Clinical Research Coordinator, Infectious Diseases

INFECTIOUS DISEASES (IN-INFD-IUINA)

The Division of Infectious Diseases is home to over 30 full-time faculty, 10 affiliate faculty, 5 Advanced Practice Providers, 4 - 6 Accreditation Council for Graduate Medical Education (ACGME) fellows and over 30 full-time staff directly supporting all 3 missions of research, education, and clinical practice. The fellowship program is ACGME accredited and combines excellent clinical and academic training. We play an active role in the education of learners from the medical student level through fellowship.

Clinical practice takes place at 5 hospitals within the Indiana University Health (IUH) System, Eskenazi Health Hospital (Marion County's safety net hospital), the Roudebush VA, and specialized care at the bone marrow transplant unit at St. Francis Hospital and orthopedic complications at OrthoIndy.

The Division has a rich history in research and currently has over $7.6 million in extramural funding from the NIH and industry. We hold several endowments including an endowed chair, and endowed fellowship position, and an endowment which supports research related to HIV.

Department-Specific Responsibilities

• Conducts STI clinical research coordination.
• Identifies, recruits and selects clinical research study participants.
• Performs subject interviews and assessments for data.
• Conducts informed consent discussions.
• Determines and uses best practices and techniques to meet enrollment goals.
• Collects and reviews study data and samples.
• Organizes and enters data into appropriate systems.
• Identifies and reports adverse events.
• Records, documents and reports protocol deviations.
  
  

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).
• 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.
  
  

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.

Required

EDUCATION / WORK EXPERIENCE

• 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 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
  
  

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 not eligible for visa sponsorship.

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

Indianapolis, Indiana

$57,000 - $67,000 per year based on experience and internal equity.

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

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)
  
  

Learn more about our benefits by reviewing the IU Benefit Programs Brochure.

Career Level: Career

FLSA: Exempt

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 opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University 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.

Request Support

Telephone: 812-856-1234

INFECTIOUS DISEASES (IN-INFD-IUINA)

The Division of Infectious Diseases is home to over 30 full-time faculty, 10 affiliate faculty, 5 Advanced Practice Providers, 4 - 6 Accreditation Council for Graduate Medical Education (ACGME) fellows and over 30 full-time staff directly supporting all 3 missions of research, education, and clinical practice. The fellowship program is ACGME accredited and combines excellent clinical and academic training. We play an active role in the education of learners from the medical student level through fellowship.

Clinical practice takes place at 5 hospitals within the Indiana University Health (IUH) System, Eskenazi Health Hospital (Marion County's safety net hospital), the Roudebush VA, and specialized care at the bone marrow transplant unit at St. Francis Hospital and orthopedic complications at OrthoIndy.

The Division has a rich history in research and currently has over $7.6 million in extramural funding from the NIH and industry. We hold several endowments including an endowed chair, and endowed fellowship position, and an endowment which supports research related to HIV.

Department-Specific Responsibilities

• Conducts STI clinical research coordination.
• Identifies, recruits and selects clinical research study participants.
• Performs subject interviews and assessments for data.
• Conducts informed consent discussions.
• Determines and uses best practices and techniques to meet enrollment goals.
• Collects and reviews study data and samples.
• Organizes and enters data into appropriate systems.
• Identifies and reports adverse events.
• Records, documents and reports protocol deviations.
  
  

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).
• 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.
  
  

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.

Required

EDUCATION / WORK EXPERIENCE

• 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 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
  
  

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 not eligible for visa sponsorship.

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

Indianapolis, Indiana

$57,000 - $67,000 per year based on experience and internal equity.

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

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)
  
  

Learn more about our benefits by reviewing the IU Benefit Programs Brochure.

Career Level: Career

FLSA: Exempt

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 opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University 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.

Request Support

Telephone: 812-856-1234