Indiana University Purdue University Indianapolis Looking for Clinical Research Coordinator, Pediatric Infectious Disease Research Full Time

Job ID: 307790

Department

PED-INFECTIOUS DISEASE RESEARC (IN-PIFB-IUINA)

Department Information

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 U.S. News and World Report.

The Ryan White Center for Pediatric Infectious Diseases and Global Health in the Department of Pediatrics at the Indiana University School of Medicine is a national leader in global pediatric infectious disease clinical care, research, and education. With 24 plus clinical and research faculty and a dedicated team of clinical and research staff, the division’s focus on global child health reflects the understanding that infectious diseases know no boundaries. We take seriously our mission to improve child health in Indiana and around the world!

Job Summary

This is a unique opportunity to be involved in research studies that have the potential to transform child health globally and improve the health and lives of underserved children in low-income countries, through study design, performance, regulatory and monitoring work that insures that these studies are of the highest quality.

Department-Specific Responsibilities

• Provides operational management and oversite of pediatric infectious diseases & global health clinical research under the direction of the principal investigator and academic administrator in accordance with good clinical practice and institutional standard operating procedure.
• Identifies issues and/or areas of improvement and implements solutions to improve processes and/or research outcomes.
• Manages routine to moderately complex clinical studies being facilitated in partnership with our international collaborators (Uganda, Kenya, etc.) within our Global Health footprint, and ensures quality assurance, database maintenance, proper documentation and reporting, and compliance with various policies and regulations.
• Serves as a key liaison between the research staff and division leadership, faculty, collaborators and international groups and may also assist fiscal team with budgetary and fiscal management.

General Responsibilities

• 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.

Qualifications

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’s degree in science or a health-related field and 3 years of clinical research experience.

LICENSES AND CERTIFICATES

Preferred

• SOCRA/ARCP Clinical Research Certification upon date of hire.

SKILLS

Required

• 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.

Work Location

Indianapolis, Indiana

Advertised Salary

$55,000 – $65,000 per year based on experience, skill level, education, and training.

Benefits Overview

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.

Job Classification

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

Click here to learn more about Indiana University’s Job Framework.

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.

Contact Us

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Telephone: 812-856-1234