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Clinical Research Coordinator 2 – Otolaryngology Ear, Nose, Throat

Rush University Medical Center

This is a Contract position in Chicago, IL posted July 28, 2019.

Job Title: Clinical Research Coordinator 2
– Otolaryngology Ear, Nose, Throat Department: Shift: 1st Specialty: Otolaryngology Job Number: 2019-0780 Date Posted: 07/03/2019 Position Type: Research Job Qualifications: At Rush University Medical Center, we are committed to advancing scientific medical knowledge through research.

We are revitalizing our medical centers with an emphasis on productivity, transparency and accountability.

Are you looking to be a part of the exciting, always evolving and expanding new developments in research here at Rush University Medical Center?

Are you well experienced in working with a variety of group, single and industry oriented studies?

If this describes you, you may be the right candidate for the Clinical Research Coordinator 2 position with Otolaryngology
– Ear, Nose, and Throat (ENT).

Position Highlights: The Clinical Research Coordinator II works under the general direction of the Office of Research Affairs’ Clinical Research Administration Division, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-Investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the principles of Good Clinical Practice (GCP) .S/he will coordinate clinical research studies and perform a variety of duties involved in the collection, compilation, and documentation of clinical research data.

S/he plays an instrumental role in facilitating the informed consent process and ensuring compliance with the study protocol.

The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Position Responsibilities: Adheres to the policies, procedures, and guidelines instituted by the Office of Research Affairs and the Office of Research Compliance.

h Manages multiple complex clinical research protocols concurrently including, but not limited to grant-funded research, externally sponsored clinical research, and investigator-initiated clinical research conducted on site at Rush or its affiliated sites .

Trains, mentors, and supervises entry level Clinical Research Coordinators, Research Protocol Coordinators, students, residents, and fellows on the basics of clinical research, GCP, Good Documentation Practices (GDP), and Rush SOPs.

Works closely with the Principal Investigator to coordinate all aspects of conducting clinical trials including screening, enrollment, and study subject visits.

Assists the Principal Investigator and Department/Research Administrator to review the protocol plan to develop the budget and differentiate the standard of care versus research charges while ensuring all potential costs of the trial are identified and covered by a funding source.

In conjunction with the Clinical Research Administration Division and Principal Investigator, determines the appropriate patient population, recruits, and maintains the target number of subjects for trial participation.

Updates the Clinical Research Administration Division, as necessary.

Maintains accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant IRB approvals, source documentation, Case Report Forms (CRFs), Delegation of Authority logs, protocol training log, and study related communications.

Partners with the study sponsor and Principal Investigator to complete study closure activities such as notification to study subjects, IRB, Clinical Research Administration Division, and Department/Research Administrator.

Communicates with study subject regarding subject procedures and visit schedule.

Works closely with the Clinical Research Administration Division to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance within study sponsor, Principal Investigator, and regulatory agency specifications.

Organizes and attends site monitoring visits conducted by internal and external auditors/monitors.

May obtain, process, transport and ship potentially bio-hazardous specimens to appropriate laboratory according to protocol and regulatory requirements Performs a variety of duties involved in the collection, compilation, and documentation of clinical research data.

Follows FDA, OHRP, and Rush guidelines in the collection of clinical data and/or administration of clinical studies.

May perform informed consent process for subject enrollment.

Documents all study subject interactions in the subject’s research records.

Coordinates the submission or submits documents, study protocols, and study protocol amendments to the local IRB per policy and procedure.

Performs other duties as assigned.

Position Qualifications: Bachelor’s degree in Science/ Health Related Field is required.

Certification as a Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professionals (CIP) is preferred.

Demonstrated knowledge of Good Clinical Practice (GCP) is required.

A minimum of 3 years of clinical research experience is required.

Company Highlights: Ranked among the top academic medical centers in the country, Rush University Medical Center is an outstanding place to enhance your career.

Everything we do centers on one goal: improving patient care.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded Rush full accreditation for three years.

Rush is one of the first academic medical centers in Illinois to receive this accreditation.

As an academic medical center, Rush University Medical Center in Chicago, Illinois, is committed to advancing medical knowledge through research.

Investigators at Rush are involved in more than 1,600 projects, including hundreds of clinical studies to test the effectiveness and safety of new therapies and medical devices, as well as to expand scientific and medical knowledge.

RUMC offers a competitive salary, outstanding benefits & the professional advantages of an environment that supports your development & recognizes your achievements.

Rush University is home to one of the first medical colleges in the Midwest and one of the nation’s top-ranked nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research.

