Lauren Easley Email & Phone Number

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.
• 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.

• 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.
• 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.

• 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.

• 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

• 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.
• 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

-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.