Clinical Research Coordinator

Indiana University Northwest; Indianapolis (IN); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading university in Indianapolis seeks a Clinical Research Coordinator to oversee clinical research studies. The role involves protocol evaluations, budget negotiations, and ensuring compliance with regulatory standards. Candidates should possess a relevant degree and have experience in clinical research. Comprehensive benefits are offered, including medical insurance and tuition subsidies.

Benefits

Medical and Dental Insurance

Health Savings Accounts

Flexible Spending Accounts

Life Insurance

Retirement Plans

Tuition Subsidies

Paid Holidays and Time Off

Parental Leave

Qualifications

• 2 years of clinical research experience required with Bachelor's degree.
• 3 years of clinical research experience required with Associate's degree.

Responsibilities

• Conducts protocol review and evaluations for clinical research studies.
• Monitors enrollment goals and modifies recruitment strategies as needed.
• Ensures compliance with regulations and prepares IRB documents.

Skills

Analytical Skills

Organizational Skills

Technical Aptitude

Education

Bachelor's degree in science or health-related field

Associate's degree in science or health-related field

Job description

The study of emergency medicine is a broad field that covers the variety of ailments arriving at the emergency room, with a deep focus on how to improve particular aspects of urgent care. Throughout their clinical research initiatives, faculty members of Indiana University School of Medicine's Department of Emergency Medicine are devoted to developing future leaders and investigators, dedicating funds and considerable resources to continue their successful track record of mentorship.

Job Summary

1. Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
2. Participates in study budget negotiations and reconciles study budget accounts.
3. Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
4. Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (e.g., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
5. 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).
6. Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)
7. Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
8. Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
9. Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
10. 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 2 years of clinical research experience; OR Associate's degree in science or a health-related field and 3 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 handle multiple priorities, strong technical aptitude, high commitment to quality, excellent organizational skills.

Working Conditions / Demands

The role requires effective communication, ability to move about the environment, operate laboratory equipment, move objects up to 25 pounds, and occasionally work near moving mechanical parts. The person must perform essential functions with or without accommodations.

Work Location

Indianapolis, Indiana

Benefits Overview

Indiana University offers comprehensive benefits including medical and dental insurance, health savings accounts, flexible spending accounts, life insurance, retirement plans, tuition subsidies, paid holidays and time off, and parental leave.

This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. The posting may close earlier at the discretion of the University but will remain open for a minimum of 5 business days. To ensure full consideration, submit your application within 5 business days of the Posted Date.

If desired, include a cover letter with your resume when uploading attachments.

The Annual Security and Fire Safety Report, containing policy statements, crime, and fire statistics for all Indiana University campuses, is available online. Requests for a physical copy can be made by emailing IU Public Safety at [e-mail] or visiting IUPD.