Rush University Medical Center is an Equal Opportunity Employer that welcomes and encourages all applicants to apply regardless of age, race, sex, religion, color, national origin, disability, veteran status, sexual orientation, gender identity and/or expression, marital or parental status, ancestry, citizenship status, pregnancy or other reason prohibited by law.

At Rush University Medical Center, we are committed to advancing scientific medical knowledge through research.

We are revitalizing our medical centers with an emphasis on productivity, transparency and accountability.

Are you looking to be a part of the exciting, always evolving and expanding new developments in research here at Rush University Medical Center?

Are you well experienced in working with a variety of group, single and industry oriented studies?

If this describes you, you may be the right candidate for the Clinical Research Coordinator 2 position with Otolaryngology
– Ear, Nose, and Throat (ENT).

Position Highlights: The Clinical Research Coordinator II works under the general direction of the Office of Research Affairs’ Clinical Research Administration Division, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-Investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the principles of Good Clinical Practice (GCP) .S/he will coordinate clinical research studies and perform a variety of duties involved in the collection, compilation, and documentation of clinical research data.

S/he plays an instrumental role in facilitating the informed consent process and ensuring compliance with the study protocol.

The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Position Responsibilities: Adheres to the policies, procedures, and guidelines instituted by the Office of Research Affairs and the Office of Research Compliance.

h Manages multiple complex clinical research protocols concurrently including, but not limited to grant-funded research, externally sponsored clinical research, and investigator-initiated clinical research conducted on site at Rush or its affiliated sites .

Trains, mentors, and supervises entry level Clinical Research Coordinators, Research Protocol Coordinators, students, residents, and fellows on the basics of clinical research, GCP, Good Documentation Practices (GDP), and Rush SOPs.

Works closely with the Principal Investigator to coordinate all aspects of conducting clinical trials including screening, enrollment, and study subject visits.

Assists the Principal Investigator and Department/Research Administrator to review the protocol plan to develop the budget and differentiate the standard of care versus research charges while ensuring all potential costs of the trial are identified and covered by a funding source.

In conjunction with the Clinical Research Administration Division and Principal Investigator, determines the appropriate patient population, recruits, and maintains the target number of subjects for trial participation.

Updates the Clinical Research Administration Division, as necessary.

Maintains accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant IRB approvals, source documentation, Case Report Forms (CRFs), Delegation of Authority logs, protocol training log, and study related communications.

Partners with the study sponsor and Principal Investigator to complete study closure activities such as notification to study subjects, IRB, Clinical Research Administration Division, and Department/Research Administrator.

Communicates with study subject regarding subject procedures and visit schedule.

Works closely with the Clinical Research Administration Division to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance within study sponsor, Principal Investigator, and regulatory agency specifications.

Organizes and attends site monitoring visits conducted by internal and external auditors/monitors.

May obtain, process, transport and ship potentially bio-hazardous specimens to appropriate laboratory according to protocol and regulatory requirements Performs a variety of duties involved in the collection, compilation, and documentation of clinical research data.

Follows FDA, OHRP, and Rush guidelines in the collection of clinical data and/or administration of clinical studies.

May perform informed consent process for subject enrollment.

Documents all study subject interactions in the subject’s research records.

Coordinates the submission or submits documents, study protocols, and study protocol amendments to the local IRB per policy and procedure.

Performs other duties as assigned.

Position Qualifications: Bachelor’s degree in Science/ Health Related Field is required.

Certification as a Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professionals (CIP) is preferred.

Demonstrated knowledge of Good Clinical Practice (GCP) is required.

A minimum of 3 years of clinical research experience is required.

Company Highlights: Ranked among the top academic medical centers in the country, Rush University Medical Center is an outstanding place to enhance your career.

Everything we do centers on one goal: improving patient care.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded Rush full accreditation for three years.

Rush is one of the first academic medical centers in Illinois to receive this accreditation.

As an academic medical center, Rush University Medical Center in Chicago, Illinois, is committed to advancing medical knowledge through research.

Investigators at Rush are involved in more than 1,600 projects, including hundreds of clinical studies to test the effectiveness and safety of new therapies and medical devices, as well as to expand scientific and medical knowledge.

RUMC offers a competitive salary, outstanding benefits & the professional advantages of an environment that supports your development & recognizes your achievements.

Rush University is home to one of the first medical colleges in the Midwest and one of the nation’s top-ranked nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research.

Rush University Medical Center is an Equal Opportunity Employer that welcomes and encourages all applicants to apply regardless of age, race, sex, religion, color, national origin, disability, veteran status, sexual orientation, gender identity and/or expression, marital or parental status, ancestry, citizenship status, pregnancy or other reason prohibited by law.