Clinical Research Coordinator
Company: Indiana University
Location: Indianapolis
Posted on: April 26, 2024
Job Description:
DepartmentCANCER CENTER (IN-CANC-IUINA)Department InformationThe
mission of the IU Simon Comprehensive Cancer Center (IUSCCC)
Clinical Trials Office (CTO) is to support and facilitate the
conduct of quality clinical research by IUSCCC translational
clinical investigators. The CTO is a centralized resource available
to all clinical investigators of the IUSCCC whose services enable
the safe and efficient conduct of adult and pediatric trials. The
CTO provides a comprehensive range of services. These services
begin in the early stages of protocol development and continue
throughout the study implementation, publication and long-term
follow-up.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.QualificationsCombinations 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
EXPERIENCERequired
- 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
CERTIFICATESPreferred
- SOCRA/ARCP Clinical Research Certification upon date of hire.
SKILLSRequired
- Demonstrated analytical skills.
- Ability to simultaneously handle multiple priorities.
- Possesses strong technical aptitude.
- Demonstrates a high commitment to quality.
- Excellent organizational skills.Working Conditions / DemandsThe
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
InformationThis position may be eligible for a sign-on bonus.Work
LocationIUSCCC Clinical Trials OfficeIU IndianapolisIndianapolis,
IndianaBenefits OverviewFor 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 ClassificationCareer
Level: CareerFLSA: ExemptJob Function: ResearchJob Family: Clinical
ResearchClick here to learn more about Indiana University's Job
Framework.Posting DisclaimerThis 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 OpportunityIndiana 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 SecurityThe 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 UsRequest SupportTelephone:
812-856-1234
Keywords: Indiana University, Lawrence , Clinical Research Coordinator, Healthcare , Indianapolis, Indiana
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