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Clinical Research Coordinator at Indiana University

Clinical Research Coordinator

Indiana University Indianapolis, IN Full-Time
Department

PLASTIC SURGERY (IN-SPLA-IUINA)

Department Information

The Department of Surgery is the third largest Department within Indiana University School of Medicine (IUSM). We are committed to the education and development of excellent surgical clinicians, incorporating the skills, knowledge and competencies essential for providing a high standard of care to residents across the state of Indiana and beyond. Faculty educators in the Department of Surgery strive to advance surgical scientists and their research and aim to instill the leadership qualities that will empower graduates to excel in all practice settings.

To learn more about the Department of Surgery, please view this link here.

As a Clinical Research Coordinator, you will provide dedicated support to the Indiana Center for Regenerative Medicine and Engineering (ICRME) which is a multidisciplinary research center focused on the development of novel technologies that regenerate cells and tissues affected by age, disease, damage or congenital effects, ultimately leading to wound care and healing for patients in Indiana and beyond. The center is comprised of more than 30 scientists and staff working to reduce the number of amputations in the state of Indiana and deliver critically acclaimed science.

To learn more about the ICRME, please view this link here.

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 who enhance our representational diversity, 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 well-being for all throughout the state of Indiana.

Job Summary

Note: This is a grant funded opportunity.

General Responsibilities:
  • 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

EDUCATION / WORK EXPERIENCE

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
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.

Selected candidate must be up-to-date on all immunizations and will be required to complete a pre-employment health screening. May also be working with Covid-19 patients.

Work Location

Indianapolis, 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.

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 [ Email address blocked ] - Click here to apply to Clinical Research Coordinator or by visiting IUPD.

Contact Us

Request Support
Telephone:
812-856-1234

Recommended Skills

  • Analytical
  • Assessments
  • Clinical Research
  • Clinical Study Design
  • Communication
  • Coordinating
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