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Job Title

Clinical Trial Support – 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 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 - $125,694.80A cover letter and resume are required.Qualifications Required Education

+ Bachelor’s degree in applicable field or equivalent combination of education and experience.

+ Six years of related experience.

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 Special Knowledge, Skills, and Abilities:

+ 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.

Preferred Qualifications

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

Preferred Licenses and Certifications:

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

Responsibilities

+ Operational Duties and Responsibilities- Scheduling 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. Helps develop corrective action plans and ensures deficiencies are corrected. Drafts, reviews, and negotiates agreements and sponsored research contracts, non-disclosure agreements and associated amendments. Assists with billing, budgeting, and coverage analysis associated with clinical trials 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 the IRB staff with investigator needs for additional information and materials related to protocol approval. --------Coordinates investigator quality improvement activities. Assists with IRB New Member Orientation and new IRB staff training and education. 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. Stays abreast of research compliance best practices and all applicable institutional guidelines and federal regulations.

+ 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.

Other Requirements and FactorsREQUIRED

+ 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.

Why Texas A&M University?

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

Instructions to Applicants: Applications received by Texas A&M University must either have all job application data entered or a resume attached. Failure to provide all job application data or a complete resume could result in an invalid submission and a rejected application. We encourage all applicants to upload a resume or use a LinkedIn profile to pre-populate the online application.

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/Veterans/Disability Employer.