Clinical Research Coordinator

Company: Indiana University
Location: Indianapolis
Posted on: October 13, 2024

Job Description:

DepartmentHEREDITARY GENOMICS DIVISION (IN-HGN-IUINA)Department InformationOne of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at 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 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 Summary

• 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.QualificationsCombinations 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 EXPERIENCERequired
  • 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 experienceLICENSES AND CERTIFICATESPreferred
    • SOCRA/ARCP Clinical Research Certification upon date of hireSKILLSRequired
      • Demonstrated analytical skills
      • Ability to simultaneously handle multiple priorities
      • Possesses strong technical aptitude
      • Demonstrates a high commitment to quality
      • Excellent organizational skillsWorking Conditions / DemandsThe 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 LocationIU IndianapolisThis position is eligible for remote work or in-person work. However, this is subject to change in the future based on university policy and business needs.Advertised Salary$49,505.00 - $59,505.00 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:
        • Multiple plan options for medical insurance
        • Dental insurance
        • Health Savings Account with generous IU contribution
        • Life insurance, LTD, and AD&D options
        • Base retirement plan contribution from IU, subject to vesting
        • Additional supplemental retirement plan options
        • Tuition benefit for IU classes
        • 10 paid holidays per year
        • Generous Paid Time Off
        • Paid Parental Leave
        • Employee Assistance Program (EAP)Learn more about our benefits by reviewing our online Benefits Brochure.Job ClassificationCareer Level: CoreFLSA: ExemptJob Function: ResearchJob Family: Clinical Research Click here to learn more about Indiana University's Job Framework.Posting DisclaimerThis 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 OpportunityIndiana 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 SecurityThe 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 iups@iu.edu or by visiting IUPD.Contact UsRequest SupportTelephone: 812-856-1234

Keywords: Indiana University, Fishers , Clinical Research Coordinator, Healthcare , Indianapolis, Indiana