Clinical Research Coordinator
Indiana University, Indianapolis, IN, United States
Overview
MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for NIH Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
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 Principal Investigator (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:
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: Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire.
Skills
Demonstrates analytical skills.
Ability to simultaneously handle multiple priorities.
Possesses strong technical aptitude.
Demonstrates a high commitment to quality.
Excellent organizational skills.
Additional Information
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 grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds. This position is not eligible for visa sponsorship. IU Indianapolis. This position is eligible for remote work, subject to change in the future based on university policy and business needs. Salary range: $56,874.80 - 66,874.80 per year based on experience and internal equity within the department.
Benefits (Full-time Staff)
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
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 iups@iu.edu or by visiting IUPD.
Request Support
Telephone: 812-856-1234
#J-18808-Ljbffr
MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for NIH Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
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 Principal Investigator (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:
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: Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire.
Skills
Demonstrates analytical skills.
Ability to simultaneously handle multiple priorities.
Possesses strong technical aptitude.
Demonstrates a high commitment to quality.
Excellent organizational skills.
Additional Information
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 grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds. This position is not eligible for visa sponsorship. IU Indianapolis. This position is eligible for remote work, subject to change in the future based on university policy and business needs. Salary range: $56,874.80 - 66,874.80 per year based on experience and internal equity within the department.
Benefits (Full-time Staff)
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
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 iups@iu.edu or by visiting IUPD.
Request Support
Telephone: 812-856-1234
#J-18808-Ljbffr