Clinical Research Coordinator

About the Job

Position Summary:

The Clinical Research Coordinator provides overall study management for research faculty on a variety of research studies to include; business and industry studies, investigator-initiated studies and NIH sponsored research. This position reports to the Dermatology Clinical Research Division Program Manager.

The research coordinator will manage research projects across the Department of Dermatology. The coordinator will be a member of the Department of Dermatology Clinical Research Division. In addition, the position collaborates with other areas of the University to include Clinical Transitional Science Institute (CTSI) clinical research services, and the staff in the Dermatology clinics, research clinics and research laboratories in assuring that studies meet regulatory requirements, policies and procedures and are completed according to study protocols.

Major Duties/

Job Description:

Clinical Research Conduct and Facilitation (50%):

* Be primary contact and information resource to University faculty and staff for protocol specific queries, including enrollment requirements, specimens needed, etc.

* Engage with investigators and ensure research procedures comply with regulations, policies, and best practices.

* Provide effective specimen management, including preparing kits, processing specimens, preparing shipments, tracking inventory, etc.

* Work with investigators to ensure subject eligibility, facilitate subject enrollments, ensure the appropriate recording of adverse events, and timely acquisition of research tissue.

* Coordinate subject visits, ensure protocol requirements are met.

* Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.

* Facilitate the timely review and reporting of adverse reactions and severe adverse events.

* Ensure compliance with requirements for registering subjects and study visits; facilitate compliant research billing of services.

* Contribute to the production of research publications or presentations of research data.

* Enter all study and subject data into OnCore clinical trials management system and required sponsor platforms.

Research Regulatory Management (15%):

* Serve as the primary contact for the completion of required regulatory documentation.

* Manage regulatory submissions and approvals; respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. Track all regulatory review submissions to ensure deadlines are met.

* In collaboration with the PI, interpret study protocols and develop consent form documents needed for each clinical research study in conjunction with central CTSI regulatory assistance.

* Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time.

* Provide regulatory guidance and direction to all members of the research team to ensure compliance with applicable policies, procedures, and regulations.

* Ensure training requirements are met for all study team members.

* Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.

* Report Unanticipated Problems according to University policy.

Recruitment of research subjects (25%):

* In collaboration with the PI ensure recruitment activities are in line with the population and reach the intended audience:

* Identify recruitment material needs for the study population.

* Develop or modify existing recruitment material to reach the intended population.

* Ensure recruitment plan is approved by the sponsor and IRB.

* Ensure the recruitment materials are implemented (media, print and digital).

* Review recruitment plan throughout the study and adjust as needed.

* Implement a pre-screening plan and enrollment flow for potential subjects.

Administration (5%):

* Provide support and assistance to the clinical research team as directed.

* Support quality improvement initiatives.

* Attend weekly clinical research meetings.

Education (5%):

* Attend Research Professional Development Seminars and other educational opportunities as appropriate.

* Engage with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.

* Attend study, department education and national meetings to support the projects.

Qualifications

All required qualifications must be documented on application materials.

Required

Qualification:

* Bachelors' degree and 4 years of clinical or research experience OR advanced degree plus at least two years of relevant experience OR a combination of related education and work experience to equal 8 years.

* Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good…