Research Regulatory Coordinator

American Oncology Network • Fort Wayne, IN

1d • $24 - $42

About The Position

Research Regulatory Coordinator is responsible for collaborating with the PI’s and internal and external members of the clinical research team within scope of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB’s as determined, other internal committees and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to perform these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.

Requirements

• High school education required
• Valid state Driver’s License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
• Prior clinical research experience is preferred but not required.
• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
• Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
• Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
• Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook expected.

Nice To Haves

• Bachelors’ degree in Biological Science, Social Sciences, English, or other related field preferred

Responsibilities

• Creates and maintains central regulatory files in accordance with site SOP.
• Ensure completion, submission and subsequent distribution of IRB approved documents in accordance with site SOP
• Effectively manage monitoring and audit activities according to site SOP
• Performs other duties and projects as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED