Clinical Research Coordinator

Indiana University is an institution whose Division of Cardiovascular Medicine conducts cardiovascular research, education, patient care, and clinical trials. The Clinical Research Coordinator manages clinical research studies by supporting protocol review and design, participant recruitment and assessment, regulatory compliance, budgeting, adverse event reporting, and study documentation.

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 (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepares regulatory documents for sponsor

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

Preferred

Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire

Clinical Research Certification

Benefits

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.

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)

Company

University with nine campuses and online degree programs

Bloomington, Indiana, USA

https://www.iu.edu/

Founded in 1820

10001+ employees

Qualifications

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

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

Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire

Associate's degree in science or a health-related field and 3 years of clinical research experience.

Required skills

Represents the skills you have, click on the tags, SOCRA/ACRP Clinical Research Certification

Experience

2+ years