Attends weekly team meetings and Operations meetings to relay the progress of studies and collections to the team.
Assists with invoicing, contracting, and IRB submissions as needed.
Assists with maintenance of the Regulatory Binders and filing of research documents.
Assists with making collection packets for different studies and control of gift cards and logs for tracking the cards.
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 PI, sub-investigators, and/or other study stakeholders.
Monitors study team compliance with protocol and 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.
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 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
Preferred
Phlebotomy experience.
Sample collection experience.
Red Cap experience
LICENSES AND CERTIFICATES
Preferred
Clinical Research Coordinator Certification.
SKILLS
Required
Proficient communication skills
Maintains a high degree of professionalism
Demonstrated 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
Preferred
Proficient use of Excel
Organized and a strong ability to multi-task between multiple studies and locations
Strong written and verbal communication skills to interact with patients, sponsors, physicians, nurses, and team members
Ability to work with others and patients
Ability to encourage and be the cheer leader for the team
Ability to assist with increasing enrollment numbers for studies
Demonstrates self-motivation
Ability to take on the work and develop the collection and point of care team for clinical research
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.
Requires going to multiple sites in 1 day.
Required to transport samples between multiple collection sites on campus (Eskenazi, Methodist, University, Riley and Pathology Lab).
Work Location
Indianapolis, Indiana
Work Hours
8:00 am - 4:30 pm Monday through Friday
Benefits Overview
For 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 Classification
Career Level: Mastery
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research Click here to learn more about Indiana University's Job Framework.
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 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 Security
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 iups@iu.edu or by visiting IUPD.
