HCA, Hospital Corporation of America Manager - Clinical Research Associates - Work From Home in Nashville, Tennessee
Manager - Clinical Research Associates - Work from Home
Sarah Cannon Research Institute (SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
Summary of Key Responsibilities:As a senior team member the Manager, Clinical Research Associates assumes line management responsibilities as well as departmental responsibilities aimed at improving the quality of Sarah Cannon research. The Manager is responsible to ensure that the monitoring process is adhered to throughout the conduct of clinical trials in concert with project management, study teams, and Clinical Research Associates (CRAs). The Manager, Clinical Research Associates is a high-profile role within the department requiring the individual to serve as a knowledge resource for the department as a whole and more specifically in guiding CRA team members in the development and enhancement of his/her skills.
Duties and Responsibilities
Duties include but are not limited to: * Determine and manage clinical monitoring resource needs and establish contingency plans for key resources * Establish, monitor, and track performance metrics and productivity standards for Development Innovations CRAs * Track and compile monthly and project-specific reports for Finance regarding CRA resourcing projections and study visits for reconciliation with respective study budgets * Oversee the CRA new hire process to ensure that CRAs have completed the appropriate training * Educate CRAs regarding Sarah Cannon expense and travel procedures. Work with project teams to ensure CRAs are adequately trained for their respective study responsibilities * Acts as a resource person to troubleshoot problems with investigative sites, investigators, and sponsors * Build and maintain strong sponsor and organizational team relationships for the success of clinical trial management * Support Operations and Development Innovations department heads to ensure that monitoring resources are developed, estimated, and reported accurately and timely * Promote effective teamwork among CRAs and provide ongoing direction and management to develop skills for CRAs * Manage Administrative Coordinator colleagues for the division * Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects * Serve as a point of escalation for resolution of issues * Conduct co-monitoring visits with CRAs to document training, assess individual performance and adherence to Sarah Cannon SOPS, Good Clinical Practice (GCP), and ICH regulations and guidelines, determine training needs, and ensure quality assurance/control of CRA visits * Ensure that all team training requirements are completed in a timely manner * Manage, schedule, and establish agendas for CRA Quarterly meetings. Review/manage travel schedules and project workload for CRAs and other staff, as designated * Review and approve expense reports, time-off requests and timesheets for CRAs and other staff, as designated * Conduct annual performance appraisals for CRAs and other staff, as designated. * Regularly meet with Project Managers and study teams to discuss study needs, resourcing, issues requiring escalation * Assist in the interview and hiring process for CRAs and other colleagues, as designated * Ensure that all technical support issues are handled and resolved appropriately
Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience * Knowledge of scientific, medical, and regulatory terms. * Knowledge of ICH Guidelines, GCP, and CFR Title 21. * Clinical research process knowledge with an understanding of medical terminology * Understanding of basic physiology and pharmacology as it relates to clinical research
Skills:The proficiency to perform a certain task * Excellent English written and oral skills. * Interpersonal, communication, and organizational skills.
Abilities:An underlying, enduring trait useful for performing duties * Ability to lead, mentor and line manage a team of CRAs * Ability to work in a team environment under time and resource pressures * Ability to manage, organizes, and makes decisions. * Ability to multi-task in a fast paced environment * Ability for working independently with minimal supervision * Detail-oriented
_Education:_ Minimum Required:Bachelor's College Degree (4 year program) or equivalent experience Preferred:Bachelor's College Degree (4 year program)
_Experience:_ Minimum Required: * Over 5 years of direct monitoring experience or equivalent experience * At least 3 years of previous CRA experience * At least 2 years of CRA Management experience * Experience working in oncology *Preferred: * * Experience using a Clinical Trial Management System (CTMS) preferred * Six Sigma or process improvement experience * Experience working as a project lead or project manager in the past * Someone who understands how budgets and internal capital work within an organization * Understanding of the drug/device development process, including GLP and GMP principles
*If interested in advancing your career in oncology with a growing leader in the clinical industry please apply today!*
Title: Manager - Clinical Research Associates - Work From Home
Location: Tennessee-Nashville-Sarah Cannon Research Institute Clinical Operations
Requisition ID: 25319-3570