Clinical Research Coordinator, Neurology

Indiana University; Indianapolis (IN); Sur place; USD 52 000 - 76 000; Plein temps

Avantages offerts par ce poste

Comprehensive medical and dental_ins

Health savings account with generousIU

Tuition subsidy for employees and/or家

10 paid holidays + winter break

Generous paid time off

Employee assistance program (EAP)

Résumé du poste

Indiana University in Indiana is seeking a Clinical Research professional for the Neurology department. The role focuses on protocol design, regulatory compliance, and subject recruitment within a busy academic research setting.

Responsibilities include budgeting, IRB submissions, subject screening, data collection, and coordination with healthcare teams. Strong organizational skills and attention to quality are essential for success.

Qualifications

• Bachelor's degree plus 1 year clinical research experience, OR Associate's degree plus 3 years clinical research experience.
• SOCRA/ACRP certification preferred at date of hire.

Responsabilités

• Initiates and conducts protocol review, evaluations, study design, and risk assessments.
• Participates in study budget negotiations and reconciles budget accounts.
• Develops recruitment materials and monitors enrollment goals.
• Ensures regulatory compliance and submits IRB documents and regulatory paperwork.
• Identifies and screens potential subjects and conducts interviews.
• Follows up with stakeholders and manages study documentation.
• Reviews SAE information and assists PI with submission determinations.
• Performs non-medical/behavioral assessments and required procedures.
• Records protocol deviations and stays current with regulatory affairs.

Connaissances

Analytical skills

Multitasking

Technical aptitude

Quality focus

Organizational skills

Formation

Bachelor's degree in science or health-related field

Associate's degree in science or health-related field

Description du poste

NEUROLOGY (IN-NEUR-IUINA)

The Indiana University (IU) School of Medicine (IUSM) 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 all the 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 IUSM Neurosciences Research Building enables clinicians, basic scientists and clinician‑scientists to collaborate in an environment that is rarely achieved in academic medicine.

• 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 EXPEREINCE

Required

• Bachelor's degree in science or a health‑related field and 1 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.

Skills

Required

• Demonstrates 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.

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.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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.

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