Job Purpose:

The Research Coordinator prepares, directs, and coordinates clinical trial projects. This role is responsible for recruiting and screen studying of participants, as well as documenting and reporting on the daily operations of a study.

Primary Duties and Responsibilities:

• Conducts clinical trials according to FDA regulations and GCP/ICH guidelines.

• Monitors and maintains patient case reports, source documents, patient-related questionnaires, and research forms for accuracy per study protocol

• Screens and identifies potential patients for clinical trial participation based on eligibility criteria per the protocol and obtains informed consent from patients in compliance with IRB regulations

• Meet department goals, expectations, and volume metrics by enrolling study subject’s enrollment in each active clinical trial

• Collects specimens and inputs data and patient information into electronic data systems and source documents/charts

• Creates reports and documentation on each study protocol, schedule or assessments/activities, and data collection

• Retains all study records and source documents by sponsor requirements

• Responds to inquiries from study participants, sponsors, clients, and vendors. Proactively keeps patients informed of study protocols and safety information

• Coordinates SIV, IMV, and COV with study sponsor and applicable OI staff and providers

• Foster's relationship with the study sponsor, investigators, leaders, and colleagues ensures that clinical trials are efficiently executed and implemented

• Cooperates and collaborates with Investigators and Director relating to clinical trial compliance, monitoring safety and protection efforts relating to study subject participation

• Work well with Investigators and Sponsors in managing day-to-day activities, problem-solving, and communication of study protocol

• Maintains patient confidentiality/privacy protection, and integrity of study protocols.

• Stays informed of changes in applicable government/FDA regulations and GCP/ICH guidelines

• Pursues additional training and certification including but not limited to GCP Good Clinical Practice, ASCLS, and IATA

• Manages studies-related equipment, documents, investigational product, and clinical trial supplies

• Attends studies-related meetings, events, and seminars required in each protocol.

Competencies:

• Service: We align our actions and decision making with the organization’s guiding platform keeping our patients at the center of all we do.

• Change Agent: We support and contribute to positive change in the organization.

• Communication and Interpersonal Relations: We communicate honestly and with compassion to build connections with our patients and each other.

• Effectiveness: We take ownership of work, doing the right thing for our customer and doing it well.

Organizational Culture:

All OrthoIllinois employees focus on service by putting the mission, vision, and value statements into practice and using the guiding principles of Compassion, Respect, Trust, Integrity, Innovation, Education Fiscal Responsibility, Practice Independence, Accountability, and Empowerment to direct their interactions and decision making. Employees promote and model the service standards to create lasting impressions, extraordinary moments, exceptional on-stage experiences, and meaningful and compassionate connections.

Education and Experience Requirements:

• Bachelor's degree relevant field preferred

• Master’s degree in Medical Bio Technology preferred

• Experience in a clinical or research setting preferred

• Effective written and verbal communications

• Knowledge in MS Word/Excel/PowerPoint and Google apps (email, drive, calendar, excel, notepad, etc.)

Environmental/Working Conditions:

Working environment is in an office/clinic setting.

Physical/Mental Demands:

• Sit or stand for long periods of time, walk for periods of time, kneel, crawl, stoop and climb stairs.

• Requires lifting, carrying, or moving heavier objects (i.e. pushing or pulling up to 100 pounds and lifting and carrying up to 50 pounds

• Vision: Posses close, distant, peripheral and color vision and ability to adjust focus

• Hearing: ability to detect high pitch, soft or distant sounds

This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change as needs evolve.