Academic Institute

To be competitive you need to develop your knowledge base with professional training and work experience. We are looking for individuals with transferable skills who are interested in career transitions to the field of research administration to participate in the HDHC program. HDHC combines online coursework, professional networking, and mentored experiences to efficiently prepare interns to successfully compete for job opportunities in clinical and translational research administration.

The Houston Methodist HDHC internship prepares you for the following job types and more in nonprofit and for profit organizations to perform research. These positions have defined ladders to more senior positions within the organization as your experience, knowledge, and skills grow:

 

• Responsible Conduct of Research Analyst
• Conflict of Interest Analyst
• Institutional Review Board Analyst
• Institutional Animal Care and Use Analyst
• Coverage Analyst
• Budget Analyst
• Research Charge Review Analyst
• Regulatory Affairs Specialist

The application and preparation process takes about 4 weeks. This is followed by a work-study internship for 3 months in the heart of the Texas Medical Center campus. Depending on the rotation, you may be working on-site or remotely.

Interns will spend twelve weeks of the program competing their didactic training and rotating through the offices shadowing working research administrators and completing hand-on projects in offices of Research Regulatory Oversight, Research Integrity and Compliance, Clinical Research Finance and Regulatory Affairs and Clinical Trials.

Where you can complete your internship and which rotations you will do depend upon availability when you apply.

Module	Learning Objectives
Didactic training (online)	Supports all learning objectives of internship. Can be started before your internship begins and must be completed by the completion of the internship.
Regulatory Oversight rotation	List and explain the purpose of the regulations that govern human, animal and biosafety research Understand the roles and responsibilities of the regulatory committees who are responsible for research review and oversight Describe the day-to-day regulatory and administrative support responsibilities of a regulatory analyst
Integrity and Compliance rotation	Describe how a researcher must behave as a responsible member of society, a steward of high-quality data, and maintains the highest ethical standards in the conduct of research Describe the job functions of an Analyst and how they ensure research integrity and compliance Give examples of the types of noncompliance or research misconduct and how they are prevented, addressed, and mitigated. Demonstrate proficiency in use of online systems used to check for signs of research noncompliance or misconduct prior to submitting a grant funding proposal or scholarly manuscript.
Regulatory Affairs rotation	List and describe the purpose of the regulatory requirements for FDA approval of an investigational new drug or device (IND or IDE) List and define the steps of the regulatory pathway for investigational drugs, devices and biologics Describe the process for submission to these regulatory pathways
Clinical Research Finance rotation	Understand the importance of Medicare Coverage Analysis & it uses List and define the steps of conceptualizing, starting, running, and finishing and clinical research study budget Understand clinical research study budget development & negotiations Understand the organization’s revenue cycle and the impact of clinical research Identify and explain the purpose of the regulations governing overall financial and billing compliance

 

All applicants must be at least 18 years of age by the application date and qualify as unemployed or underemployed according to the Texas Workforce Commission Wagner Peyser Grant program. 

• Bachelor’s degree
• Commitment to complete the program and seek employment in research administration
• Attention to detail and strong organizational and time-management skills
• Strong writing skills and ability to communicate effectively and professionally
• Ability to read and synthesize complex information
• Ability to work both independently and as part of a team
• Proficiency in Microsoft Word and Excel
• Transferable skills from other sectors preferred: business administration, financial/billing management, compliance, regulatory, occupational health and safety, legal/paralegal services, communications, education, law, science, health professions or administration.

Start dates available in October, January and May.

Apply

 

Contact:
C. Kim Morris
Bay Area Houston Advanced Technology Consortium
kim@bayareahouston.com

If selected, BayTech will provide:

1. Career Preparation that includes guidance on professional communications with stakeholders, resume and social media development, and interview skills
2. Pre-Internship Transition support that includes matching you with the best internship opportunity based on your assessment, guiding individual development plan (IDP) creation, and supporting you through onboarding and throughout the internship process.

The internship program will cover the cost of training and membership fees for a professional association relevant to your internship to provide access to coursework, networking and job search resources. Parking will be provided during the days you are on-site for your internship. In addition, you will receive a stipend for the duration of your internship. Below are examples of the membership and didactic training benefits.

One-year professional membership for professional networking, education, and job search resources in a society relevant to your area of interest and training:

• Society of Clinical Research Associates (SOCRA)
• Association of Clinical Research Professionals (ACRP)
• Public Responsibility in Medicine and Research (PRIM&R)
• American Medical Writers Association (AMWA)

Preparation Coursework to be selected from:

• ACRP Ethics and Human Subject Protection: A Comprehensive Introduction
• PRIM&R Ethical Research Oversight Course
• PRIM&R Animal Research Oversight Course (AROC)
• CITI Responsible Conduct of Research Basic Series
• CITI Conflict of Interest- Public Health Service Basic Series
• CITI Foreign Corrupt Practices Act for Academic and Research Settings Series
• CITI Good Clinical Practices (GCP) for Clinical Trials Series
• Clinical Research Finance Training Series
• Responsible Conduct of Research

 

Certification

• Good Clinical Practice (GCP) Series and Certification: Certification given with minimum score of 80%, valid for 3 years; coursework administered by the National Drug Abuse Treatment Clinical Trials Network Training

This program is highly competitive and there is a waiting list. Accepting an offer to join the program indicates your intention to seek employment in the field of research administration and a commitment to complete the full program on time and with the highest degree of professionalism. You are responsible for setting realistic but aspirational goals to complete all the self-paced required coursework as early in the program as possible but no later than the last day of the internship. You are also responsible for using the professional membership subscription to further your individual learning and networking goals in pursuit of your career objectives.

Consistent failure to meet the required time commitment, or poor performance of assigned duties, will result in dismissal from the program.