Clinical Trials Center Manager
Overview
Position Title: Clinical Trials Center Manager
Position posting date: 11/26/19
Position start date: ASAP or until filled
Salary/Range: DOE (Depending on Experience)
Status: Full-time (between 40 hours) per/wk.
Work Schedule: Monday – Friday, 7:30 am to 4:00 pm
Service/Division: VMRF CORE Administration
Work Location: VMRF
Job Code: MS 1142
Summary:
Under the direction of the Executive Director/CEO, collaborates with VMRF Core Administration and Principal Investigators to establish and manage the daily operations of the Clinical Trials Center (CTC). Ensures trials are administered consistent with federal and local regulations as well as according to the standard operating procedures of the sponsor and/or Clinical Research Organization. Collaborates with VMRF Leadership to establish and maintain a successful Clinical Trials Center. Collaborates with VMRF Leadership and Principal Investigators to provide supervision of Clinical Trials Center Research Coordinators. Collaborates with VMRF Leadership to contribute to broader organizational goals (SOP development, etc.). Assists in the recruitment of new clinical trials to aid in the successful growth of the Clinical Trials Center.
Responsible for the review of all clinical trials to assess for clarity, thoroughness, logistical feasibility, etc. Aligns potential studies with qualified Principal Investigators. Proactively identifies potential study issues/risks and recommends/implements approved solutions. Monitors and discloses opportunities and challenges, including financial and compliance risk. Assists with the preparation, modification, and review of clinical protocols, informed consents, case report forms, clinical study reports, and other study-related documents in consultation with cross-functional project team members. Participates with Contracts and Grants (C & G) Pre-Award staff in study kick-off meetings and other pre-start up activities as needed. Provides input to C & G in the budget review of clinical trials. Participates with C & G Post-Award staff in the management of financial performance and compliance of active studies to avoid deficits, reviews clinical trials billing grid, ensures timely billing, and monitors accuracy of sponsor payments. Develops and maintains reports on clinical research operations to Executive Director/CEO. Maintains working knowledge of FDA and related regulatory agency requirements and standards as related to the clinical trial industry. Acts as an additional point of contact and communicates with all external and internal stakeholders regarding clinical trials activities. Manages stakeholder communications and relationships with appropriateness and professionalism. May perform the role of liaison between Clinical Trials Center and study sponsors. Serves as Research Coordinator to assigned trials. Performs additional duties as required.
Requirements:
Bachelor’s degree in a related field and 8 years of clinical research experience or an equivalent combination of education and experience. Certification as Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) preferred. Certified by the State of California to perform phlebotomy is preferred. Must have extensive clinical research knowledge and cross-functional understanding of clinical trial methodology. Knowledge of the Veterans Affairs Healthcare System (VAHS) clinical research trial processes procedures is preferred.