Clinical Research Operations Manager
University of Chicago, Chicago, IL, United States
About the Department
The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.
Job Summary
The Clinical Research Operations Manager is a specialized research professional responsible for the direction of research operations in the program. The position works closely with the Principal Investigator (PI) and ensures research projects progress according to plan by overseeing the coordination of daily clinical trial activities. The Manager oversees and assists in the development of study material, flowsheets and, while supervising trainees, nurses, coordinators and research assistants, participates in writing articles, reports and manuscripts and presenting research findings at meetings and conferences. By performing these duties, the Manager works with the PI, department, and institution to provide guidance on the administration of compliance, personnel and other related aspects of the clinical study.
Responsibilities
Maintain a high level of knowledge of all research protocols and the day-to-day function of the lab.
Oversee the operations of ongoing research projects, including all study materials, coordinating and performing study duties as needed.
Ensure research projects progress according to plan.
Investigate, modify and apply new procedures, techniques or applications of technology.
Establish goals and operating procedures, practices, and guidelines.
Participate as a skilled individual contributor and/or lead researcher as expert in specialized area.
Manage personnel, planning, compliance and other administrative aspects of research project(s).
Maintain laboratory supply inventory and perform ordering.
Oversee activities related to data collection and analysis.
Coordinate the conduct of the study from screening through to completion, including recruitment and screening of study subjects, obtaining informed consent, collecting and validating research data, and ensuring protocol adherence.
Protect patients and data confidentiality by ensuring security of research data and personal health information.
Ensure compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Understand the IRB submission and review process and facilitate study initiation through meticulous and timely preparation of IRB submissions.
Understand federal research regulations and identify the federal research organizations’ role in regulating human research participation.
Identify and explain responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Supervise and train research trainees, nurses, coordinators and research assistants.
Oversee day-to-day function of the program including team trainings, hours and meetings.
Participate in presenting research findings at meetings and conferences.
Plan and manage the protocol review process for all clinical trials, including receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitor federal regulatory agency requirements related to clinical research training requirements and ensure training activities comply with requirements.
Perform other related work as needed.
Qualifications
Education
Minimum requirements: a college or university degree in a related field.
Work Experience
Minimum requirements: 7+ years of experience in a related job discipline.
Preferred Qualifications
Master’s degree in a related field.
Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
Experience managing research teams and projects.
Experience in a leadership role.
Preferred Competencies
Ability to develop and manage clinical trials teams.
Excellent time management skills and ability to work independently.
Ability to develop research programs and work strategically with Principal Investigators.
Ability to lead robust operational and financial analysis of study(ies) and/or program performance.
Ability to understand clinical trials protocols.
Knowledge of regulatory policies and procedures.
Strong analytical skills.
Knowledge of grant and contract administration.
Familiarity with medical and scientific terminology.
Demonstrated knowledge of Good Clinical Practices (GCP).
Ability to identify funding sources.
Benefits
Benefits Eligible: Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Equal Opportunity Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
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The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.
Job Summary
The Clinical Research Operations Manager is a specialized research professional responsible for the direction of research operations in the program. The position works closely with the Principal Investigator (PI) and ensures research projects progress according to plan by overseeing the coordination of daily clinical trial activities. The Manager oversees and assists in the development of study material, flowsheets and, while supervising trainees, nurses, coordinators and research assistants, participates in writing articles, reports and manuscripts and presenting research findings at meetings and conferences. By performing these duties, the Manager works with the PI, department, and institution to provide guidance on the administration of compliance, personnel and other related aspects of the clinical study.
Responsibilities
Maintain a high level of knowledge of all research protocols and the day-to-day function of the lab.
Oversee the operations of ongoing research projects, including all study materials, coordinating and performing study duties as needed.
Ensure research projects progress according to plan.
Investigate, modify and apply new procedures, techniques or applications of technology.
Establish goals and operating procedures, practices, and guidelines.
Participate as a skilled individual contributor and/or lead researcher as expert in specialized area.
Manage personnel, planning, compliance and other administrative aspects of research project(s).
Maintain laboratory supply inventory and perform ordering.
Oversee activities related to data collection and analysis.
Coordinate the conduct of the study from screening through to completion, including recruitment and screening of study subjects, obtaining informed consent, collecting and validating research data, and ensuring protocol adherence.
Protect patients and data confidentiality by ensuring security of research data and personal health information.
Ensure compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Understand the IRB submission and review process and facilitate study initiation through meticulous and timely preparation of IRB submissions.
Understand federal research regulations and identify the federal research organizations’ role in regulating human research participation.
Identify and explain responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Supervise and train research trainees, nurses, coordinators and research assistants.
Oversee day-to-day function of the program including team trainings, hours and meetings.
Participate in presenting research findings at meetings and conferences.
Plan and manage the protocol review process for all clinical trials, including receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitor federal regulatory agency requirements related to clinical research training requirements and ensure training activities comply with requirements.
Perform other related work as needed.
Qualifications
Education
Minimum requirements: a college or university degree in a related field.
Work Experience
Minimum requirements: 7+ years of experience in a related job discipline.
Preferred Qualifications
Master’s degree in a related field.
Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
Experience managing research teams and projects.
Experience in a leadership role.
Preferred Competencies
Ability to develop and manage clinical trials teams.
Excellent time management skills and ability to work independently.
Ability to develop research programs and work strategically with Principal Investigators.
Ability to lead robust operational and financial analysis of study(ies) and/or program performance.
Ability to understand clinical trials protocols.
Knowledge of regulatory policies and procedures.
Strong analytical skills.
Knowledge of grant and contract administration.
Familiarity with medical and scientific terminology.
Demonstrated knowledge of Good Clinical Practices (GCP).
Ability to identify funding sources.
Benefits
Benefits Eligible: Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Equal Opportunity Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
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