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BSD MED - Pulmonary - Administration

About the Department

The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.

Job Summary

The Clinical Research Manager is a specialized research professional that is responsible for the direction clinical research activity within the Section of Pulmonary/Critical Care in the Department of Medicine.

Responsibilities

• Oversees the development of research projects.

• Ensures research projects progress according to plan.

• Investigates, modifies and applies new procedures, techniques or applications of technology.

• Establishes goals and operating procedures, practices, and guidelines.

• Establishes, monitors, and controls project budgets.

• In collaboration with research faculty and personnel, participates as a skilled individual contributor and/or researcher.

• Prepares grant/funding applications in collaboration with pre-award office.

• Manages financial activities and works closely with post-award office to obtain financial reports.

• Analyze and summarize, as well as distribute financial reports for respective PI(s) on quarterly basis.

• Manages financial, personnel, planning, compliance and other administrative aspects of research project(s); ensure enough funding to support any proposed, new positions before initiating job posting approvals/requests for posting.

• Oversees activities related to data collection and analysis.

• Coordinates the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

• Protects patient and data confidentiality by ensuring security of research data and personal health information.

• Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.

• Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.

• Understands the federal research regulations and identifies the federal research organizations\' role in regulating human research participation.

• Identifies and explains responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

• Supervises both researchers and research support staff.

• Works collaboratively with PI(s) to provide guidance on potential clinical trials and have full understanding on the resource needs of the projects (i.e. personnel, lab supplies, patient payment for study participation, if applicable, etc.).

• Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.

• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Master\'s degree.

Experience:

• Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, creating monitoring plans).
• Experience with site visits to maintain site certification based on foundation guidelines (Cystic Fibrosis Foundation, Pulmonary Fibrosis Foundation, etc.).
• Supervisory skills.
• Working knowledge of managing research projects.
• Background in a leadership role.

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP).

Preferred Competen