Clinical Trial Assistant

Job Description THE POSITION: The Clinical Trial Assistant (CTA) supports clinical trials by maintaining organized files, performing pharmacy technician duties, communicating routinely with trial sites, coordinators, and patients while demonstrating good clinical practices and following standard operating procedures. Clinical trials are designed to test new medications and medical devices for safety and efficacy. Trials are highly regulated and thoroughly monitored, which results in a significant record‑keeping and a compliance burden. ESSENTIAL DUTIES AND RESPONSIBILITIES: Monitor study activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Maintain required records of study activity including case report forms, drug dispensation records, and regulatory forms. Order drugs or devices necessary for study completion. Maintain current knowledge of clinical studies affairs and issues by reviewing scientific literature, participating in continuing education activities, and attending conferences and seminars. Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Organize space for study equipment and supplies. Participate in the development of study protocols including guidelines for administration or data collection procedures. Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data. Identify protocol problems, inform investigators of problems, and assist in problem resolution efforts such as protocol revisions. Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary. All other duties assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. EXPECTATIONS OF THE JOB To understand, organize and archive clinical trial documents, including study protocols, SOP’s, Resource Documents, dispensing and manufacturing records, email correspondence, training materials and other study documents. Maintain current lists of correspondence. Administer clinical trials according to good clinical practices and standard operating procedures. Provide general logistical support for clinical trials by entering subject and study site orders and arranging and confirming deliveries of study medications and supplies. Some travel may be required. An individual in this position must be able to successfully perform the expectations listed above. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: High School Diploma/ GED Prior work experience in healthcare or life sciences; clinical trial experience preferred Meticulous attention to detail and a demonstrated willingness to complete routine administrative tasks Ability to work in a team environment Excellent written and verbal communication skills required Strong skills in MS Office programs i.e. EXCEL, WORD and PowerPoint Current State of Missouri Pharmacy Technician Registration required PREFERRED QUALIFICATIONS: Strong organizational and interpersonal skills PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Equal Opportunity Employer We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at View email address on click.appcast.io. #J-18808-Ljbffr