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Senior Clinical Research Coordinator II
2 months ago
Senior Clinical Research Coordinator II (Research Studies Manager)
Hiring Department : Office of Population Health Sciences
Location : Chicago, IL USA
Requisition ID : 1026402
Posting Close Date : July 23, 2024
Description:
Position Summary -
SR Clinical Research Coordinator II (Research Studies Manager).
General Job Summary:
The Office of Population Health Sciences (OPHS) at UIC is seeking applications for a
Senior Clinical Research Coordinator II (Research Studies Manager).
This Position is responsible for managing and overseeing the day-to-day operations of clinical research studies, recruiting, scheduling and screening study participants, as well as documenting and reporting on the daily operations of assigned research studies/clinical trials. Working in collaboration with the Principal Investigator, the SR CRC II/Research Studies Manager is responsible for the oversight, facilitation and coordination of the daily research activities and plays a critical role in the conduct of the study. The SR CRC II/Research Studies Manager works collaboratively with the entire clinical research team, sponsors, and associates to ensure productivity, quality, and timely completion of studies. The SR CRC II/Research Studies Manager is expected to support, guide, train, demonstrate and lead clinical research team members in the implementation of clinical research related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical research studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards. They perform a variety of data management duties of a complex and technical nature in support of clinical research studies to ensure adherence to protocols and quality of information received.
Duties & Responsibilities
RESEARCH, DATA & PROTOCOL MANAGEMENT
Lead within the department to improve clinical research practices and operations across studies and serve as a resource to others.
Oversee and participate in coordinating and conducting complex clinical research studies, ensuring compliance with federal and institutional regulations.
Take initiative in establishing and coordinating the implementation of clinical research protocol priorities and organizational structure based on study needs, identifying areas for improvement.
Execute project goals and tasks as outlined in the project plan by actively assuming responsibility for components necessary for timely completion.
Lead protocol changes, assessing and coordinating with various departments to implement changes.
Maintain working knowledge of current protocols and internal Standard Operating Procedures (SOPs) and disseminate information on any changes to all stakeholders.
Collaborate with the Principal Investigator (PI), department, sponsor, and institution to support and guide the administration of compliance, financial, personnel, and other related aspects of clinical studies.
Prepare, submit, and assist Investigators with multiple levels of research documentation, including educational materials, reports, grant renewal reports, and study forms.
Prepare and evaluate protocols, manuscripts, reports, and dissemination tools.
Lead team efforts in collaboration with the Assistant Director of Compliance to complete all activities and ensure regulatory compliance, including leading on all Protocol Deviations (PDs), Adverse Events (AEs), and Notes to File (NTFs).
Collaborate with other research personnel with reports to regulatory agencies such as the IRB, FDA, and Data and Safety Review Committee.
Ensure validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.
Solve complex problems related to data management and the analysis of large administrative datasets.
Independently develop, manage, and report on key data, ensuring timeliness of data and reporting submissions from multiple investigators.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on collected data.
Actively collaborate with research call center agents to support efficient scheduling of research participants.
Delegate tasks to team members within the study program.
STRATEGIC PLANNING
Strategic planning and implementation of clinical study goals and objectives; organize patient enrollment planning; conduct quality assurance activities; compile and analyze data.
Lead the development and supervise the implementation of strategies for optimizing participant recruitment.
Analyze retention rates and formulate retention plans in collaboration with relevant stakeholders.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
FINANCIAL OVERSIGHT
Provide guidance on financial aspects of research studies which includes - participant compensation, billing analysis, and allocation of resources.
Work closely with the finance team to ensure accuracy of research study budget and burn rates.
COMMUNICATION
Act as a liaison with medical staff, University departments, ancillary departments, and satellite facilities.
Represent the PI and Clinical Study Team at national calls, satellite site meetings, and conferences/presentations.
Provide guidance to Investigators regarding protocol requirements.
STAFF SUPERVISION
Provide direct supervision of other Clinical Research staff, including hiring, performance evaluations, disciplinary actions, and approving time off.
Develop and implement training programs and standard operating procedures.
Train and support study team members on communication and teamwork best practices.
Accountable for high standards of clinical research practice and assists in developing accountability in others.
Oversee the completion of all protocol labs; provide backup coverage for site visits.
Other related duties as assigned.
Qualifications:
Minimum Qualifications:
Masters Degree in social sciences, public health, nursing, mental health, psychology, pharmaceutical sciences, social science, or a related field.
At least 7 years of experience conducting human participant research.
Highly developed written and verbal communication skills.
Knowledge of research protocols, principles, and procedures.
Knowledge of aspects of clinical trials such as screening, interviewing, and case report forms.
Knowledge of experimental design, mathematics, statistics, computer applications, and data management.
Knowledge of research-related clinical tasks (e.g., phlebotomy, centrifugation, interviewing).
Knowledge of ethics and regulatory procedures (i.e., informed consent, IRB applications, data safety and monitoring plans) involved with clinical trials and other clinical research.
Comfort working with Zoom/virtual facilitation.
Preferred Qualifications:
Prior experience with medical terminology and procedures, including electronic medical records and billing.
Ability to manage multiple tasks and deadlines.
Ability to work in a flexible environment with shifting priorities.
Excellent organizational skills with email, web messaging, and calendar and the ability to create and manage cloud documents.
Strong time management and multitasking abilities.
Proficient in Microsoft Office and Windows OS.
Experience with research in underrepresented communities.
Certified Clinical Research Coordinator (CCRC), ACRP, SOCRA.
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