HCA, Hospital Corporation of America Clinical Trials Manager in Nashville, Tennessee
*Sarah Cannon *is the research arm of HCA’s global cancer enterprise. 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.
We offer you a generous compensation package including: paid time off, 401k, medical, dental vision and life insurance
Summary of your Key Responsibilities:
You will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. You will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team.
Duties and Responsibilities: Your duties include but are not limited to: * Leads the execution of trials for the research team * Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 days of patient visits * Confirm patient eligibility and discuss discrepancies with nursing staff and physicians * Verify screening procedures are performed within the protocol specified window and enroll approximately 1-2 patients per week * Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record * Planning and tracking of all assigned clinical activity in the lifecycle phases of the startup, interim and close out * Educates Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments * Creates study specific tools for source documentation including eligibility worksheets, screening checklists and intense sampling worksheets capturing vitals, ECGs, blood and tumor sampling * Ensures pharmacist has clinical and drug supplies and interfaces with laboratory staff for lab kits and processing * Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations * Participates in monitor visits monthly, on average, for each trial assigned and reviews source documentation and queries for missing documentation * Maintains case report forms tracking management database and reviews trial data for clinical relevance and answers appropriate queries * Apprises research Investigators, Drug Development Management team, and appropriate research staff of all study specific medical issues for guidance * Assists sponsor and US FDA audit teams and reviews and responds to any monitoring and auditing findings and escalates issues defined by Manager of Study Operations * Archives study documentation and correspondence per company policy * Participates in sponsor meetings when applicable * Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects * Adhere to professional standards and SOPs established for clinical research
You should have: * An understanding of how to analyze clinical trial data. * Knowledge of FDA guidelines and GCP is required. * The ability to work independently in a fast paced environment. * Interpersonal skills, detailed-oriented and meticulous. * Professional writing and communication skills. * Organizational and prioritizing capabilities. * Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel
You should have a high school diploma or GED; Bachelor Degree is preferred.
Your experience should include: * At least one year of experience in healthcare, research or other science related field * At least one year of experience planning and managing clinical trial process
Do you want to be a part of a team working together to fight cancer? We are so excited to speak with you about this phenomenal opportunity. Apply to hear more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job: *Supervisors Team Leaders & Coordinators
Title: Clinical Trials Manager
Location: Tennessee-Nashville-Sarah Cannon Atrium
Requisition ID: 03058-5494