Indiana University
Clinical Research Coordinator (Clinical Research Patient Specialist)
Indiana University, Indianapolis, Indiana, us, 46262
The mission of the IU Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long‑term follow‑up. As the state's premier urban research institution, IU Indianapolis is committed to being a welcoming campus community and we seek candidates whose research, teaching, and community engagement efforts contribute to robust learning and working environments for all students, staff, and faculty.
Job Summary
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 IUSCCC Clinical Trials Office Indianapolis Campus Indianapolis, Indiana
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: Career 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 iups@iu.edu or by visiting IUPD.
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Job Summary
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 IUSCCC Clinical Trials Office Indianapolis Campus Indianapolis, Indiana
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: Career 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 iups@iu.edu or by visiting IUPD.
#J-18808-Ljbffr