Study Start Up Specialist

Shared Services: Clinical Trial Center- (Full-Time, Day Shift) - Job Summary: The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310.10). Coordinates the startup process of clinical research studies submitted to the Clinical Trial Center by reviewing study protocols and related regulatory documents in order to assist with feasibility determination, billing plan creation, complete coverage analyses and study startup kit completion. Is responsible for establishing research records in electronic medical record system. Performs other duties as needed. Education and Experience: Bachelor's Degree in a health-related discipline required. Minimum two years of experience in clinical research required. One year of experience with HCPCS/CPT coding preferred. Experience may be accepted in lieu of degree. Knowledge and Skills: Understanding of FDA and Medicare regulations related to clinical trials. Ability to interpret research contracts, study budgets and clinical protocols and consent forms to extrapolate billing/coverage data. Able to use a computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint). Operate/troubleshoot basic office equipment required for the position. Able to work calmly and respond courteously when under pressure; collaborate and accept direction. Able to think critically; manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solve; recall information with accuracy; pay close attention to detail; work independently with minimal supervision. Able to distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position. Licensures and Certifications: None. Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness. Loma Linda University Health is a Seventh-day Adventist, faith and values based Christian institution. Candidates must understand and embrace the mission, purpose, and identity of Loma Linda and its affiliated entities. We are an equal opportunity employer committed to the principles of diversity. We provide equal opportunities in all aspects of the employment process to every individual, regardless of gender, race, color, age, national origin, ancestry, physical or mental disability, marital or veteran status, genetic information or any other characteristic protected by law. In addition, we will provide reasonable accommodations for otherwise qualified individuals requesting an accommodation due to a disability. If you need accommodation assistance with accessing our job listings or completing an application, or during any other phase of employment with us, please contact Human Resources Management at (909) 651-4001. Loma Linda University Shared Services is a religiously-qualified Equal Opportunity Employer under Title VII of Civil Rights Act of 1964. No question on this application is asked for the purpose of unlawfully limiting or excluding any applicant’s consideration for employment because of race, color, religion, gender, age, national origin, disability, genetic information, or any other status protected by applicable law. If you need a reasonable accommodation in the hiring process, please notify Human Resource Management. We appreciate your interest in Loma Linda and wish you success in your job search!