Clinical Research Coordinator
About the role
The Division of Cardiovascular Medicine in the Department of Medicine strives for excellence in research, education, and patient care. The division's physicians, staff members, and learners work to reduce the burden of cardiovascular disease for Hoosiers, offering the highest quality care and fostering innovation that fuels better health for the people of Indiana and beyond.
Responsibilities
- Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
- 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.
- 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 sponsors.
- 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 Principal Investigator (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.
Requirements
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.
- 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.
Qualifications
- Demonstrates analytical skills.
- Ability to simultaneously handle multiple priorities.
- Possesses strong technical aptitude.
- Demonstrates a high commitment to quality.
- Excellent organizational skills.
- 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.
Skills
Preferred: Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire.
Benefits
- 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)
Schedule
This position is eligible for remote work or to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
Indianapolis, Indiana