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Rush University Medical Center · 14 hours ago

Clinical Research Regulatory Coordinator-21135

Chicago, IL

Full-time

Onsite

Entry, Mid Level

$25.20/hr - $35.60/hr

2+ years exp

Rush University Medical Center is a leading institution in pediatric neurology research, and they are seeking a Clinical Research Regulatory Coordinator to provide regulatory support for multiple clinical research studies. The role involves preparing regulatory submissions and ensuring compliance with applicable regulations throughout the studies.

Clinical TrialsEducationHealth CareMedicalTraining

Responsibilities

Supports multiple clinical research studies, which may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator initiated studies

Writes and prepares IRB regulatory submissions, including but not limited to consent forms, new project applications, continuing review applications and unanticipated problems

Communicates with IRB and finalizes documents based on IRB comments and recommendations to ensure IRB approval of study

Coordinates submissions to ancillary committees such as Protocol Review and Monitoring Committee, Radiation Safety Committee, and Institutional Biosafety Committee

Provide ongoing study status updates, responds to questions and may create summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study

Collaborates with study team to ensure implementation of amendments, awareness of safety, and protocol changes and document version control

Serves as the primary regulatory contact for studies to ensure that regulatory files are audit-ready

Works closely with the Office of Research Affairs and Research Compliance to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, Principal Investigator, and regulatory agency specifications

May collaborate with study investigators, nurses, study coordinators, and study sponsors to coordinate study start-up activities, which include collection and distribution of regulatory, budget, contract, and coverage analysis documents

Maintains accurate records related to the regulatory aspects of clinical research

May coordinate timely investigator assessment of safety reports

Proactively identifies regulatory issues and/or variances with study protocols and recommends process improvements

May train new research coordinators on basics of regulations applicable to clinical research and lead presentations

Maintains current knowledge of industry trends

Coordinates department or clinic compliance

Directs compliance documentation submission and maintenance

Qualification

Human Subjects researchRegulatory submissionsClinical PracticeClinical research experienceMicrosoft Office SuiteAdobe AcrobatCertified Clinical Research ProfessionalAnalytical skillsCustomer service orientationProblem-solvingCommunication skillsTeam collaboration

Required

Bachelor's degree

2-4 years clinical experience

2 years coordinating Human Subjects research

Must demonstrate proficiency with the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report and HIPAA, and RUCC policies and procedures

Demonstrated problem-solving, critical decision makings and professional judgement

Strong analytical skill with a high attention to details

Clear and concise verbal and written communication with ability to communicate complex concepts for a wide range of individuals in a cross-functional environment

Demonstrated ability to collaborate within multi-disciplinary teams, customer service oriented

Ability to meet deadlines and coordinate multiple aspects of the ongoing project

Ability to manage stressful situations

Proficiency with Microsoft Office Suite

Proficiency with Adobe Acrobat

Requires a commitment to customer service and the ability to work effectively and collaboratively in a complex academic environment

Preferred

Bachelor's degree in Health Sciences or related discipline

Master's degree in science or health related field

2 years of years of clinical research experience, in the academic or pharmaceutical clinical trials environment

Relevant certification as a Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) strongly preferred or required within 1 year of employment