Title: Clinical Research Site Director
Location: Chattanooga, TN - ONSITE
Type: Direct Hire/Full-time
Start Date: ASAP Joule is currently looking for a Site Director for one of our clients in Chattanooga, TN. The Clinical Research Site Director oversees site activities to ensure delivery of site targets as received from senior management. The Clinical Research Site Director provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.
Essential Duties and Responsibilities:
Responsible for site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out
Conducts pre-study site selection visits and assessments
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
Schedules staff to cover subjects' visit needs
Conducts staff reviews
Works to ensure enrollment goals of the study center are being met
Monitors subject visits
Supports the team and investigators in overall conduct of the trials
Follows the established monitoring SOPs both corporate and clinical, as well as protocol for specific monitoring plan
Works with QA/QC program prior to sponsor visit
Oversees employees' work before monitoring
Reviews budgets, including clinical research and physicians' costs
Works with the corporate office to evaluate recruitment plans and study start up
Oversees protocol, regulations, and compliance training; ensures training is up to date
Oversee the site financial performance
Train and develop site staff. Ensure that site team understands and performs according to established KPI
QUALIFICATIONS
Bachelor's degree or equivalent and relevant formal academic experience.
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
5+ years of relevant experience as a clinical research associate or clinical research coordinator is required. Must have experience managing trials.
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
Strong written and verbal communication skills. An ability to consume, absorb, and analyze large amounts of information.
Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
Strong computer skills in appropriate software and related company clinical systems are required
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.