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. Please visit our website here for additional information about the Department of Medicine.
The Division of Cardiology at IUSM has multiple research laboratories conducting studies in various aspects of cardiovascular diseases, including but not limited to electrophysiology, genetics and pulmonary hypertension. The Krannert Institute of Cardiology Clinical Trial Office participates in multiple clinical studies related to clinical cardiology. There are ACGME approved cardiology training programs in cardiovascular diseases, cardiovascular electrophysiology, interventional cardiology and heart failure.
We are searching for a Clinical Research Specialist to join our unique research team. We are seeking individuals who thrive in a fast-paced working environment. Clinical Research Specialists are communicative and proactive in the support and implementation of the clinical research studies. They will build long-lasting, mutually beneficial relationships with their patients and research staff alike. Specialists are continually striving to find the best strategies for the Division's studies.
Job Duties and Responsibilities:
- Assist in the conduct and implementation of clinical research/trials in the Division of Cardiology. Participate in the initiation, monitoring, completion, and reporting of routine to moderately complex clinical studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP).
- Participate in the evaluation of the protocol, study design and risk to subject population. Access and extract information for protocol development for medical library and online databases.
- Participate in protocol development or review of risk assessment for investigator-initiated trial. Assist in determination of staff availability and assessment of study population/availability.
- Participate in the preparation and negotiation of study budget. Determine facility/equipment availability. Participate in critical evaluation and make comment on contracts/agreement.
- Compose and supervise preparation of regulatory documents including updates to Informed Consent forms.
- Assist in developing advertisement and other information materials for recruitment. Identify and schedule screening procedures and review results.
- Contact outside health care providers to obtain follow up information. Communicate with subjects to obtain follow-up information.
- Assist in developing and implementing teaching tools for subjects and families. Train support personnel on study specific tasks. Serve as an advocate for the subjects and their family.
- Lead Retrospective and Observational trials. Recruit subjects according to IRB/protocol approved methodologies. Consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study.
- Determine appointments per protocol. Schedule and/or call subjects for appointments. Coordinate subject visits with support services.
- Extract data from source documents. Compete Case Report Forms (CRF) or database entries.
- Oversee the proper handling of laboratory specimens including processes, shipping, storage, and documentation.
- Review incoming subject adverse event (SAE) information and assist PI in making submission and/determination of SAEs.
- Capture and record adverse events data. Compose adverse event reports for oversight agencies. Compose and submit continuing review/amendments/close out information.
- Assist in the preparation for monitoring visits.
- Monitor and ensure study team compliance with protocol and SOPs. Record, document and report protocol deviations. Communicate with PI and sub-investigators about changes in the trial.
- 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 meeting.
- Perform other related duties incidental to the work described herein.
Bachelor's degree in science or a health-related field and one year of health-related/research experience; OR any bachelor's degree/associate's degree in Allied Health professions and three years of health-related/research experience or two years of experience in clinical research.
Ability to effectively communicate and exchange information with a wide variety of individuals. Excellent interpersonal skills and customer service orientation. Strong organizational and multitasking skills, including the ability to manage multiple priorities.
SOCRA or ACRP certification. Some experience in cardiology.
Salary Plan: PAO
Salary Grade: 2RS
Job Function: Research
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.
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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.