PED-ENDOCRINOLOGY/DIABETOLOGY (IN-PEND-IUINA)

For more than 90 years, the Department of Pediatrics at Indiana University School of Medicine has provided comprehensive medical training for medical students, residents and fellows in addition to lifelong learning opportunities for practicing physicians. The department consists of 19 specialty divisions based at Riley Hospital for Children at Indiana University Health, which is ranked as one of America's Best Children's Hospitals in 10 out of 10 specialties in US News and World Report.

The Division of Pediatric Endocrinology and Diabetology in the Department of Pediatrics at IU School of Medicine promotes the health of children with endocrine disorders, advances knowledge through research and other scholarly activities, and provides high-quality clinical services, child advocacy and medical education. The division is dedicated to biomedical education through instruction of medical, graduate and post-doctoral level students as well as residents and fellows.

The Division of Pediatric Endocrinology/Diabetology is seeking a part-time Clinical Research Coordinator. This position will assist in the conduct and implementation of clinical research in Pediatric Endocrinology including endocrine and diabetes related studies.

Department-Specific Responsibilities

• Initiates, conducts, monitors, and coordinates clinical studies or trials in accordance with protocols, regulatory and standard operating procedures (SOP), and Good Clinical Practice (GCP) compliance.
• Assists Principal Investigator (PI) and participates in protocol development, evaluation, and review of risk assessment; evaluates study design and risk to subject population; determines staff, facility, and equipment availability; assesses study population and availability.

• Composes and submits continuing review, amendments, and close out information; schedules and prepares for monitor visits; prepares and responds to Sponsor and/or FDA audits.

• Designs recruitment strategies for each assigned study; recruits subjects according to IRB/protocol approved methodologies; consents subjects, including discussion of treatment and intervention alternatives; monitors enrollment goals and modifies recruitment strategy as needed.

• Liaisons with healthcare professionals and providers to determine best recruitment practices for study; manages subject recruitment including marketing, screening procedures, and enrollment.

• Ensures proper collection, processing, shipment of specimens, and documentation; communicates with laboratory, PI, and sponsor regarding laboratory findings; records and documents protocol deviations; communicates with PI and sub-investigators about changes in the trial.

• Participates in preparation and negotiation of study budget and reconciles study budget accounts.

• Reviews, critically evaluates, and comments upon study contracts/agreements.

• Prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary).

• Schedules study-related meetings and training sessions and provides instruction to study team for specific study assignments; educates staff regarding scientific aspects of study and trains ancillary staff regarding clinical studies or trials; monitors study team compliance with required study procedures and GCP standards.

• Manages research study inventory and supplies (such as medications, equipment, devices) and maintains required compliance documentation.

• Stays up-to-date and maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION / WORK EXPERIENCE

Required

• 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.

LICENSES AND CERTIFICATES

Preferred

• SOCRA/ARCP Clinical Research Certification.

SKILLS

Required

• Demonstrated analytical skills.

• Ability to simultaneously handle multiple priorities.

• Possesses strong technical aptitude.

• Demonstrates a high commitment to quality.

• Excellent organizational skills.

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

Indianapolis, Indiana

20 - 25 hours per week.

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

• Multiple plan options for medical insurance
• Dental insurance
• Health Savings Account with generous IU contribution
• Life insurance, LTD, and AD&D options
• Base retirement plan contribution from IU, subject to vesting
• Additional supplemental retirement plan options
• Tuition benefit for IU classes
• 10 paid holidays per year
• Generous Paid Time Off
• Paid Parental Leave
• Employee Assistance Program (EAP)

Learn more about our benefits by reviewing our online Benefits Brochure.

Career Level: Part Time Employee

FLSA: Nonexempt

Job Function: Part Time Employee

Job Family: Part Time Employee

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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.

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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