Clinical Research Coordinator, Neurology
Indiana University, Indianapolis, IN, United States
NEUROLOGY (IN-NEUR-IUINA)
The Indiana University (IU) School of Medicine Department of Neurology has a rich tradition in academic neurology with a national reputation in neurological education and neuroscience research. The department is located in the IU Health Neuroscience Center, a state‑of‑the‑art outpatient center that unites the following specialties that involve nervous system disorders: neurology, neurosurgery, physical medicine and rehabilitation, neuropsychology and neuroradiology. It is also home of the main outpatient neurophysiology laboratory at IU Health. The adjoining IU School of Medicine Neurosciences Research Building enables clinicians, basic scientists, and clinician‑scientists to collaborate in an environment that is rarely achieved in academic medicine.
We are seeking an experienced research staff member to coordinate research trials in our growing neurology department. This is a patient‑facing position that will be tasked with subject recruitment and data management.
General 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 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.
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
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
Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.
Required
Demonstrates analytical skills.
Ability to simultaneously handle multiple priorities.
Possesses strong technical aptitude.
Demonstrates a high commitment to quality.
Excellent organizational skills.
Physical: 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)
Equal Opportunity Employer
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.
#J-18808-Ljbffr
The Indiana University (IU) School of Medicine Department of Neurology has a rich tradition in academic neurology with a national reputation in neurological education and neuroscience research. The department is located in the IU Health Neuroscience Center, a state‑of‑the‑art outpatient center that unites the following specialties that involve nervous system disorders: neurology, neurosurgery, physical medicine and rehabilitation, neuropsychology and neuroradiology. It is also home of the main outpatient neurophysiology laboratory at IU Health. The adjoining IU School of Medicine Neurosciences Research Building enables clinicians, basic scientists, and clinician‑scientists to collaborate in an environment that is rarely achieved in academic medicine.
We are seeking an experienced research staff member to coordinate research trials in our growing neurology department. This is a patient‑facing position that will be tasked with subject recruitment and data management.
General 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 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.
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
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
Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.
Required
Demonstrates analytical skills.
Ability to simultaneously handle multiple priorities.
Possesses strong technical aptitude.
Demonstrates a high commitment to quality.
Excellent organizational skills.
Physical: 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)
Equal Opportunity Employer
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.
#J-18808-Ljbffr