Clinical Trial – Contract Administrator

Clinical Trial Support – Contract Administrator Overview

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 customer service through the drafting, reviewing, and negotiation of complex agreements, sponsored research contracts, non-disclosure agreements and associated amendments related to clinical research; has an understanding of human subjects requirements including AAHRPP standards related to contracts and informed consent documents. Experience with clinical trials administration, feasibility assessments and related proposals, grants, contracts, agreements, negotiations, budgets, or billing.

What You Need To Know

Commensurate with experience, salary range: $114,268 - $

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.

Preferred Qualifications

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

• 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…