Clinical Research Specialist, Developmental Pediatrics

PED-DEVELOPMENTAL MEDICINE (IN-PDVL-IUINA)

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of IU School of Medicine to make Riley Children's Health Indiana's largest and most skilled pediatric system. At IUSM, our mission and core values define who we are, how we act, and what we aspire to accomplish. If you choose to join our team, you can expect a culture that values excellence, respect, integrity, diversity, and cooperation.

The Developmental Pediatrics Division has grown the number of faculty interested in research and in need of support for their research initiatives. They are seeking a Clinical Research Specialist to assist in enrollment and recruitment of participants, management of screening and data collection, and submitting IRB protocol and review documents.

Department-Specific Responsibilities

• Verifies participant eligibility, recruitment and enrollment of eligible participants, conducting the informed consent and assent process, management of screening and enrollment log, data collection from participants at visits, extraction of data from electronic health records, and data entry into registry database.
• Manages and organizes of physical documents from psychology faculty appointments (e.g., test protocols). This task currently includes gathering labels, creating folders, identifying measures completed, filing documents, saving/transferring data to the data archive system, and locating missing protocols.
• Enters patients into the database, transferring in-clinic consent documents to the database, data cleaning, and auditing user access to the database (e.g., ensuring that previous employees no longer have data access).
  
  

General Responsibilities

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects; coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and SOPs; submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experience clinical research staff.
  
  

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.

Required

EDUCATION/WORK EXPERIENCE

• Bachelor's degree in science or a health-related field and 1 year of health-related or research experience OR
• Associate's degree in an allied health profession and 3 years of health-related or research experience
  
  

Skills

Required

• Proficient communication skills
• Maintains a high degree of professionalism
• Demonstrates time management and priority setting skills
• Demonstrates a high commitment to quality
• Possesses flexibility to work in a fast paced, dynamic environment
• Highly thorough and dependable
• Possesses a high degree of initiative
• Ability to build strong customer relationships
  
  

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.

Indianapolis, Indiana

The annual salary range for this position is $45,000 - $50,000. Salary determination is based on a combination of experience, skill level, education, and training.

This position is not eligible for visa sponsorship.

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 & 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.

Career Level: Mastery

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

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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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