Clinical Research Coordinator

Indiana University BloomingtonIndianapolis, Indiana

Hace más de 30 días

Tipo de contrato

A tiempo completo

Descripción del trabajo

Job Summary

Department-Specific Responsibilities

Coordinates various research studies. Identifies potential survey subjects. Oversees patient medically related activities from diagnosis to post care. Performs screenings, conducts interviews, completes consents, leads site visits, tracks discharge and post care.
Tracks patient and study activities. Enters data for referrals, surgical data, neonatal tracking, and study follow up. Generates reports utilizing collected data.
Performs outreach and marketing activities to identify potential patients for studies. Conducts interviews and reviews patient information to confirm study eligibility.
Advises the principal investigator (PI) of potential protocol deviations. Helps PI to problem solve and assess.
Contacts stakeholders (PI, providers, study participants, etc.) for completing study documentation.
Adheres to regulatory protocols, procedures, and study requirements. Informs PI, departmental Regulatory Specialist, etc. of potential concerns.
Develops marketing materials to attract participants to studies.

General 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 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.

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 2 years of clinical research experience OR

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

LICENSES AND CERTIFICATES

Preferred

SOCRA / ARCP Clinical Research Certification upon date of hire

SKILLS

Required

Demonstrated analytical skills

Ability to simultaneously handle multiple priorities

Possesses strong technical aptitude

Demonstrates a high commitment to quality

Excellent organizational skills

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.

Work Location

Indiana University School of Medicine

Department of Obstetrics and Gynecology

11 30 West Michigan Street

Fesler Hall, FH204

Indianapolis, Indiana 46202

Benefits Overview

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.

Job Classification

Career Level : Career

FLSA : Exempt

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 opportunity employer and provider of ADA services and prohibits discrimination in hiring.See Indiana University Notice of Non-Discrimination here which includes contact information.

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Clinical Research Coordinator • Indianapolis, Indiana