Description

In Vitro Diagnostics Development and Clinical Trials Group offers integrated services for every stage of clinical research from development to commercialization. A results-driven academic enterprise, this group provides professional clinical laboratory medicine expertise for the laboratory diagnostics industry. The group's clinical footprint and centralized laboratories affords near limitless resources for the evaluation of developing clinical laboratory technologies.
The In Vitro Diagnostics Development and Clinical Trials Group team evaluates new In Vitro Diagnostic (IVD) devices or assays by comparison to conventional laboratory testing and/or similar molecular or analytic tests. Available services include reproducibility/precision testing, access to banks of clinical samples/tissue/microorganisms for the evaluation of new technologies, assays, antimicrobials, and detection/identification systems. The research team is comprised of personnel that are certified Medical Technologists as well as Certified Clinical Research Coordinators by ACRP/SOCRA with many years of experience in all phases and processes for conducting clinical research (GCPs, IRB submissions, contract negotiations).
The In Vitro Diagnostics Development and Clinical Trials Group is actively involved with numerous corporations/investigators in the development of new technologies (alpha, beta, pre-clinical & investigator-initiated studies), collaborating with industrial and academic organizations on any phase of the developmental research and clinical trial process, including expert review of biopsy histopathology or cytology.

Job Summary

Department-Specific Responsibilities

• Specializes in IRB, contracting and invoicing.
• Responsible for managing the administrative and regulatory aspects of clinical research studies.
• Ensures compliance with Institutional review board guidelines.
• Coordinates contractual agreements with study sponsor.
• Actively participates in overseeing participant recruitment, data collection and study execution.
• Oversees the maintenance and adherence of the Clinical research team to Good Clinical Practices and standards.
• Conducts routine experiments and/or coordinates research study procedures in accordance with SOPs; receives, collects, and records study data in database; communicates and keeps researchers and/or PI up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures.
• Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families.
• Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits.

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 plus 1 year of clinical research experience; OR
• Associate's degree in science or a health-related field plus 2 years of clinical research experience

Preferred

• Phlebotomy 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

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

Indianapolis, Indiana

Benefits Overview

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 .

Job Classification

Career Level: Core
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
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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 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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