Clinical Research Coordinator Jobs

PULMONARY (IN-PULM-IUINA)

The Indiana University School of Medicine is the largest medical school in the US and is annually ranked among the top medical schools in the US by US News & World Report. Researchers in the Division of Pulmonary Medicine at the IU School of Medicine pursue a variety of basic, translational and clinical research projects in the fields of pulmonary and critical care medicine.

Studies are conducted in facilities located on the school’s Indianapolis campus, its affiliated hospitals and in collaboration with investigators in other IU School of Medicine divisions and centers and at other academic institutions. Division research is funded by the National Institutes of Health, the Department of Veterans Affairs, non-profit organizations, foundations and industry.

Inclusive excellence is one of the main pillars of Indiana University Division of Pulmonary, Critical Care, Sleep & Occupational Medicine’s strategic plan and we strive to recruit, nurture, and retain diverse and highly skilled individuals. We recognize that we perform better on all aspects of our mission when faculty, staff, administrators, and learners reflect the diversity, and understand the needs of the people we serve in both clinical and research aspects.

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of one or more Principal Investigators (PI) within the division, across a range of studies in pulmonary, critical care, and sleep medicine. The potential areas of research may include disparities in lung cancer, asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), pulmonary hypertension, and sleep apnea. This exciting position offers an opportunity for someone who may be interested in health equity and health outcomes clinical and translational research.

Department-Specific Responsibilities

• Collaborates with the PI in preparation of categorized budget and justifications, as well as confirms the accuracy and completeness of study budget accounts.
• While the PI(s) will be primarily responsible for the overall design, conduct, and management of the studies, the CRC facilitates, supports, and coordinates the daily activities of the research studies and plays a critical role in the conduct of these studies
• Collaborates with the PI in study feasibility assessments.

General Responsibilities

• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• 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.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Stays up to date with knowledge of regulatory affairs and/or issues.
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• 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).
• 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.

EDUCATION / WORK EXPERIENCE

Required

• Bachelor's degree in science or a health-related field and 2 years of clinical research experience OR
• Associate degree in science or a health-related field and 3 years of clinical research experience

Combinations of related education and experience may be considered

LICENSES AND CERTIFICATES

Preferred

• SOCRA/ARCP Clinical Research Certification upon date of hire

SKILLS

Required

• Demonstrated analytical skills
• Excellent organizational skills
• Demonstrates a high commitment to quality
• Ability to simultaneously handle multiple priorities
• Possesses strong technical aptitude

Preferred

• Highly motivated
• Eager and willing to work on a team
• Possesses an interest in participating in clinical research
• Ability to relate to patients
• Exceptional people 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.

This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.

This position may be eligible for a sign-on bonus.

Indianapolis, Indiana

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Additional supplemental retirement plan options
• Dental insurance
• Base retirement plan contribution from IU, subject to vesting
• Life insurance, LTD, and AD&D options
• Health Savings Account with generous IU contribution
• Tuition benefit for IU classes
• Generous Paid Time Off
• Employee Assistance Program (EAP)
• Multiple plan options for medical insurance
• Paid Parental Leave
• 10 paid holidays per year

Learn more about our benefits by reviewing our online Benefits Brochure.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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.

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New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.

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.

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