Job Description

Location: Chicago, IL

Hospital: RUSH University Medical Center

Department: ER Research Recruit - Corbin

Work Type: Full Time (Total FTE between 0.9 and 1.0)

Shift: Shift 1

Work Schedule: 8 Hr (8:00:00 AM - 5:00:00 PM)

Summary:

This position oversees the regulatory components of multiple and/or complex clinical research studies. Serves as a resource to train and mentor newer research coordinators. Help facilitate the process of assessing, streamlining, and prioritizing the regulatory administrative aspect of protocol management. Provides indirect oversight to clinical research staff within the department. The incumbent exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Responsibilities:

• Supports multiple/complex 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.

• Reviews and finalizes documents based on IRB comments and recommendations and ensures IRB approval of study.

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

• Reviews and finalizes summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance and ensures accurate study updates are provided 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.

• Reviews regulatory files to ensure they are audit-ready.

• In partnership with the Office of Research Affairs and Research Compliance ensures Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, Principal Investigator, and regulatory agency specifications.

• Works closely with study investigators, nurses, study coordinators, and study sponsors to manage team involvement with study start-up activities, which include collection and distribution of regulatory, budget, contract, and coverage analysis documents.

• Ensures accuracy of records related to the regulatory aspects of clinical research.

• Oversees coordination of timely investigator assessment of safety reports.

• Provides recommendations to proactively address complex regulatory issues, process improvements, and/or variances with study protocols.

• Trains and mentor, entry level Clinical Research Coordinators, Regulatory Coordinators, Research Protocol Coordinators, students, residents, and fellows on the basics of regulations applicable to clinical research.

• Maintains current knowledge of industry trends

• Summarizes and shares relevant industry information during internal and external presentations.

• Manages special projects.

• Develops departmental processes and procedures.

• Plans and executes internal and external audits and activities to support regulatory agency inspections.

Other information:

Required Job Qualifications:

• Bachelor’s degree.

• 5 years of clinical research experience.

• 4 years coordinating Human Subjects research.

• Relevant certification as a Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) upon hire or within six months of hire.

• Must demonstrate advanced knowledge of 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 RUMC policies and procedures.

• Demonstrated problem-solving, critical decision makings and professional judgement.

• Strong analytical and organizational skills with a high attention to details

• Clear and concise verbal and written communication with ability to communicate complex concepts.

• Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality.

• Demonstrated ability to collaborate within multi-disciplinary team settings, customer service oriented

• Ability to lead a team.

• Ability to manage stressful situations.

• Strong project management skills including the ability to meet deadlines and coordinate multiple aspects of the ongoing project

• 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 Job Qualifications:

• Master’s degree in science or health related field.

• 4 years of clinical research experience in the academic or pharmaceutical clinical trials environment.

• Supervisory experience.

Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Position Senior Clinical Research Regulatory Coordinator

Location US:IL:Chicago

Req ID 3758