The Indiana University School of Medicine is the largest medical school in the US and is annually ranked among the top medical schools in the US by US News & World Report. For more information, visit our website: here
The primary role of the Clinical Research Coordinator is to initiate and coordinate clinical research studies in Pulmonary Medicine. Assist with protocol development, study feasibility, IRB submissions and maintaining regulatory compliance. Recruit subjects and oversee collection of biological samples and clinical data. Identify problems and develops appropriate solutions. Develop and provide instruction and education to study subjects and families. Evaluate adverse event data and assist with making submission decisions. Primary duties and responsibilities include, but are not limited to:
- Recruit subjects according to IRB-approved protocols. Schedule study visits, complete all necessary pre-visit tasks and execute study procedures according to protocols and clinical needs. Ensure appropriate informed consent processes are followed. Complete all required documentation related to study visits. Coordinate with labs to ensure correct biological samples are collected and processed.
- Collaborate with providers in the collection of clinical data. Extract data from source documents. Create source documentation tools. Complete CRF or database entries. Audit for accuracy. Communicate with research subjects and hospital personnel to obtain follow-up information as needed.
- Participate in developing research protocols including study design and risk to target population. Compose and prepare regulatory/IRB documents for new study submissions, amendments, continuing reviews and close-out. Assess target population/availability. Assist in determining staff, facility and equipment availability.
- Monitor for protocol compliance. Document and report protocol deviations. Capture and record adverse event data and assist the PI in determining submission and reporting of adverse events. Communicate with PI regarding changes in protocols. Maintain documents as required by Regulatory guidelines. Understand and follow IRB guidelines.
- Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
- Train and orient new, less-experienced coordinators. Train support personnel on study-specific tasks.
Bachelor’s degree in science or a health-related field and two years of experience in clinical research; OR Associate’s degree in allied health professions/Bachelor’s degree in other disciplines and three years of experience in clinical research.
Clinical Research Certification (ARCP or SOCRA).
Combinations of education and related experience may by considered.
Knowledge of basic science and clinical research with human subjects. Ability to problem solve with a strong attention to detail. Ability to effectively communicate and exchange information. Strong organizational and project management skills. Possesses a willingness to learn new techniques and skills.
Master’s degree in science or health-related field. Two years of health-related or research experience.
Salary Plan: PAE
Salary Grade: 3RS
Job Function: Research
This posting is scheduled to close at 12:01am EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but it will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
Equal Employment Opportunity
Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University’s Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security