Clinical Research Specialist

3 weeks ago

Indianapolis, Indiana, United States Indiana University Full time

CANCER CENTER (IN-CANC-IUINA)



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.

  • Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
  • Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects; coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
  • Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
  • Monitors study team compliance with protocol and SOPs; submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
  • Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
  • Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
  • Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
  • May provide guidance and/or support to less experience clinical research staff.


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 1 year of health-related or research experience; OR
  • Associate's degree in an allied health profession and 3 years of health-related or research experience

SKILLS

Required

  • Proficient communication skills
  • Maintains a high degree of professionalism
  • Demonstrated time management and priority setting skills
  • Demonstrates a high commitment to quality
  • Possesses flexibility to work in a fast paced, dynamic environment
  • Highly thorough and dependable
  • Possesses a high degree of initiative
  • Ability to build strong customer relationships


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 may be eligible for a sign-on bonus.



IUSCCC Clinical Trials Office

IUPUI Campus

Indianapolis, Indiana



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 .



Career Level: Mastery

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

Click here to learn more about Indiana University's Job Framework.



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.



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 .



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 [email protected] or by visiting IUPD.



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