Manager, Research Site - RN Preferred

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
• Assist with tracking of protocol training and ensure documentation of training

KPA 2 - Support and Manage Research Site Operations

• Support interdepartmental meetings and document 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 develop action plans to address performance gaps
• Assess the organizational processes associated with trial execution and identify 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
• 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
• Work at any Company location to help meet the Company's business needs and work overtime when given sufficient notice

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.

Core Capabilities

• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills; 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
• Communication Skills: Good command of the English language; effective communication skills (oral, written, presentation), 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
• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development; self-motivated and self-starter with ability to work independently with limited supervision
• 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