Clinical Research Coordinator, Neurological Surgery

NEUROLOGICAL SURGERY (IN-SNEU-IUINA)

The Indiana University (IU) School of Medicine Department of Neurological Surgery provides world-class clinical care, education, and research in neurosurgery and related neurosciences. Researchers in the Department of Neurological Surgery are passionate about developing innovative techniques and increasing the success of proven treatments to give patients the best chance for healing and recovery. Whether through clinical and laboratory research projects or involvement in multi-center clinical trials and databases, neurological surgery researchers dedicate their life's work to advancing treatment solutions in this critical area of medicine.

Faculty and staff are participating in several nationwide clinical trials.

The Clinical Research Specialist in the Department of Neurological Surgery will work closely with a dynamic and highly engaged clinical research team members and Principal Investigators to conduct Neurosurgery protocols.

• Supports studies in the following specialty areas:
  Neurovascular, Neuro-Oncology, Spine, Functional, Traumatic Brain Injury.
• Performs Institutional Review Board (IRB) and regulatory documentation submission and maintenance.
• Administers informed consent to patients and their Legally Authorized Representatives, data entry, liaison with study sponsors, addressing queries, data entry, Red Cap database development, and conducting study subject visits.

• 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 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.

• 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.

• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.

• 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…