Regulatory Coordinator I-On Site

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The general pay scale for this position at MOH is $58,798-$115,068 per year. The actual hiring rate is dependent on many factors, including but not limited to prior work experience, education, job/position responsibilities, location, work performance, etc.

Under general supervision is responsible for supporting the regulatory team with coordinating the research regulatory and administrative activities of clinical trials for the practice. Coordinates the preparation of regulatory submissions for new and continuing review of clinical trials. Works closely with US Oncology Regulatory and Sponsors in coordination of study start-up and closure procedures. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Job Responsibilities:

• Coordinates Critical Document Collection to facilitate the timely opening of trials at the site.
• Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures. Reviews Investigator files and verifies all regulatory documents are filed in accordance with federal, state, and local regulations.
• Assists with scheduling for monitoring visits, study start up visits, close out visits, and audits as needed. Communicates issues with regulatory documents or procedures to clinical staff, research management, and investigators.
• Assists with preparation of Informed Consent Documents and creates regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions. Coordinates local and central Institutional Review Board submissions.
• Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
• May compile information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
• Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.

• High school diploma or equivalent required; some college coursework or other relevant background preferred
• Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required

Business Experience -

• Experience in Microsoft Office
• Experience working with Sponsor Monitor representatives

Specialized Knowledge/Skills -

• Experience working in clinical research is preferred
• Must have excellent communication skills
• Strong ability to multi-task
• Excellent time management skills
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels
• Must have a high level of attention to detail
• Must be able to work in a fast paced environment

Working Conditions:

Environment (Office, warehouse, etc.) -

• Traditional outpatient clinic/office environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an

oncology/hematology clinic environment.

Physical Requirements (Lifting, standing, etc.) -

• Large percent of time performing computer based work is required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.

(This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)