Clinical Research Coordinator
Indiana University

Department

PSYCHIATRY (IN-PSYC-IUINA)

Department Information

The Department of Psychiatry at Indiana University School of Medicine is committed to understanding the symptoms and neurobiological basis of mental illness and advancing psychiatric treatments through extensive involvement in basic and clinical research and patient care. The department is also involved with educating and training future leaders of psychiatry and behavioral science.

Indiana University School of Medicine is the largest medical school in the United States, with a large academic health center in downtown Indianapolis, the 17th largest city in the United States. In addition to having active sports, cultural, arts, and educational events and programs, Indianapolis is located centrally near several other major cities including Chicago, Louisville, Cincinnati, and Columbus.

As the nation's largest medical school, IUSM is committed to being an institution that not only reflects the diversity of the learners we teach and the patient populations we serve, but also pursues the values of diversity, equity and inclusion that inform academic excellence. We desire candidates whose work contributes to equitable and inclusive learning and working environments for our learners, staff, and faculty, as well as those whose work contributes to equitable and inclusive learning and working environments for our students, staff, and faculty. IUSM strives to take an anti-racist stance, regularly evaluating and updating its policies, procedures, and practices to confer equitable opportunities for contribution and advancement for all members of our community. We invite individuals who will join us in our mission to advance racial equity to transform health and wellbeing for all throughout the state of Indiana.

IU School of Medicine is closely aligned with our health system partner, IU Health, which has twice earned a place on the US News and World Report Honor Roll. The shared vision of both institutions is to lead the transformation of healthcare through quality innovation and education to make Indiana one of the nation's healthiest states. IU Health is among the top 10 largest single-state nonprofit health systems in the United States operating 16 hospitals statewide (a mix of urban, suburban and rural facilities). This partnership enables the seamless integration of research findings into patient care.

Job Summary

• 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

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.

Additional Information

Under the direct supervision of the Principal Investigator, the Clinical Research Coordinator will lead the day to day activities with regard to the smooth running of two outpatient medication clinical trials. The incumbent will be responsible for coordinating the activities of the study staff, including organizing team schedules and task assignments, as well as helping the PI in maintaining oversight of all data entry and IRB reporting procedures. In addition, the incumbent will help with participant screening, retention, scheduling, and medication compliance monitoring, as well as help administer clinical assessments and weekly counselling. Helps develop solutions to complex problems that impact the timeliness and accuracy of the conduct of the clinical research studies

Work Location

Indianapolis, Indiana

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: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research
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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.

Contact Us

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Telephone: 812-856-1234

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