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 escalate 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.

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