Clinical Trial Support - Business Services Administrator

* Bachelor’s degree in applicable fields or equivalent combination of education and experience* 6 years of experience in clinical trials, research, or compliance roles, including regulatory support, business/research operations, confidentiality and clinical trial agreements, cost coverage analyses, and handling grants, contracts, budgets, and billing.* Public speaking, presentation, analytical, negotiating, and collaborative skills to interact effectively with a broad spectrum of constituents, including faculty members, students, high-level administrators, IRB staff and sponsor representatives.* Comprehensive understanding of research contracts, clinical trial costs, coverage analysis, and data management.* Knowledge of electronic submission systems, and/or databases used to maintain all information pertinent to human research protections.* Ability to multitask and collaborate effectively with others, while also independently managing a wide range of assignments.**Clinical Trial Support Services-** Develops, implements and manages post approval monitoring programs, quality improvement programs, educational and outreach programs, clinical trial support services or other specialized programs as needed. Programs and materials are related to human subjects research in accordance with TAMU, federal, accreditation, and state policies and procedures. Develops and implements institution-wide outreach plan aimed at enhancing the understanding of human research including running clinical trials by investigators, participants and the research community. Drafts, reviews, and negotiates agreements and sponsored research contracts, non-disclosure agreements and associated amendments. Assesses feasibility of industry and investigator initiated clinical trials or clinical investigations. Assists with billing, budgeting, and coverage analysis associated with clinical trials. Assists with regulatory submissions. Identifies learning needs within the research community and coordinates, plans, develops, and implements regulatory training activities including seminars, presentations, and electronic communications. Maintains up-to-date information, templates and other materials. Provides advanced training to investigators, other offices, and staff. Assists investigators and staff as needed with protocols and regulatory requirements. Assists with quality improvement activities. Assists IRB with training and education regarding clinical trial regulatory updates and requirements. Ensures efficient and customer-friendly responses to requests for assistance with clinical trial regulatory process. Under direction maintains and updates SOPs and ensures processes are followed. Schedules remote or in-person consultations, reviewing regulatory records, and preparing reports for investigators or relevant administrative or committee review. Assist with site visits to ensure compliance with applicable regulations. Verifies that concerns or deficiencies identified in regulatory inspections are addressed in a timely manner. Assists with any corrective action plans as needed. Maintains databases and prepares and distributes reports on training and compliance activities. May assist with the supervision, training, and evaluation of the work of other staff and/or student workers. Stays abreast of research compliance best practices and all applicable institutional guidelines and federal regulations.* This position is security sensitive* This position requires compliance with state and federal laws/codes and Texas A&M University System/TAMU policies, regulations, rules and procedures* All tasks and job responsibilities must be performed safely without injury to self or others in compliance with System and University safety requirements* **Hybrid work option** – Due to the nature of this position, a hybrid work arrangement **may** be available for workplace flexibility.Howdy and thank you for your interest in a career with Texas A&M University. As the flagship campus of The Texas A&M University System, we are located in College Station, Texas with a student population of more than 74,000 and nearly 14,000 faculty and staff.

The Spirit of Aggieland is unmistakable. We are a unique American institution, fostering a culture of friendliness, compassion and respect for one another. Our unique history and rich traditions make Texas A&M special.

From our benefits package and professional development opportunities to our retirement programs, Texas A&M is a great place to work. Your path to a great career starts here!

Equal Opportunity/Veterans/Disability Employer.If you need assistance in applying for this job, please contact (979) 845-5154.**Useful Links:** #J-18808-Ljbffr