Clinical Trial Support - Business Services Administrator

Texas A&M • College Station, TX

9d • Hybrid

About The Position

The Human Research Protection Program (HRPP) is composed of institutional leaders, research review committees, and agents of Texas A&M University that are responsible for protecting the rights and welfare of participants in research conducted or reviewed by Texas A&M University, including Texas A&M Health and all of its locations, the School of Law, and branch campuses in Galveston. The Senior Research Compliance Administrator, under general direction and in coordination with other offices, has the ability to provide efficient financial analysis and resource management services throughout the life cycle of clinical research. Experience with feasibility assessments, budget development and negotiations, and billing compliance requirements including coverage analysis. With prior work with proposal development, clinical trials administration and related grants, contracts, agreements, negotiations, budgets, or billing.

Requirements

• 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.

Responsibilities

• 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.
• IRB Review - Functions as a regulatory analyst to carry out protocol reviews or pre-reviews, including human subjects determinations, exemption determinations, expedited reviews, full board reviews and limited IRB reviews. Assists with other IRB processes as needed.
• Accreditation and Program Assessment Activities - Assists director with preparation of accreditation materials and in various compliance and program assessment activities as needed including periodic assessment of all outreach activities. Creates reports on HRPP/IRB activities as needed.

Benefits

• Health , dental , vision , life and long-term disability insurance with Texas A&M contributing to employee health and basic life premiums
• 12-15 days of annual paid holidays
• Up to eight hours of paid sick leave and at least eight hours of paid vacation each month
• Automatically enrollment in the Teacher Retirement System of Texas
• Health and Wellness: Free exercise programs and release time
• Professional Development: All employees have access to free LinkedIn Learning training, webinars, and limited financial support to attend conferences, workshops, and more
• Employee Tuition Assistance and Educational Release time for completing a degree while a Texas A&M employee

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level