Clinical Research Specialist

Indiana University; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Indiana University in Indianapolis seeks a Clinical Research Specialist to support orthopaedic surgery studies. You will recruit subjects, coordinate visits, manage data, and ensure regulatory compliance per IRB protocols.

You will work with the principal investigator and study team in a fast-paced environment, maintaining high standards of quality, professionalism, and effective communication across all study activities.

Qualifications

• Bachelor's degree in science or health-related field with 1 year health-related or research experience, or an Associate's degree with 3 years of health-related or research experience.
• Proficient communication skills and high professionalism are required.
• Ability to manage time and priorities in a fast-paced environment and maintain quality.

Responsibilities

• Identify and recruit potential study subjects and determine eligibility per IRB/protocols.
• Coordinate study procedures, screenings, consenting, and scheduling of tests and assessments.
• Record data in databases, perform data validation, and generate reports for study stakeholders.
• Monitor adherence to protocol and SOPs, handle regulatory paperwork and communicate changes.
• Assist with budgeting, invoicing for adverse events, and participant billing resolution.
• Provide guidance to less experienced staff when needed.

Skills

Proficient communication

Professionalism

Time management

Quality orientation

Adaptability

Reliability

Initiative

Relationship building

Education

Bachelor's degree in science/health

Associate's degree in allied health

Job description

ORTHOPAEDIC SURGERY (IN-ORTS-IUINA)

The Indiana University (IU) School of Medicine (IUSM) is the largest medical school in the United States and is consistently ranked among the nation's top medical schools by U.S. News & World Report. With more than 60 academic departments and specialty divisions across 9 campuses, as well as strong clinical partnerships with Indiana's leading hospitals and physician networks, IUSM advances its mission to prepare healers and transform health in Indiana and beyond.

The Department of Orthopaedic Surgery is dedicated to providing collaborative, innovative, and comprehensive clinical care, research, and academic training for the next generation of orthopaedic surgeons. Our nationally recognized faculty specialize in a wide range of orthopaedic subspecialties and remain committed to advancing excellence in patient care, education, and research.

The Department of Orthopaedic Surgery at Indiana University School of Medicine (IUSM) is seeking a Clinical Research Specialist to join our team.

General Responsibilities

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experience clinical research staff.

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

Required

• Bachelor's degree in science or a health-related field and 1 year of health-related or research experience; OR
• Associate's degree in an allied health profession and 3 years of health-related or research experience.

Skills

Required

• Proficient communication skills.
• Maintains a high degree of professionalism.
• Demonstrates time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast paced, dynamic environment.
• Highly thorough and dependable.
• Possesses a high degree of initiative.
• Ability to build strong customer relationships.

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.

Indianapolis, Indiana

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.

Career Level: Mastery

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

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

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.

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.

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 [e-mail] or by visiting IUPD.

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