Clinical Research Specialist

ORTHOPAEDIC SURGERY (IN-ORTS-IUINA)

The Indiana University (IU) School of Medicine (IUSM) is the largest medical school in the United States and is consistently ranked among the nation's top medical schools by U.S. News & World Report. With more than 60 academic departments and specialty divisions across 9 campuses, as well as strong clinical partnerships with Indiana's leading hospitals and physician networks, IUSM advances its mission to prepare healers and transform health in Indiana and beyond.

The Department of Orthopaedic Surgery is dedicated to providing collaborative, innovative, and comprehensive clinical care, research, and academic training for the next generation of orthopaedic surgeons. Our nationally recognized faculty specialize in a wide range of orthopaedic subspecialties and remain committed to advancing excellence in patient care, education, and research.

The Department of Orthopaedic Surgery at Indiana University School of Medicine (IUSM) is seeking a Clinical Research Specialist to join our team.

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experience clinical research staff.

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

• Bachelor's degree in science or a health-related field and 1 year of health-related or research experience; OR
• Associate's degree in an allied health profession and 3 years of health-related or research experience.

• Proficient communication skills.
• Maintains a high degree of professionalism.
• Demonstrates time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast paced, dynamic environment.
• Highly thorough and dependable.
• Possesses a high degree of initiative.
• Ability to build strong customer relationships.

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the…