Manager, Research Site - RN Preferred

American Oncology Network•Indianapolis, IN

12h

About The Position

The Research Site Manager is responsible for managing day-to-day site activities, optimizing site performance, and driving the site toward company goals. The manager works with AON leaders to resolve issues that could interfere with those goals and represents the site in a professional, ethical, and positive manner. The role maintains working knowledge of assigned protocols to support patient eligibility verification and valid clinical research data. It works closely with the physician principal investigator, clinical trial sponsors, and study teams, while supporting company financial goals through responsible staffing and purchasing. The manager leads clinical trial implementation and site operations, oversees research coordinators and clinical research pharmacy operations, and supports regulatory submissions, data quality, inspection readiness, financial workflows, and process improvement. The position also develops and supervises site staff, maintains confidentiality and compliance, and may work at other company locations, travel to satellite offices or meetings, work remotely as needed, and work overtime with sufficient notice.

Requirements

At least 2 years of experience in healthcare and research.
Knowledge of FDA regulatory requirements, federal, state, and local regulations, and IRB requirements and submissions.
Oncology clinical trials experience.
Prior leadership and/or management experience.
Professional writing and communication skills for interacting with physicians, monitors, and sponsors.
Valid state driver’s license for travel to satellite offices, clinics, and offsite meetings.
Critical thinking, problem-solving, analysis, decision-making, planning, time-management, and organizational skills; attention to detail and ability to exercise independent judgment.
Interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness; ability to handle sensitive and confidential material and emotionally charged matters.
Good command of English and effective oral, written, and presentation communication skills; ability to listen actively and provide balanced feedback.
Strong customer focus and ability to support quality, performance effectiveness, operational excellence, collaboration, and positive employee, physician, and community relations.
Ability to manage time, competing priorities, stress, and professional development; work independently with limited supervision and work remotely effectively as required.
Ability to work in a fast-paced, multi-site environment and manage competing priorities and stakeholder demands.
Ability to lead discussions and projects, coach, mentor, motivate, and engage others toward shared goals.
Human resources management capabilities, including hiring, coaching, staff development, resource and performance management, employee relations, and supervision within established policies, procedures, and legislation.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Nice To Haves

Bachelor’s degree in biological science, healthcare, or another related field preferred.
CCRC or CCRP certification preferred.
Resourcefulness and heightened analytical abilities preferred.
A second language is an asset but is not required.
RN preference is indicated in the job title.

Responsibilities

Plan and manage clinical trial processes, including multiple trials, daily activities, sponsor deadlines, and trial completion.
Communicate with internal team members, external sponsors, and customers in written and oral form.
Oversee trial site logistics, including site selection, enrollment monitoring, data retrieval, and scheduling site start-up activities.
Supervise clinical research coordinators responsible for screening, enrollment, and patient care during investigational therapy on approved trials.
Assist coordinators with SIV checklists, source document creation, and pharmacy-log review.
Identify enrollment obstacles and communicate them to the Principal Investigator/DOR and study sponsor.
Ensure high-quality clinical data collection and submission in accordance with federal regulations and research protocols.
Create study-specific source documentation tools.
Supervise clinical research pharmacy operations and investigational drug supply at research sites.
Supervise site-level regulatory submissions, including initial IRB submissions, continuing reports, protocol and consent amendments, addendums, and adverse-event reporting; collaborate with study team members maintaining regulatory files.
Track protocol training and ensure training is documented.
Support interdepartmental meetings and document meeting notes and attendance.
Assist with FDA inspection readiness and inspections, and support reporting and corrective action plans resulting from inspections.
Review and respond to monitoring and auditing findings and escalate issues as appropriate.
Assess clinical-trial data quality and performance, develop action plans for performance gaps, and identify process improvements.
Support implementation of process-improvement initiatives and oversee research staff activities for accuracy, completeness, and compliance with federal and state guidelines.
Manage, develop, coach, and motivate clinical site team members to support professional standards and project targets.
Support initial budget negotiations and amendments in alignment with CMS rules, and ensure research financial reporting and collections workflows are followed.
Comply with laws and regulations concerning patient care, patient rights, safety, billing, human resources, and collections, as well as company and departmental policies and procedures.
Maintain orderly work areas and records, maintain company equipment safely and in working order, and protect patient and employee confidentiality in accordance with HIPAA.
Assist with training new employees in related job duties.
Work at any company location as business needs require, travel to satellite offices and offsite meetings, and work overtime when given sufficient notice.