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:
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).
Combination 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 as needed.
Master's degree in science or health-related field and two years of health-related or research experience.
Salary Plan: PAE
Salary Grade: 3RS
Campus: IUPUI - Indianapolis
Department: PULMONARY (IN-PULM-IUINA)
Internal Number: 77999
About Indiana University
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.