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Regulatory Coordinator,

2 months ago

Indianapolis, United States Indiana University Full time
Department

NEUROLOGY (IN–NEUR–IUINA)

Department Information

The Indiana University School of Medicine Department of Neurology, under the leadership of Professor and Chair Laurie Gutmann, MD, has a rich tradition in academic neurology with a national reputation in neurological education and neuroscience research. The department is located in the Indiana University Health Neuroscience Center, a state–of–the–art outpatient center that unites all the specialties that involve nervous system disorders; Neurology, Neurosurgery, Psychiatry, 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.

Job Summary

The Neurology Clinical Trials team is seeking a Regulatory Coordinator. This role is not patient facing.

Department–Specific Responsibilities
Performs regulatory document completion, maintenance, and oversight. General 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 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

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

Required
Bachelor's degree in science or a health–related field and 1 year of clinical research experience; ORAssociate's degree in science or a health–related field and 2 years of clinical research experience. LICENSES AND CERTIFICATES

Preferred
SOCRA/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.Preferred
Strong attention to detail. Excellent time management skills.
Working Conditions / Demands

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.

Work Location

This position is eligible to work a hybrid schedule (mix between 2 days remote and 3 days in–person work), subject to change in the future based on university policy and business needs.

Benefits Overview

For full–time staff employees, Indiana University offers a wide array of benefits including:
Multiple plan options for medical insuranceDental insuranceHealth Savings Account with generous IU contributionLife insurance, LTD, and AD&D optionsBase retirement plan contribution from IU, subject to vestingAdditional supplemental retirement plan optionsTuition benefit for IU classes10 paid holidays per yearGenerous Paid Time OffPaid Parental LeaveEmployee Assistance Program (EAP)Learn more about our benefits by reviewing our online Benefits Brochure.

Job Classification

Career Level: Core

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

This 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.

Equal Employment Opportunity

Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non–Discrimination here which includes contact information.

Campus Safety and Security

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 or by visiting IUPD.

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