Lead Clinical Research Coordinator

PURPOSE AND SCOPE: Assists with clinical trial activity, site profit and loss, subject enrollment strategy, and staffing, potentially at multiple clinical research site locations.

Ensures research studies are conducted according to the protocol and established company policies and procedures as well as all applicable State and Federal regulations under supervision of the Principal Investigator (PI) and direct supervisor.

Responsible for performance of study-specific procedures, collection of patient safety data, investigational product management, accurate data collection, data entry, and other duties as delegated and supervised by the PI and governed by Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
General Administration
· Assists with clinical research staff including but not limited to: interviewing and hiring new staff, training of new and existing staff, staff coverage, and team meetings
· Trains to review or negotiate clinical trial contracts, confidentiality disclosure agreements and other legal documents as needed
· Maintains a state of site level audit-readiness
· Trains to Interpret and recommend changes to operational policies as needed, and establish procedures that positively affect provided services
· Interacts in a positive and productive manner with internal and external customers, particularly in problem resolution
· Supports clinical research staff as needed to ensure research subject safety and quality of data
· Trains to ensure oversight of clinical research staff accurate utilization of the Clinical Trials Management System
· Participates and presents at meetings with internal and external representatives as needed, often leading a cooperative effort among members of a project team
· Collaborates to implement processes and operational policies in selecting methods and techniques for obtaining solutions
· Assists local site manager with quality assurance program following the Working Practice Guideline; may be delegated to train local staff and oversee quality assurance program guidelines.
· Assists SMO managerial team in ensuring execution and implementation on quality, education and training across the SMO sites, assisting with quality oversight of SMO locations as requested.
· Serves as a resource for clinical research staff by maintaining up to date knowledge of medical terminology, clinical research trends, Good Clinical Practice, and other site-specific regulations
· Provides resource planning for physician office and dialysis facility-related research
· Liaises with sponsors, CROs, physician practice members and Frenova Renal Research staff
· Acts as an adviser to subordinate(s) to meet schedules and/or resolve technical problems
· Trains to provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters
· R...