Clinical Research Data Specialist (Clinical Research Specialist)

Indiana University; Indianapolis (IN); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Health insurance

Health Savings Account (HSA)

Flexible spending accounts (FSA)

Life insurance

Retirement plan

Tuition subsidy

Paid holidays

Paid time off

Employee assistance program (EAP)

Job summary

Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office seeks a committed professional to support and facilitate clinical research for adult and pediatric trials. The role includes coordinating visits, ensuring regulatory compliance, and maintaining data integrity across studies.

You will assist with recruitment, scheduling, and communications while staying current on best practices in clinical research.

Qualifications

• Bachelor's degree in science or health-related field with 1 year health-related or research experience.
• Associate's degree in allied health with 3 years health-related or research experience.
• Proficient written and verbal communication skills; professional demeanor.

Responsibilities

• Assist with identifying and recruiting potential research study subjects and determine eligibility per IRB/protocols.
• Coordinate study visits, screenings, consent, scheduling, and follow-up activities for participants.
• Record study data, samples, and results in databases and generate reports for investigators.
• Monitor compliance with SOPs and regulatory paperwork; communicate concerns to the PI.
• Support communications and materials development for recruitment and participant information.
• Stay current on regulatory affairs and best practices through ongoing education and meetings.
• Provide broader project support including budget, invoicing, and patient billing resolution as needed.

Skills

Communication skills

Professionalism

Time management

Quality focus

Flexibility

Dependability

Initiative

Relationship building

Education

Bachelor's degree in science/health

Associate's degree in allied health

Job description

CANCER CENTER (IN-CANC-IUINA)

The mission of the Indiana University (IU) Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication, and long-term follow-up.

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the Institutional Review Board (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.

Required

EDUCATION / WORK EXPERIENCE

• 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 written and verbal 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.

IUSCCC Clinical Trials Office

IU Indianapolis Campus

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)

Career Level: Mastery

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

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.

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.