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. Researchers in the Division of Pulmonary Medicine at the IU School of Medicine pursue a variety of basic, translational and clinical research projects in the fields of pulmonary and critical care medicine. Studies are conducted in facilities located on the school's Indianapolis campus, its affiliated hospitals and in collaboration with investigators in other IU School of Medicine divisions and centers and at other academic institutions. Division research is funded by the National Institutes of Health, the Department of Veterans Affairs, non-profit organizations, foundations and industry.
The person in this role will be the primary research coordinator across a range of studies in pulmonary and sleep medicine. The potential areas of research may include sleep apnea, asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, or pulmonary hypertension. The research coordinator will be working independently on all aspects of clinical research and will be supported by an experienced clinical research team.
Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
Participates in study budget negotiations and reconciles study budget accounts.
Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
Stays up to date with knowledge of regulatory affairs and/or issues.
Note: This position may be eligible for a sign-on bonus.
EDUCATION / WORK EXPERIENCE
Bachelor's degree in science or a health-related field and 2 years of clinical research experience OR
Associate degree in science or a health-related field and 3 years of clinical research experience
Combinations of related education and experience may be considered
LICENSES AND CERTIFICATES
SOCRA/ARCP Clinical Research Certification upon date of hire
Demonstrated analytical skills
Ability to simultaneously handle multiple priorities
Possesses strong technical aptitude
Demonstrates a high commitment to quality
Excellent organizational skills
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Career Level: Career
Job Function: Research
Job Family: Clinical Research
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Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
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