Job Title

Clinical Trial Support Senior Compliance Coordinator

Agency

Texas A&M University

Department

Research Compliance & Biosafety Programs

Proposed Minimum Salary

$7,200.26 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 Coordinator, under general supervision, provides advanced protocol review and advises and assists investigators, administrators, and others on the requirements of human subjects research, biomedical or behavioral clinical trials, FDA IND/IDE regulations and single IRB processes. Assists and educates investigators on Good Clinical Practice requirements and investigator responsibilities including regulatory file set-up.

What You Need To Know

Commensurate with experience, salary range: $86,403.12 - $95,043.36

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.

• Four 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, clinical operations, or clinical research.

Required Knowledge, Skills, and Abilities

• Ability to effectively communicate with a broad spectrum of constituents, including faculty members, students, high-level administrators, and IRB staff.

• Knowledge of word processing, spreadsheet, and database applications.

• Ability to multitask and work cooperatively with others. Effective interpersonal and organizational skills.

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.

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

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

Responsibilities

• Protocol Pre-Review and Post-Review Functions: Consults and advises faculty, staff, and students in the preparation and execution of protocols based on thorough knowledge of guidelines, and Federal regulations for human subjects research including clinical trials. Provides advanced pre-review of protocols for compliance including providing recommendations and feedback to supervisor and investigators. Assists investigators with applicable Good Clinical Practice (GCP) and FDA IND/IDE requirements. Performs post-review functions by preparing correspondence, minutes and other reports based upon IRB determinations. Provides support to study teams during clinical trial initiation, close-out, management of investigational products, and internal or external audits.

• HRPP Resources and Contact: Advises and provides expertise about human subjects research to investigators and committee members related to regulatory and institutional guidelines. Responsible for effective communication and timely responses related to research reviews. Responds to questions regarding the HRPP compliance program. Prepares training materials and conducts regulatory training. Assists investigators and other staff with regulatory files, compliance documentation and navigating the electronic IRB system to ensure compliance and mitigate problems in the workflow. Works with supervisor in the development or modification of standard operating procedures (SOPs) and office processes. Performs advanced reviews and contribute to updating SOPs. Creates and runs reports as needed. Serves as primary contact for timely responses related to compliance reviews, including issues of non-compliance. Responds to complex questions regarding the compliance program and clinical trial requirements. Manages coordination with other offices and programs providing ancillary reviews. May train other staff and/or student workers on duties and SOPs.

• Records Management: Provides second level support on monitored document submissions, reports, and notices for quality control, and maintains records. Provides quality assurance oversight of data entry related to research submissions, reports, and notices. Maintains electronic and paper files ensuring all are accurate and complete.

• IRB Meeting Management: Contributes to committee meetings by working collaboratively to solve complex problems and providing job related expertise. Prepares for meetings by organizing review materials, agendas and other meeting related documents. Provides expertise in human subjects research and clinical trials for investigators and committee members in compliance guidance.

  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.