Lara Spaller

Job Description:

• Manages the day to day activities and overall study compliance at APOLLO domestic and Canadian clinical sites
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties (including physicians and research coordinators).
• Drives local evidence dissemination & awareness.

Accomplishments:

• Project Leader for updating and creating worksheets to ensure accurate and complete data collection for APOLLO
• Project Leader for updating APOLLO Delegation Log and Delegation Completion Guidelines
• Member of the APOLLO Site File Review Team that ensures all site regulatory documents, training records, correspondence are collected and stored in accordance with Part 11/FDA/Health Canada compliance and Medtronic/Study related SOPs
• Member of the Research Coordinator Call Team encharged with quarterly virtual Team Meeting to update sites regarding APOLLO study conduct
• Member of the Research Coordinator Call Team encharged with quarterly virtual Team Meeting to update sites regarding TTVR EFS study conduct
• Member of the M&T Operations Team tasked with developing the training checklist and CRS training for updated M&T study team
• Mentor (Wing Person) for Tricuspid CRS to APOLLO
• Member of the Investigator Meeting Planning Committee

Job Summary:
Ensures compliance of research program and associated research studies. Coordinates the compliant implementation and conduct of human subject research projects by utilizing the nursing process, of medium to high workload and medium to high complexity. Assists with research study design and protocol development.
Accomplishments:
• Team Leader
• Lead Coordinator on 7 studies
• Active Coordinator on all EP studies
• Contributed to successful FDA audit for the Option Trial (highest enroller in the country)
• Ability to complete study start up process (assigned study thru first enrollment) in less than 12 weeks

Job Details and Responsibilities:
• Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements, timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
• Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
• Utilizes the nursing process as a basis for patient care.
• Assesses research subject and completes nursing assessment, documenting findings in research subject records then, notifies physician of abnormal findings.
• Establishes a care plan in collaboration with the research subject, family and research team to coordinate ongoing care.
• Identifies discharge needs and facilitates discharge planning as appropriate.
• Performs telephone triage.
• Performs nursing procedures and treatments as directed by physician or LIP in the treatment and management of patient care.
• Evaluates, initiates and maintains standards of care consistent with CCHS policies and procedures.
• Assists with specialized patient care equipment as required by the clinical research protocol.
• Administers medications and treatments as ordered by a physician or LIP.
• Directs, coordinates and participates in the evaluation and supervision of nursing care provided to research subjects; establishing patient care priorities and delegating nursing activities according to the patient needs and staff qualifications and capabilities.
• Participates in education, research and performance improvement activities.
• Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.
• Assists with preparation for audits and response to audits.
• Maintains professional relationships, including frequent and open effective communication with internal and external constituents.
• Assists with the development of training and educational material for assigned research protocols. Provides and documents education as needed.
• Conducts and documents the informed consent process.
• Assists with research study design, development of research protocol and research project budget development.
• Lead coordinator for several IDE and investigator initiated ablation studies
• Other duties as assigned.

Responsibilities:
• Care of patients peri-TEE/CDV, and peri-temporary pacemaker insertion, peri-electrophysiology study, peri-ablation, and peri-permanent pacemaker/ICD insertion,including PIV insertion, peri-left atrial appendage closure insertion, ability to assist MD during sterile procedure, circulate the case, monitor the case, and arterial/venous sheath removal

Achievements:
• Speaker at the annual EP Lab Conference

• Mentor for new hires

Responsibilities:
• Care of patients peri-cardiac cath/PCI, peri-renal angiogram/stenting, peri-peripheral angiogram/stenting, peri-RHC, peri-CTO, plus current duties listed above
• Care of patients peri-catheter based closure of PFOs/ASDs/VSDs
• Care of patients peri-balloon mitral, tricuspid, and mitral valvuloplasty
• Able to manage care for patients peri-IABP
• Able to circulate during and Impella Insertion
• As a Preceptor-Trained and oriented new RNs to perform the above mentioned job duties
• As Charge Nurse-Organize the day, supervise/help staff with all patient care issues in Cath, EP, and
the Holding Area, as well as assisted management with passing Joint Commission Inspection
• Prepare charts for all inpatient and outpatient cases. This includes checking for an updated H&P,
current lab work/EKG, and any other pertinent information for the procedure
Achievements:
• Chair of the Surgical and Interventional Practice Committee
• Winner of the Cleveland Clinic essay contest