Indiana University
Clinical Research Coordinator (Clinical Research Patient Specialist)
Indiana University, Indianapolis, Indiana, us, 46262
Clinical Research Coordinator (Clinical Research Patient Specialist)
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Clinical Research Coordinator (Clinical Research Patient Specialist)
role at
Indiana University
CANCER CENTER (IN-CANC-IUINA) 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.
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 Required
Education: 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.
Preferred
SOCRA/ARCP Clinical Research Certification upon date of hire.
Skills
Demonstrated analytical skills.
Ability to simultaneously handle multiple priorities.
Possesses strong technical aptitude.
Demonstrates a high commitment to quality.
Excellent organizational skills.
The role regularly requires the ability to effectively communicate and move objects weighing up to 25 pounds. The person in this role must be able to perform the essential functions with or without an accommodation.
Benefits
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).
Indiana University is an equal‑opportunity employer and provider of ADA services and prohibits discrimination in hiring.
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Clinical Research Coordinator (Clinical Research Patient Specialist)
role at
Indiana University
CANCER CENTER (IN-CANC-IUINA) 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.
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 Required
Education: 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.
Preferred
SOCRA/ARCP Clinical Research Certification upon date of hire.
Skills
Demonstrated analytical skills.
Ability to simultaneously handle multiple priorities.
Possesses strong technical aptitude.
Demonstrates a high commitment to quality.
Excellent organizational skills.
The role regularly requires the ability to effectively communicate and move objects weighing up to 25 pounds. The person in this role must be able to perform the essential functions with or without an accommodation.
Benefits
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).
Indiana University is an equal‑opportunity employer and provider of ADA services and prohibits discrimination in hiring.
#J-18808-Ljbffr