REGULATORY COORDINATOR

Job description

Job Title:

REGULATORY COORDINATOR

Position Number:

8150118

Job Category:

University Staff

Job Type:

Full-Time

FLSA Status:

Non-Exempt

Campus:

Maywood-Health Sciences Campus

Department Name:

ONCOLOGY INSTITUTE

Location Code:

ONCOLOGY INSTITUTE (06310A)

Is this split and/or fully grant funded? :

Yes

Duties and Responsibilities:

-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.
-Maintains Drug Safety list reports.
-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.
-Orders and processes routine office supplies.
-Performs related duties as assigned.

Minimum Education and/or Work Experience:

Bachelor’s degree with three years of job related experience; or an equivalent combination of training and experience.

Qualifications:

- Ability to follow verbal and written instructions and established procedures.
- Ability to perform basic filing, office procedures and word processing.
- Ability to maintain accuracy and consistency.
- Ability to communicate verbally.
- Ability to finish tasks in a timely manner.
- Ability to maintain confidentiality.
- Ability to compose letters and memorandums.
- Ability to deal calmly and courteously with people.
- Ability to analyze and interpret data.
- Ability to function independently and manage own time and work tasks.
- Ability to work as an effective team member.
- Ability to organize workflow.
- Ability to negotiate, persuade and establish direction.
- Ability to maintain office files and follow standard office procedures.
- Skilled job requiring high level of adaptability & interpersonal skills.
- Ability to interact with internal and external constituents.

Certificates/Credentials/Licenses:

Research experience and SOCRA certification desirable.

Computer Skills:

Proficiency with MS Office Suite, Internet and email applications. Strong verbal and written communication skills.

Supervisory Responsibilities:

No

Required operation of university owned vehicles:

No

Does this position require direct animal or patient contact? :

No

Physical Demands:

None

Working Conditions:

None

Open Date:

04/26/2021

Quick Link for Posting:

https://www.careers.luc.edu/postings/15764

 

 

 

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Job No:
Posted: 4/27/2021
Application Due: 5/6/2021
Work Type: Full Time
Salary: