Job ID: 320666
DepartmentMMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
Department InformationOne of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for National Institutes of Health (NIH) Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the…
integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
Job SummaryThis position serves as the lead coordinator for IU Digital Core supporting the Michael J. Fox Foundation's Platform Trial Program (P2P), a multi-site master protocol evaluating multiple investigational therapies for Parkinson's disease.
Department-Specific Responsibilities
- Oversees the complete lifecycle of device management-inventory control, device activation and assignment, shipment to study sites, participant support, device return, data transfer, quality assurance, and regulatory compliance
- Programs and assigns wearable devices for scheduled study visits, maintains device accountability logs, ensures accurate documentation, monitors inventory, and ensures timely receipt and redistribution of devices. Manages secure transfer of digital data and verifies quality in accordance with the protocol.
- Coordinates all operational activities related to the digital biomarker component of the study across participating United States (US) and outside of United States (OUS) sites
- Leads Digital Core operations, manages digital device lifecycle and inventory, coordinates digital data management and quality assurance, regulatory compliance and technical support, training, process improvement, and documentation
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 Principal Investigator (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
Required
- 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
Preferred
- 3 years of clinical research experience
- IRB submission 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
Preferred
- Experience with REDCap database
- Independent prioritization skills and technical aptitude
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.
Additional InformationThis position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
This position is not eligible for visa sponsorship.
Work LocationIU Indianapolis
This position is eligible for a hybrid schedule (mix between remote and 3-5 days in-person work), subject to change in the future based on university policy and business needs.
Advertised Salary$50,000.00 - 60,000.00 per year based on experience and internal equity within the department.
Benefits OverviewFor 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.
Job ClassificationCareer Level: Core
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
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Equal Employment OpportunityIndiana 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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Telephone: 812-856-1234