Lauren Easley Email & Phone Number

Columbus, Oh, Us

Columbus, Oh, Us

Oversees Clinical department activities for SPR clinical research studies. Works along with the Head of Clinical Affairs to accomplish department objectives by managing projects, staff, planning, and evaluating department activities. Interfaces with collaborating clinical sites and internal departments (e.g., R&D, engineering, regulatory, marketing) in the conduct of clinical studies by SPR.• Collaborates with the Head of Clinical Affairs on the strategic direction of the Clinical department. • Works with the Head of Clinical Affairs on study forecasting and resource planning. • Develop and implement clinical processes to support applicable Clinical team members, study operations, staff training, and SPR policies. • Oversees and manages clinical project personnel and/or consultants. Provides supervision and/or guidance to other clinical personnel, including those that are not direct reports.• Responsible for the day-to-day management of clinical trial projects including development of project timelines, study budgets and project management plans. • Responsible for the management of assigned clinical trials including investigator selection, establishment of enrollment and recruitment strategies, and preparation of trial related documentation (protocols, case report forms, consent documents, NDAs, and contracts). • Manages activities performed by consultants, CRO’s and vendors including initial identification of a suitable partner, definition of responsibilities, monitoring milestones and budgets to ensure project success. • Performs personnel related supervisory duties as applicable, including selection, development, and performance evaluations of personnel to ensure the efficient operation of the team. Reviews and approves time and expenses for direct reports.

Oversees and implements clinical study activities for SPR projects. Works along with the Director of Clinical Affairs to accomplish department objectives by managing staff, planning, and evaluating department activities. Interfaces with collaborating clinical researchers and internal engineering and regulatory staff in the conduct of clinical studies by SPR. • Train, manage, and support applicable Clinical team members.• Conduct regular performance assessments and review/approve time and expenses for direct reports. • Collaborates with the Director of Clinical Affairs on the strategic direction of the Clinical department. • Works with the Director of Clinical Affairs on study forecasting and resource planning. • Develop and implement clinical processes to support study operations, staff training, and SPR policies. • Perform activities of Clinical Project Manager as needed, including managing and monitoring clinical studies conducted by SPR Therapeutics to ensure compliance with study protocols, regulatory requirements, grant requirements, and Good Clinical Practices. • Develops project timelines, study protocols, informed consent forms, case report forms, databases, and other study support documentation for studies sponsored by SPR Therapeutics. • Drive site selection and subject recruitment programs that deliver enrollment targets.• Develops and conducts training programs for SPR clinical studies. • Provide formal oversight of sponsor obligations transferred to CRO’s and other providers.• Manage relationships with vendors and consultants to provide adequate support and services of clinical studies.• Develops internal standard operating procedures for the conduct of clinical studies.• Negotiates site budgets and contracts.• Monitor and manage the clinical trial budget according to research contracts. • Prepares regulatory submissions for SPR products and clinical studies, including IDE’s, 510(k)’s, PMA’s, HDE’s, and Annual Reports, as needed.

Coordinates and implements clinical study activities for interventional pain management studies. Interfaces with collaborating clinical researchers in the conduct of clinical studies. Responsibilities include: •Coordinates and manages clinical studies to ensure compliance with study protocols, regulatory requirements, grant requirements, and Good Clinical Practices•Develops study protocols, informed consent forms, case report forms, databases, and other study support documentation for studies. •Drives site selection and subject recruitment programs that deliver enrollment targets.•Prepares/reviews monitoring reports following study site visits.•Provide formal oversight of sponsor obligations transferred to CRO’s and other providers.•Assists sites in preparing IRB submissions and annual reports.•Develops and implements data management methodologies for the conduct of clinical studies.•Trains clinical site staff on study protocols and data management methods.•Plans and conducts Investigator Meetings in conjunction with the Clinical Team.•Prepares regulatory submissions for products and clinical studies, including IDE’s, 510(k)’s, PMA’s, HDE’s, and Annual Reports, as needed.•Assists in clinical support for company products as needed.

Began contract role as Clinical Project Manager for a Sponsor client. Responsibilities include:•Conducting and managing clinical trials (including feasibility, pilot, and pivotal studies)•Assisting in the development of study protocols, study reports, clinical documents, and regulatory submissions•Serving as primary contact with sites for all questions related to eligibility, study conduct and follow-up, data entry, IRB submissions, and technical device questions•Working with third party vendors including a recruitment firm to coordinate and implement recruitment activities, an EDC vendor, and a CRO to coordinate monitoring activities•Serve as study monitor for smaller studies•Mentorship and management of internal CRA and Research Intern

Working for a company that specializes in overall site development: monitoring, auditing, training, and research consulting. Working with sponsoring companies, contract research organizations, and investigators to assist in the device, biologic, and pharmaceutical research processes.Responsibilities include:•Conducting site initiation, periodic site visits, and close out visits and writing reports of findings from site visits •Conducting remote review of electronic data, identifying and following up on discrepancies, and performing on-site source data verification•Assisting sites with regulatory documentation, and ensuring appropriate documents are sent to the sponsor•Identifying and following up on compliance issues•Training research coordinators and physicians on study protocols and federal regulations/requirements related to clinical studies•Providing support and assistance to clinical research sites •Acting as a liaison between sites and the sponsor and CRO

-Coordinate the conduct of research studies including the planning, implementation, and follow through for industry-sponsored clinical trials while following FDA regulations, ICH guidelines and GCP standards. -Responsibilities include recruiting, screening and enrolling participants; obtaining informed consent; collection of clinical research data; dispensing study medication and ensuring accuracy of documentation.