REGULATORY COORDINATORPosition Number:
University StaffJob Type:
Maywood-Health Sciences CampusDepartment Name:
ONCOLOGY INSTITUTELocation Code:
ONCOLOGY INSTITUTE (06310A)Is this split and/or fully grant funded? :
YesDuties 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.
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.
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:
NoRequired operation of university owned vehicles:
NoDoes this position require direct animal or patient contact? :
04/26/2021Quick Link for Posting: