Clinical Research Specialist

Department Information

Department MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for National Institutes of Health (NIH) Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.

The Clinical Research Specialist assists with enrollment of participants into a brain donation program for Parkinson's disease. Clinical sites across the United States refer participants to the program coordinated by Indiana University. The person in this role speaks directly with interested participants and their loved ones about this program and assists in the education, consenting, data collection, donation planning, and coordination of tissue collection for analysis and presentation, including covering a pager with other team members.

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the institutional review board (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…