Job Title

Clinical Trial Support - Business Services Administrator

Agency

Texas A&M University

Department

Research Compliance & Biosafety Programs

Proposed Minimum Salary

$9,522.34 monthly

Job Location

College Station, Texas

Job Type

Staff

Job Description

Our Commitment

Texas A&M University is committed to enriching the learning and working environment by promoting a culture that respects all perspectives, talents & lived experiences. Embracing varying opinions and perspectives strengthens our core values which are: Respect, Excellence, Leadership, Loyalty, Integrity, and Selfless Service.

Who We Are

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.

What We Want

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..

What You Need To Know

Compensation will experience, salary range: $114,268 - $125,694.80

A cover letter and resume are required.

Position Details: Hybrid Work Option: Due to the nature of this position, a hybrid work arrangement may be available for workplace flexibility.

Qualifications

Required Education and Experience

• Bachelor's degree in applicable field or equivalent combination of education and experience.

• Six years of experience in industry or federally supported clinical trials, investigator-initiated clinical research, or within a compliance or administrative group focused on regulatory support, business operations, or research operations. This includes prior work with grants, contracts, agreements, negotiations, budgets, or billing.

Required Knowledge, Skills, and Abilities

• Strong written and verbal communication skills are essential, as well as, 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.

• Ability to work independently with minimal supervision.

• Ability to manage multiple projects (timelines, reviews, deliverables).

• Knowledge of computer use and applications including word processing programs, spreadsheets, and electronic submission systems, and/or databases used to maintain all information pertinent to human research protections.

• Ability to multi-task and work cooperatively with others.

Preferred Qualifications

• Master’s degree in education, business, research, or science related field.

• Any of the following: Certified IRB Professional (CIP), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) Certified Clinical Trials Manager (CTM)

• Knowledge of biomedical and behavioral research including clinical trials in an institution of higher education.

• Ability to provide efficient customer service through the drafting, reviewing, and negotiation of complex agreements and sponsored research contracts, non-disclosure agreements and associated amendments

• Familiarity with granting agencies (government, international, private, industry, etc.).

• Understanding of CPT, ICD-9 and medical terminology

• Working knowledge of billing, budgeting, and coverage analysis

• Knowledge of regulations and ethical principles regarding research including HIPAA, FDA, OHRP and FERPA in addition to above knowledge, skill and abilities.

• Ability to cultivate and maintain professional working relationships with people of varying backgrounds.

Responsibilities

• Development and Management of Post Approval Monitoring Program, Quality Improvement Program, Clinical Trial Support Services and/or Outreach and Education Program: 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.

• Program Development of Clinical Trial Support Services: Drafts, reviews, and negotiates agreements and sponsored research contracts, non-disclosure agreements and associated amendments and coordinates with other offices (e.g. Sponsored Research Services) as required. Assists with billing, budgeting, and coverage analysis associated with clinical trials and coordinates with other offices as required (e.g. Sponsored Research Services). Helps develop corrective action plans and ensures deficiencies are corrected. Identifies learning needs within the research community and coordinates, plans, develops, and implements regulatory training activities including seminars, presentations, newsletters, and electronic communications; Updates and maintains the HRPP website with up-to-date information, templates and other materials. Provides advanced training to investigators, other offices, and staff. Assists with new staff training and education. Stays abreast of research compliance best practices and all applicable institutional guidelines and federal regulations.

• Program Management of Clinical Trial Support Services: Schedules remote or in-person visits, reviewing approved study records, and preparing reports for investigators and relevant review committee. Lead site visits to ensure compliance with approved protocol and applicable regulations. Verifies that concerns or deficiencies noted during inspections, post approval monitoring visits, or quality improvement assessments are addressed in a timely manner. Assists the IRB staff with investigator needs for additional information and materials related to protocol approval. Coordinates investigator quality improvement activities. Ensures efficient and customer-friendly responses to requests for education and outreach activities and materials. Under direction maintains and updates SOPs and ensures processes are followed through periodic review with office procedures. 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.

• IRB Review: Functions as a regulatory analyst or member of the IRB 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.

  Why Texas A&M University?

  Texas A&M University is committed to enriching the learning and working environment by promoting a culture that respects all perspectives, talents & lived experiences. Embracing varying opinions and perspectives strengthens our core values (https://www.tamu.edu/about/coreValues.html) which are: Respect, Excellence, Leadership, Loyalty, Integrity, and Selfless Service.

We are a prestigious university with strong traditions, Core Values, and a community of caring and collaboration.  Amenities associated with a major university, such as sporting and cultural events, state-of-the-art recreation facilities, the Bush Library and Museum, and much more await you.  Experience all that a big city has to offer but with a reasonable cost-of-living and no long commutes. 

• Health (https://www.tamus.edu/business/benefits-administration/medical/) , dental (https://www.tamus.edu/business/benefits-administration/dental/) , vision (https://www.tamus.edu/business/benefits-administration/vision-insurance/) , life and long-term disability insurance (https://www.tamus.edu/business/benefits-administration/life-add/) with Texas A&M contributing to employee health and basic life premiums

• 12-15 days (https://employees.tamu.edu/employee-relations/leave/index.html) of annual paid holidays

• Up to eight hours of paid sick leave (https://employees.tamu.edu/employee-relations/leave/paid/sick.html)  and at least  eight hours of paid vacation each (https://employees.tamu.edu/employee-relations/leave/paid/vacation.html) month

• Automatically enrollment in the Teacher Retirement System of Texas

• Health and Wellness: Free exercise programs and release time (https://flourish.tamu.edu/wellness-release-time/)

• Professional Development: All employees have access to free  LinkedIn Learning (https://linkedinlearning.tamu.edu/)  training, webinars, and limited financial support to attend conferences, workshops, and more

• Employee Tuition Assistance (https://livingwell.tamu.edu/employee-tuition-assistance/) and Educational Release time (https://employees.tamu.edu/employee-relations/leave/paid/educational.html) for completing a degree while a Texas A&M employee

All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution’s verification of credentials and/or other information required by the institution’s procedures, including the completion of the criminal history check.

Equal Opportunity/Affirmative Action/Veterans/Disability Employer.