EMERGENCY MEDICINE (IN-EMER-IUINA)
The Indiana University School of Medicine Department of Emergency Medicine is a statewide network of emergency departments striving to set new standards of training for medical students, residents, fellows and pre-hospital providers while providing quality care for a diverse patient population.
IU School of Medicine leads in the science of emergency medicine, operating in an environment that has rich research infrastructure, including the highest-ranked Clinical and Translational Science Institute (CTSI) in the United States and a nationally ranked medical bio-informatics institution. Multiple clinical environments present practitioners with ample opportunity to make a difference in the lives of patients on a daily basis.
- Assists in the conduct of clinical trials and research involving human subjects.
- Performs varied routine and non-routine tasks of moderate to significant complexity.
- Initiates, conducts, completes and reports multiple clinical studies simultaneously, that run the gamut from convenience sample surveys to biomarker studies to Phase III, global, multi-center interventional clinical trials involving novel therapeutics and devices.
- Develops solutions to complex problems that impact the timeliness and accuracy of the conduct of our clinical research.
- Functions as an extension of the PI for clinical research related activities.
- Identifies potential subjects from review of existing protected health information based on inclusion/exclusion criteria.
- Identifies, schedules screening procedures and reviews results; recruits subjects and keeps accurate records.
- Obtains patient consent including discussion of treatment/intervention alternatives and signature on Informed Consent forms.
- Determines appointments with study subjects, families, and medical staff per protocol; serves as an advocate for the subjects and their family; prepares for monitor visits; records, documents and reports protocol deviations.
- Facilitates and participates in pre-study visits with sponsor.
- Extracts data from source documents and completes Case Report Forms (CRF) or database entries on various platforms (experience with industry eCRFs as well as REDCap is a plus).
- Orders and receives drug/device supplies as directed.
- Captures and records adverse event data.
- Manages handling and processing of laboratory specimens; maintains sample/specimen tracking and inventory.
- Prepares and presents study protocol reviews at monthly meetings; reviews ongoing study subjects on a daily basis.
- Aids with administrative duties for the clinical program, including but not limited to, entering study data into study databases, filing, photocopying, preparing study folders for multiple studies, arranging meetings, and data entry.
- Participates in protocol review (evaluations, study design and risk assessments to subject population).
- Prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, Amendments, Continuing Reviews, and study close out).
- Develops informational materials for recruitment; organizes and distributes regulatory documents; assesses study population/availability; provides/secures source documentation tools for subjects' charts/records.
- May assist and work with research staff and assistants, residents, students, and volunteers. Takes call when needed as a shared responsibility within the team.
EDUCATION / WORK EXPERIENCE
- Bachelor's degree from an accredited institution in science or health related field; OR
- Bachelor's degree in other research experience; OR
- Associate degree from accredited institution in allied health profession and 1 year of patient-related or research experience; OR
- High school diploma or GED and 5 years of patient-related experience with 2 years in clinical study.
- Knowledge of Standard Operating Procedures, International Conference on Harmonization Good Clinical Practices, and Federal Regulations.
- Understanding of clinical research studies within an inpatient and outpatient setting.
- Ability to organize and prioritize responsibilities.
- Strong interpersonal skills and willingness to develop relationships with the patients and families participating in the research trials.
- Ability to understand study protocols, study design, and procedures and then assist in translating them into IRB submissions.
- Ability to evaluate the protocol, study design and risk to subject population.
- Ability to prioritize multiple studies and work effectively with the PI.
- Ability to work in a cooperative setting to initiate studies at the site and develop the tools necessary to assist health care personnel carry out the trial in an effective and efficient manner.
- Ability to effectively communicate and exchange information.
- Ability to work in a team environment with a professional and positive attitude and be capable of communication/interaction with the public, patients and medical staff.
IU Health Methodist Hospital
Career Level: Temporary
Job Function: Temporary Hourly
Job Family: Temporary Regular
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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.
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but 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.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.
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 based on individual qualifications. Indiana University prohibits discrimination based on 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.
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