Clinical Trial Support Contract Administrator
Clinical Trial Support Contract Administrator
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$ 114268 - 125694
1 Vacancy
Job Description
Job Title
Clinical Trial Support Contract AdministratorAgency
Texas A&M UniversityDepartment
Research Compliance & Biosafety ProgramsProposed Minimum Salary
$9522.34 monthlyJob Location
College Station TexasJob Type
StaffJob 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 nondisclosure 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: $114268 $125694.80
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
Bachelors degree in applicable field or equivalent combination of education and experience.
Six years of experience in industry or federally supported clinical trials investigatorinitiated 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
Masters 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 nondisclosure agreements and associated amendments
Familiarity with granting agencies (government international private industry etc..
Understanding of CPT ICD9 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 institutionwide 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 nondisclosure 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 uptodate 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 inperson 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 customerfriendly 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 prereviews 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 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 stateoftheart 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 costofliving and no long commutes.
Health dental vision life and longterm disability insurance with Texas A&M contributing to employee health and basic life premiums
Up to eight hours of paid sick leaveand at leasteight hours of paid vacationeach month
Automatically enrollment in theTeacher Retirement System of Texas
Health and Wellness: Free exercise programs and release time
Professional Development: All employees have access to freeLinkedIn Learningtraining 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
All positions are securitysensitive. Applicants are subject to a criminal history investigation and employment is contingent upon the institutions verification of credentials and/or other information required by the institutions procedures including the completion of the criminal history check.
Equal Opportunity/Affirmative Action/Veterans/Disability Employer.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
