Indiana University
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Clinical Research Coordinator
role at
Indiana University
PSYCHIATRY (IN-PSYC-IUINA)
The Department of Psychiatry at Indiana University (IU) School of Medicine is committed to understanding the symptoms and neurobiological basis of mental illness and advancing psychiatric treatments through extensive involvement in basic and clinical research and patient care. The department is also involved with educating and training future leaders of psychiatry and behavioral science.
IU School of Medicine is closely aligned with our health system partner, IU Health, which has twice earned a place on the United States (US) News and World Report Honor Roll. The shared vision of both institutions is to lead the transformation of healthcare through quality innovation and education to make Indiana one of the nation's healthiest states. IU Health is among the top 10 largest single‑state nonprofit health systems in the United States operating 16 hospitals statewide (a mix of urban, suburban and rural facilities). This partnership enables the seamless integration of research findings into patient care.
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 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 Principal Investigator (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.
Education and Work Experience
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 (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.
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.
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)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Career Level Core
FLSA Exempt
Job Function Research
Job Family Clinical Research
Seniority level Not Applicable
Employment type Full‑time
Job function Research, Analyst, and Information Technology
Industries Higher Education
The 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 opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non‑Discrimination here which includes contact information.
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.
Request Support: Telephone: 812-856-1234
#J-18808-Ljbffr
Clinical Research Coordinator
role at
Indiana University
PSYCHIATRY (IN-PSYC-IUINA)
The Department of Psychiatry at Indiana University (IU) School of Medicine is committed to understanding the symptoms and neurobiological basis of mental illness and advancing psychiatric treatments through extensive involvement in basic and clinical research and patient care. The department is also involved with educating and training future leaders of psychiatry and behavioral science.
IU School of Medicine is closely aligned with our health system partner, IU Health, which has twice earned a place on the United States (US) News and World Report Honor Roll. The shared vision of both institutions is to lead the transformation of healthcare through quality innovation and education to make Indiana one of the nation's healthiest states. IU Health is among the top 10 largest single‑state nonprofit health systems in the United States operating 16 hospitals statewide (a mix of urban, suburban and rural facilities). This partnership enables the seamless integration of research findings into patient care.
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 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 Principal Investigator (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.
Education and Work Experience
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 (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.
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.
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)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Career Level Core
FLSA Exempt
Job Function Research
Job Family Clinical Research
Seniority level Not Applicable
Employment type Full‑time
Job function Research, Analyst, and Information Technology
Industries Higher Education
The 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 opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non‑Discrimination here which includes contact information.
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.
Request Support: Telephone: 812-856-1234
#J-18808-Ljbffr