Regulatory Coordinator

at Loyola University Chicago in Chicago, Illinois, United States

Job Description

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· Communicates with the CCTO study teams and disease programs distributing new NCTN study activations, closures, termination, amendments and safety reports, etc.

· Processes IRB , submissions to include but not limited to annual reviews and Adverse Event Reports.

· Communicates with. NCI , CTSU , COG and all NCTN Network Groups regarding protocol activations and overall protocol management.

· Tracks all IRB submissions completed by the Cancer Clinical Trials Office and prepare productivity reports.

· Maintains protocols and protocol documents on the CCTO website which includes data entry in Velos, CTMS database.

· Conducts internal regulatory audits and prepare regulatory files for NCTN Network Group and COG audits as needed.

· Submits Drug Safety list reports to the IRB .

· Participates in the development of standardized processes within the CCTO as it relates to general regulatory compliance.

· Provides training for new staff with regard to clinical trial regulatory affairs.

· Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA , GCP , and ICH Guidelines.

· Serve as primary contact with sponsors, and regulatory agencies.

· Participate in monitor visits and regulatory audits.

· Establish and maintain research project’s regulatory files

· Ongoing communication with the local IRB , federal organizations, affiliate institutions and pharmaceutical study sponsors.

· Participates in Cooperative Group Audits, FDA , Sponsor GCP quality audits, Loyola internal audits and department audits.

· Performs related duties as assigned.

Minimum Education:

Required: Bachelors Degree OR equivalent training acquired via work experience or education

Preferred: Bachelors Degree

Specify Degree(s): Bachelor of Science

Minimum Experience:

Required: Less than one year of previous job-related experience

Preferred: 1-2 years of previous job-related experience

Details: Clinical trials experience

· Bachelor of Science or equivalent degree required; multiple years of clinical trial regulatory experience may be considered in combination with education in lieu of bachelor’s degree.

· Clinical Trials Regulatory experience is preferred.

· Experience in working with clinical trials and/or oncology population preferred.

· Knowledge of medical terminology.

· Ability to communicate effectively. Excellent written and verbal communication skills.

· Ability to function independently and manage assignments.

· Ability to maintain accuracy and consistency.

· Ability to organize workflow.

· Ability to finish tasks in a timely manner.

· Ability to work as an effective team member.

· Ability to facilitate work of others.

· Must have project management skills.

· Computer skills necessary for working with databases and electronic data submission. Familiarity with web-based platforms: accessing information, obtaining necessary documents, access information regarding study groups and federal rules/regulations.

· SOCRA certification desirable

Proficient in Microsoft Office suite.

REDcap proficiency preferred

Computer skills necessary for working with databases and electronic data submission. Familiarity with web-based platforms: accessing information, obtaining necessary documents, access information regarding study groups and federal rules/regulations.