Clinical Trial Support - Contract Administrator
Apply NowCompany: Texas A & M University
Location: College Station, TX 77840
Description:
Job Title
Clinical Trial Support - Contract 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 - $125,694.80
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
Preferred Qualifications
Responsibilities
Program Development & Management- Develops and manages the business processes for drafting, reviewing, and negotiating agreements and sponsored research contracts, non-disclosure agreements and associated amendments and coordinates with other offices (e.g. Sponsored Research Services) as required. Identifies and develops templates and SOPs for business processes. Assists with billing, budgeting, and coverage analysis associated with clinical trials and coordinates with other offices as required. Identifies learning needs within the research community and assists with the development of outreach programs related to human subjects research.
Clinical Trial Support Services- Drafts, reviews, and negotiates agreements and contracts. Assists with billing, budgeting, and coverage analysis. Recommends corrective actions as related to regulatory compliance. Provides training to faculty, staff or administrators and assists with updates to HRPP website and other outreach initiatives.
Accreditation & Program Assessment Activities- Assists director with preparation of accreditation materials and with various compliance and program assessment activities including periodic assessment of all outreach activities. Creates reports on clinical research and other human subjects' activities as needed.
IRB Review- Functions as a pre-review regulatory analyst or member of the IRB, as qualified, 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.
Other Requirements and Factors
REQUIRED
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.
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.
Clinical Trial Support - Contract 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 - $125,694.80
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.
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
Program Development & Management- Develops and manages the business processes for drafting, reviewing, and negotiating agreements and sponsored research contracts, non-disclosure agreements and associated amendments and coordinates with other offices (e.g. Sponsored Research Services) as required. Identifies and develops templates and SOPs for business processes. Assists with billing, budgeting, and coverage analysis associated with clinical trials and coordinates with other offices as required. Identifies learning needs within the research community and assists with the development of outreach programs related to human subjects research.
Clinical Trial Support Services- Drafts, reviews, and negotiates agreements and contracts. Assists with billing, budgeting, and coverage analysis. Recommends corrective actions as related to regulatory compliance. Provides training to faculty, staff or administrators and assists with updates to HRPP website and other outreach initiatives.
Accreditation & Program Assessment Activities- Assists director with preparation of accreditation materials and with various compliance and program assessment activities including periodic assessment of all outreach activities. Creates reports on clinical research and other human subjects' activities as needed.
IRB Review- Functions as a pre-review regulatory analyst or member of the IRB, as qualified, 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.
Other Requirements and Factors
REQUIRED
- 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.
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, 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
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.