Manager, Research Site - RN Preferred

American Oncology Partners, PA; Indiana; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401k with matching

Paid Time Off

Job summary

The Research Site Manager at AONN American Oncology Network Indiana oversees day-to-day site operations for multiple oncology clinical trials, ensuring data integrity and patient eligibility while working with the physician PI, sponsor, and study team.

The role emphasizes regulatory compliance, budget alignment, and staff development, with potential travel and overtime as needed; the site must meet sponsor deadlines and maintain HIPAA and FDA standards.

Qualifications

• Bachelor’s degree in Biological Science, Healthcare or related field preferred.
• CCRC/CCRP certification preferred; valid state Driver’s License for travel.
• 2 years experience in healthcare/research; knowledge of FDA regulatory requirements; oncology trials; leadership experience.

Responsibilities

• Lead the implementation of clinical trials, manage daily site activities and meet sponsor deadlines.
• Oversee regulatory submissions, data quality, and interactions with IRB, investigators and sponsors.

Skills

Leadership

Regulatory knowledge

Data analysis

Communication

Problem solving

Time management

Education

Bachelor's degree in Biological Science, Healthcare or related field

Tools

MS Office

Regulatory software

Job description

Location: Hematology Oncology of Indiana Hiring Range: Job Description Summary:

The Research Site Manager is responsible for effectively managing day-to-day site activities for optimization of site performance. The Site Manager is responsible for driving the site to achieve company goals. It is the responsibility of the Site Manager to work with AON Leaders to problem solve issues that may arise that interfere with achieving company goals. It is imperative to represent himself/herself and the site in the most professional, ethical, and positive manner. This position will maintain an excellent working knowledge of assigned protocols to ensure the validity of the clinical research data and to verify patient eligibility. This position will work closely with the physician principal investigator, clinical trial sponsor, and the study team. Support the financial goals of the company by being fiscally responsible in all areas, including staffing and purchasing.

Key Performance Areas:

• KPA 1 - Lead the implementation of trials for the research department. Plan and manage the clinical trial process understand and analyze data and see through the completion of multiple clinical trials. Organize daily activities effectively and meet sponsor (clinical trial) deadlines. Communicate effectively in written or oral form to both internal team members and external sponsors or customers. Oversee all site logistics related to the trial (site selection, enrollment monitoring, and data retrieval). Schedule site start-up for appropriate team members Supervise clinical research coordinator team who manage the screening, enrollment, and clinical care of patients while receiving investigational therapy on approved clinical trials Assist coordinator to ensure SIV checklist occurs, source documents are created, and pharmacy logs are reviewed Identify enrollment obstacles and communicate them to the Principal Investigator/DOR and the study sponsor. Ensure the collection of high quality clinical data and the submission of clinical data according to federal regulations and research protocols Create study-specific tools for research department source documentation. Supervise successful operations of each clinical research pharmacy which provide investigational drug supply to all research investigator site and patients Supervise site level regulatory submissions, including the preparation of regulatory documents for submission to the Institutional Review Board (IRB) including 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 who maintain regulatory files in accordance with institutional, state and federal regulations Assists with tracking of protocol training and ensure documentation of training.

• KPA 2 – Support and Manage Research Site Operations Supports interdepartmental meetings and documents meeting notes and attendance Assist in inspection readiness of federal agencies (FDA), support inspections when they occur, and any reporting and implementation of subsequent corrective action plans that may result from inspections. Review and respond to any monitoring/auditing findings and elevate issues as appropriate. Assess quality of data and performance of clinical trials and develops action plans to address performance gaps Assess the organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures. Support implementation of process improvement initiatives. Oversee clinical trial-related activities completed/performed by the research staff to ensure completeness and accuracy as well as adherence to federal and state guidelines Manage, develop, coach, and motivate clinical site team members to develop their skills to ensure that a high professional standard is achieved, and project targets are met. Support process of initial budget negotiations and budget amendments in alliance with CMS rules. Ensure processes for research financial reporting, collections system operational workflows are followed Comply with all Federal and State laws and regulations pertaining to patient care, patients’ rights safety, billing, human resources and collections. Adhere to all Company and departmental policies and procedures, including IT policies and procedures and Disaster Recovery Plan. Keeps work area and records in a neat and orderly manner. Maintains all company equipment in a safe and working manner. Maintain and ensure the confidentiality of all patient and employee information at all times as required by the HIPAA regulations. Assist in training new employees to related job duties. Will be expected to work at any Company location to help meet the Company’s business needs. Will be expected to work overtime when given sufficient notice of required overtime.

Position Qualifications/Requirements

• Education: Bachelors’ degree in Biological Science, Healthcare or other related field preferred
• Certifications/Licenses: CCRC/CCRP Certification preferred Valid state Driver’s License for travel to satellite offices and offsite meetings.
• Previous Experience: 2 years experience in healthcare and research. Knowledge of FDA regulatory requirements is required; Federal, State, and Local Regulations, IRB requirements and submissions. Oncology clinical trials experience required. Prior Leadership and/or Management experience required. Must be an energetic, self-starter, and problem solver. Professional writing and communication skills for interaction with physicians, monitors and sponsors are required. Resourceful person with heightened analytical abilities is preferred. Some travel required. Valid Driver’s License for travel to clinics.

Core Capabilities

• 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.
• Leadership and Mentoring: Effectively lead and facilitate group discussions, coach, mentor, motivate, and engage others to align to a common goal. Ability to effectively lead projects from inception through implementation and assessment.
• Human Resources Management: Effectively hire, coach and support staff develop, as applicable, as well as manage resources, performance and employee relations, and supervise within established policies, procedures and legislation.
• Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required.

#AONN American Oncology Network AON is an alliance of physicians and veteran healthcare leaders dedicated to ensuring the long-term success and viability of oncology diagnosis and treatment in community-based settings. It is the fastest growing national network of community oncology practices delivering local access to exceptional cancer care. AON serves its expanding network of partner practices by providing proven practice management expertise. Our employees across the country work together to empower physicians to make cancer care better. By driving integrated, collaborative care, we are proudly helping community oncologists deliver the highest quality care to every patient. Cancer touches everyone. Being able to make a difference in the lives of those fighting this disease is something our employees at AON cherish and never take for granted. A career in oncology offers all sorts of rewards. But working at AON offers employees more than most. As a fast-growing national company, the opportunity to join a national workforce with flexible work options is available. We offer competitive compensation packages that include comprehensive health insurance with a robust provider network. Our 401k, which offers a 100% match and investment options, is available to full-time and part-time staff members, and we feature a generous Paid Time Off (PTO) program. At AON, we offer you more than a job, we offer you a career. As a network of independent oncology practices working together as one, we host annual summits each year, providing our employees a chance to collaborate with AON peers from across the country. Promoting from within is a priority at AON, and we support our team members continued growth through professional development programs and tuition assistance.