Clinical Research Coordinator, Pediatric Hematology/Oncology

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of Indiana University (IU) School of Medicine (IUSM) 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.


Job Summary


Department-Specific Responsibilities

• Determines and verifies patient eligibility per study requirements and ensures consents are obtained for the clinical trial.
• Collects and evaluates the study data and submits data reports to sponsors/principal investigators (PI).
• Ensures compliance with study schedules and data submission.
• Coordinates and ensures collection and processing of specimens as directed by the clinical trial.
• Coordinates site visits and monitoring visits with sponsors.
• Works with financial staff to determine study versus standard of care procedures for study billing compliance.
• Prepares and documents protocol deviations as required by sponsor and institutional review board (IRB). Prepares study documents, sponsor or regulatory agency audits, or monitoring visits.

General 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 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 1 year of clinical research experience; OR
• Associate's degree in science or a health-related field and 2 years of clinical research experience.

LICENSES AND CERTIFICATES

Preferred

• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.

SKILLS

Required

• Demonstrates 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.


Additional Information


This position is not eligible for visa sponsorship.


Work Location


Indianapolis, Indiana


Advertised Salary


$50,000.00 - 60,000.00 annually based on a combination of experience, skill level, education, and training.


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 & 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: Core

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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


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 .


Campus Safety and Security


The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at View email address on click.appcast.io or by visiting IUPD.


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