance Human Ability, together.
Job Description Summary
The Clinical Research Coordinator is responsible for operational management of Clinical Research projects at Shirley Ryan AbilityLab. Oversees Clinical Research project objectives, determines appropriate Clinical Research participant recruiting strategies, interviews potential Clinical Research participants, conducts the informed consent process, coordinates all Clinical Research activities according to study protocols, manages all Clinical Research data according to GCP and sponsor requirements, and functions as project manager on an as-needed basis. Will coordinate activities for multiple projects at any given time.
The Clinical Research Coordinator will consistently demonstrate support of the Shirley Ryan AbilityLab statement of Vision, Mission and Core Values by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others with whom there is contact at or in the interest of the institute.
The Clinical Research Coordinator will demonstrate Shirley Ryan AbilityLab Core Attributes: Communication, Accountability, Flexibility/Adaptability, Judgment/Problem Solving, Customer Service and Core Values (Hope, Compassion, Discovery, Collaboration, & Commitment to Excellence) while fulfilling job duties.
Job Description
The Clinical Research Coordinator will:

• In coordination with a given study's principal investigator, identifies optimal recruiting strategy for assigned Clinical Research studies, which may include extracting data from medical records and research subject databases. Executes recruiting strategy to maximize study enrollment.
• Prepares, submits, and maintains all study-related regulatory documentation, including institutional review board (IRB) submissions, study binders, and completed consent forms.
• Guides research participants through the informed consent process.
• Coordinates all personnel and resources necessary to complete the objectives of assigned Clinical Research projects in accordance with study protocols.
• Manages all data associated with assigned Clinical Research projects, including original source documents and data entered into electronic case report forms. Interacts with study sponsors or contract research organizations to address all data inquiries
• Assists in review of study contracts and budget preparation. Assist in drafting manuscripts for publication and scientific presentations when appropriate.
• Serves as a member of the Clinical Research team, screen subjects for participation, performing screening evaluations, and coordinate activities with all involved clinical departments.
• Hosts sponsors or contract research organizations during study specific visits including but not limited to site qualification visits, site initiation visits, monitoring visits, and study closeout visits.
• Performs all other duties that may be assigned in the best interest of the Shirley Ryan AbilityLab.

Reporting Relationships

• Reports to the Executive Director, Innovation & Clinical Research.

Knowledge, Skills & Abilities Required

• Bachelor's degree in a behavioral or biological science.
• Completion of a Certified Clinical Research Coordinator (CCRC) training program or equivalent is highly desirable.
• Five years' experience working as a Clinical Research Coordinator or similar Clinical Research role.
• Strong working knowledge of good clinical practice (GCP).
• Must have excellent attention to detail and autonomous work habits. Strong interpersonal and organizational skills are essential to succeed as a member of a research team, to exchange ideas, to work closely with numerous professional organizations and facilities and to plan and coordinate project completions.
• Strong written communication skills are vital to this role, with experience in technical and medical writing preferred.

Working Conditions

• Normal office environment with little or no exposure to dust or extreme temperature.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Equal Employment Opportunity
ShirleyRyan AbilityLab is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.