Clinical Research Coordinator 2

Updated: about 2 months ago
Location: Chicago, ILLINOIS
Job Type: FullTime

Department
 

BSD MED - Section Administrator: Hospital Medicine - CCP Clinical Research Staff


About the Department
 

The Clinical Research Coordinator 2 will be a member of the research team in Hospital Medicine, working on projects for the Comprehensive Care Program (CCP). CCP research includes several randomized trials that study the impact of having the same physicians care for patients at increased risk of hospitalization in both the inpatient and outpatient settings as well as understand and address unmet social needs. The Clinical Research Coordinator 2 will provide support to the research faculty in the Section of Hospital Medicine and within the Department of Medicine.


Job Summary
 

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, clinical research director/manager and/or the Office of Clinical Research (OCR).With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study. The CRC2 may assist with the training and/or mentoring of CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study

Responsibilities

  • Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
  • Recruit and interview potential study patients with guidance from PI and other clinical research staff.
  • Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
  • Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
  • Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
  • Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
  • Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
  • Performs assessments at visits and monitors for adverse events.
  • Organizes and attends site visits from sponsors and other relevant study meetings.
  • Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
  • Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
  • Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
  • Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
  • Ensures compliance with federal regulations and institutional policies.
  • May prepare and maintain protocol submissions and revisions.
  • May assist in the training of new or backup coordinators.
  • Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
  • Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
  • Performs other related work as needed.


Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

---
Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

---
Certifications:

---

Preferred Qualifications

Education:

  • Bachelors degree.

Experience:

  • 2 years of clinical research experience or relevant experience.

  • Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Preferred Competencies

  • Ability to be aware of safety hazards and take appropriate precautions.
  • Ability to communicate in writing.
  • Ability to communicate orally.
  • Ability to comprehend technical documents.
  • Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.
  • Ability to create and deliver presentations.
  • Ability to develop and manage interpersonal relationships.
  • Ability to exercise absolute discretion regarding confidential matters.
  • Ability to follow written and/or verbal instructions.
  • Ability to give directions.
  • Ability to handle sensitive matters with tact and discretion.
  • Ability to handle stressful situations.
  • Ability to learn and develop skills.
  • Ability to maintain a high level of alertness.
  • Ability to pay attention to detail.
  • Ability to perform multiple tasks simultaneously.
  • Ability to prioritize work and meet deadlines.
  • Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.
  • Ability to read.
  • Ability to train or teach others.
  • Ability to work effectively and collegially with little supervision or as member of a team.
  • Ability to work independently.

Application Documents

  • Resume (required)
  • Cover Letter (required)


When applying, the document(s) MUST  be uploaded via the My Experience page, in the section titled Resume/CV of the application.


Job Family
 

Research


Role Impact
 

Individual Contributor


FLSA Status
 

Exempt


Pay Frequency
 

Monthly


Scheduled Weekly Hours
 

37.5


Benefits Eligible
 

Yes


Drug Test Required
 

Yes


Health Screen Required
 

Yes


Motor Vehicle Record Inquiry Required
 

No


Posting Statement
 

The University of Chicago is an Affirmative Action/ Equal Opportunity /Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form .

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.



Department
 

BSD MED - Section Administrator: Hospital Medicine - CCP Clinical Research Staff


About the Department
 

The Clinical Research Coordinator 2 will be a member of the research team in Hospital Medicine, working on projects for the Comprehensive Care Program (CCP). CCP research includes several randomized trials that study the impact of having the same physicians care for patients at increased risk of hospitalization in both the inpatient and outpatient settings as well as understand and address unmet social needs. The Clinical Research Coordinator 2 will provide support to the research faculty in the Section of Hospital Medicine and within the Department of Medicine.


Job Summary
 

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, clinical research director/manager and/or the Office of Clinical Research (OCR).With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study. The CRC2 may assist with the training and/or mentoring of CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study

Responsibilities

  • Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
  • Recruit and interview potential study patients with guidance from PI and other clinical research staff.
  • Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
  • Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
  • Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
  • Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
  • Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
  • Performs assessments at visits and monitors for adverse events.
  • Organizes and attends site visits from sponsors and other relevant study meetings.
  • Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
  • Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
  • Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
  • Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
  • Ensures compliance with federal regulations and institutional policies.
  • May prepare and maintain protocol submissions and revisions.
  • May assist in the training of new or backup coordinators.
  • Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
  • Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
  • Performs other related work as needed.


Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

---
Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

---
Certifications:

---

Preferred Qualifications

Education:

  • Bachelors degree.

Experience:

  • 2 years of clinical research experience or relevant experience.

  • Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Preferred Competencies

  • Ability to be aware of safety hazards and take appropriate precautions.
  • Ability to communicate in writing.
  • Ability to communicate orally.
  • Ability to comprehend technical documents.
  • Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.
  • Ability to create and deliver presentations.
  • Ability to develop and manage interpersonal relationships.
  • Ability to exercise absolute discretion regarding confidential matters.
  • Ability to follow written and/or verbal instructions.
  • Ability to give directions.
  • Ability to handle sensitive matters with tact and discretion.
  • Ability to handle stressful situations.
  • Ability to learn and develop skills.
  • Ability to maintain a high level of alertness.
  • Ability to pay attention to detail.
  • Ability to perform multiple tasks simultaneously.
  • Ability to prioritize work and meet deadlines.
  • Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.
  • Ability to read.
  • Ability to train or teach others.
  • Ability to work effectively and collegially with little supervision or as member of a team.
  • Ability to work independently.

Application Documents

  • Resume (required)
  • Cover Letter (required)


When applying, the document(s) MUST  be uploaded via the My Experience page, in the section titled Resume/CV of the application.


Job Family
 

Research


Role Impact
 

Individual Contributor


FLSA Status
 

Exempt


Pay Frequency
 

Monthly


Scheduled Weekly Hours
 

37.5


Benefits Eligible
 

Yes


Drug Test Required
 

Yes


Health Screen Required
 

Yes


Motor Vehicle Record Inquiry Required
 

No


Posting Statement
 

The University of Chicago is an Affirmative Action/ Equal Opportunity /Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form .

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.


View or Apply

Similar Positions