Clinical Research Protocol Writer Jobs (NOW HIRING)

Senior Clinical Research Coordinator
Hiring Department: Neurology and Rehabilitation
Location: Chicago, IL USA
Requisition ID: 1042180
Posting Close Date:
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About the University of Illinois Chicago
UIC is among the nation's preeminent urban public research universities, a Carnegie RU/VH research institution, and the largest university in Chicago. UIC serves over 34,000 students, comprising one of the most diverse student bodies in the nation and is designated as a Minority Serving Institution (MSI), an Asian American and Native American Pacific Islander Serving Institution (AANAPSI) and a Hispanic Serving Institution (HSI). Through its 16 colleges, UIC produces nationally and internationally recognized multidisciplinary academic programs in concert with civic, corporate and community partners worldwide, including a full complement of health sciences colleges. By emphasizing cutting-edge and transformational research along with a commitment to the success of all students, UIC embodies the dynamic, vibrant and engaged urban university. Recent "Best Colleges" rankings published by U.S. News & World Report, found UIC climbed up in its rankings among top public schools in the nation and among all national universities. UIC has over 300,000 alumni, and is one of the largest employers in the city of Chicago.
This position is intended to be eligible for benefits. This includes Health, Dental, Vision, Life Insurance, a Retirement Plan, Paid time Off, and Tuition waivers for employees and dependents.
Position SummaryThe Clinical Research Coordinator manages and directs the coordination and timely handling of all components of clinical research protocols in and outside of the clinical setting. This position will develop and implement standards for research protocol management, policies, and procedures. Responsible for the implementation and conduct of multiple research projects. Coordinates comprehensive patient protocol treatment schedules to maintain compliance to protocol requirements. Develops and implements effective patient recruitment strategies, research budgets, and related fiscal planningDuties & Responsibilities• RESEARCH, Clinical Trials, 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.• Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee and grant sponsors.• Review laboratory and clinical procedures and evaluations regularly to ensure protocol compliance.• Act as liaison between physicians, clinical staff and the UIC IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.• Execute informed consent process and monitors patient status; Enroll participants into programs, explaining the research protocols to the clients and supporting family/friends, and obtain appropriate consent forms.• 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.
Minimum Qualifications
Bachelor's degree in science or related field required. Master's degree in science preferred.
A minimum of 5 years of experience in a research discipline required.
Experience in a clinical research setting, experience working with Federal Regulations and IRB's.
Ability to manage multiple tasks.
Strong interpersonal and customer service skills. Requires excellent communication, organization, presentation and computer/pc skills.
Preferred Qualifications
Master Degree Preferred
Knowledge of research protocols, principles and procedures; knowledge of aspects of clinical trials such as screening, interviewing, case reports forms; knowledge of experimental design, mathematics, statistics, computer applications and computer data management; oral and written communication skills;
Ability to identify, produce, organize, evaluate and interpret data; 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; ability to work as a member of a project team; knowledge of clinical tasks required for research (e.g. phlebotomy, centrifugation, interviewing
The University of Illinois System is an equal opportunity employer, including but not limited to disability and/or veteran status, and complies with all applicable state and federal employment mandates. Please visit Required Employment Notices and Posters to view our non-discrimination statement and find additional information about required background checks, sexual harassment/misconduct disclosures, and employment eligibility review through E-Verify.
The university provides accommodations to applicants and employees. Request an Accommodation
Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.