Clinical Research Associate jobs in Janesville, WI

Department: Research Reports To: Director of Clinical Research

FLSA: Non Exempt

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 using good clinical practice
• Monitors and maintains patient case reports and forms for accuracy and in accordance with FDA regulations
• Screens and identifies potential patients for clinical trial participation and obtains informed consent from patients in compliance with IRB regulations
• Collects specimens and inputs data and patient information into electronic systems
• Creates reports on each study, including notes on protocols, workload, and data collection
• Responds to inquiries from study participants and proactively keeps patients informed of study progress
• Coordinates SIV with study sponsor and applicable OI staff and providers
• Fosters relationship with study sponsor by coordinating SIV and engaging in sponsor monitoring visits
• Maintains patient confidentiality
• Stays informed of changes in applicable government regulations and FDA guidelines.
• Pursues additional training and certification including but not limited to GCP Good Clinical practice, ASCLS, and IATA
• Manages studies related equipment and supplies
• Attends studies related meetings, events, and seminars

Competencies:

• Planning and Organizing: Manages a high volume of tasks at one time, prioritizing workload while maintaining a high level of attention to detail
• Decision Making: Collects and reviews relevant data before acting balancing risk and rewards of options, encourages input from other subject matter experts, able to adjust opinions and recommendations based on new information, and objectively evaluates decisions after they have been made
• Attention to Detail: Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently
• Communication: Actively listens, interprets verbal and nonverbal cues, and seeks to understand; presents information clearly both verbally and written with the goal to inform and care for patients; able to adjust presentation as needed for audience
• Adaptability: Maintains composure in a fast-paced environment, managing changing priorities and adjusting response appropriately to achieve goals; responds to change with a positive attitude and willingness to learn new ways to accomplish work activities and objectives
• Comprehension: Understands and applies detailed instructions and factual information in oral, written and /or diagram form.
• Initiative / Independence: Works independently with little needed direction taking responsibility for own time and effectiveness. Proactively recognizes opportunities to contribute, recommends and implements process improvements
• Problem Solving: Analyzes data to understand root cause and solves problems with multiple variables, both predictable and unpredictable
• Patient Focus**: Provides care that is respectful of, and responsive to, individual patient preferences, needs and values; listening, informing, and involving patients in their care

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 required
• Master's degree in Medical Bio Technology preferred
• Experience in a clinical or research setting preferred

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