Clinical Research Coordinator at Indiana University

Posted in Other 7 days ago.

Location: Indianapolis, Indiana





Job Description:

Department



CANCER CENTER (IN-CANC-IUINA)



Department Information



The Clinical Trials Office is seeking applications for a Clinical Research Coordinator to support oncology-focused trials at IU Health West Hospital in Avon, Indiana. The 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



The CTO is seeking applications for our Clinical Research Coordinator position located at IU Health West Hospital in Avon, Indiana. This role coordinates sponsor-initiated and investigator-initiated oncology focused clinical trials for a disease-oriented team.


  • 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.


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



Qualifications



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

  • 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



IUSCCC Clinical Trials Office


IU Health West Hospital


Avon, Indiana



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



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.


If you wish to include a cover letter, you may include it with your resume when uploading attachments.



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.




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.



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