Part-Time Clinical Research Coordinator

Department

CARDIOVASCULAR MEDICINE (IN-CARD-IUINA)

Department Information

The Division of Cardiovascular Medicine in the Department of Medicine has multiple research laboratories conducting studies in various aspects of cardiovascular diseases, including but not limited to electrophysiology, genetics, and pulmonary hypertension. The Krannert Cardiovascular Research Center's (KCVRC) Clinical Trial Office participates in multiple clinical studies related to clinical cardiology. There are Accreditation Council for Graduate Medical Education (ACGME) approved cardiology training programs in cardiovascular diseases, cardiovascular electrophysiology, interventional cardiology, heart failure, and adult congenital heart disease.

The KCVRC has, as its charge, the interdisciplinary advancement in understanding, preventing, and treating cardiovascular diseases, translating basic discoveries to favorably impact the cardiovascular health of the people of Indiana and beyond. The Center aims to advance the capabilities of high impact programmatic teams and a pipeline of talent to establish around strong pillars and cross-cutting themes in cardiovascular science.

Job Summary

Department-Specific Responsibilities

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies
• Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
• Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects
• Facilitates and performs various study activities including site evaluation visits, study related meetings and training sessions, study initiation visits (SIV) and monitoring visits
• Manages all follow-up activities with subjects based on protocols and oversees proper documentation at study close-out
• 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
• 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

Qualifications

EDUCATION

Required

• High school diploma or equivalent (such as HSED or GED)

SKILLS

Required

• Proficient communication skills

Working Conditions / Demands

The person in this role must be able to perform the essential functions with or without accommodation.

Work Location

Methodist Hospital

Indianapolis, Indiana

This position is eligible for a hybrid schedule (mix between remote work and 3 days of in-person work), subject to change in the future based on university policy and business needs.

Work Hours

Maximum of 29 hours per week

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure.

Job Classification

Career Level: Part Time Employee

FLSA: Nonexempt

Job Function: Part Time Employee

Job Family: Part Time Employee

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Posting Disclaimer

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.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.

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Contact Us

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Telephone: 812-856-1234