CERTIFICATE PROGRAM

The post-baccalaureate Certificate in Clinical Research educates students in the conduct of clinical (human) research studies and trials. The certificate focuses upon foundational knowledge and skills necessary to understand: basic clinical research and trial study design, statistics and data management; ethical principles to respect and protect the rights and welfare of individuals participating in clinical research; and select regulations and guidelines to guide activities related to new biopharmaceutical and medical device product development. 

Students will develop the essential knowledge and understanding to organize, coordinate and administer clinical research studies and trials by working with participants in a culturally-aware manner, supporting and performing quality data collection and applying ethical, regulatory and compliance requirements. Students who complete the certificate will be well-prepared as effective and successful members of the clinical research workforce.

THIS PROGRAM IS NOT ELIGIBLE FOR THE ISSUANCE OF STUDENT IMMIGRATION DOCUMENTS.

Certificate at a Glance

The curriculum requires 12 credits beyond the bachelor’s degree: nine required credit hours focusing on federal clinical research regulations, basic principles of clinical trial design and data management, ethical conduct of research and multicultural communication skills, as well as three elective credit hours from a set of predetermined courses. 

Students are expected to obtain a minimum grade of B in all courses to demonstrate competency in the course areas at the level of a certificate program. Courses may be taken in any order (not all courses are offered every semester), and no prerequisites are required other than those listed in the admission requirement section. All classes follow the VCU Academic Calendar.

Course

Title

Credit Hours

Required courses

BIOS  571

Clinical Trials

3

CCTR 520

Fundamentals of Research Regulation

2

OVPR 601

Scientific Integrity

1

WRLD 302

Communicating Across Cultures

3

Electives

Students must select 3 credits from the following course(s).

ALHP 410

Professional and Clinical Ethics

3

CCTR 640

Team Science: Theories and Practice

2

EPID  580

Public Health Ethics

1

HADE 646

Health Care Organization and Leadership

3

SBHD 605

Introduction to Social and Behavioral Health

3

SBHD 608

Health Communication

3

Student Learning Outcomes

  • Students will demonstrate a comprehensive understanding of and commitment to the protection of the human research participant rights, safety and welfare.
  • Students will commit to practicing as a clinical research professional in an ethical and responsible manner in accordance with good clinical practice and applicable regulations and laws.
  • Students will understand how to conduct clinical research with cultural awareness utilizing appropriate study design and best practices for data collection methods.
  • Students will demonstrate their commitment to engage in continuing education toward becoming increasingly proficient in their practice and to ensure that their practice-related knowledge and skills remain current.

Admission Requirements

THIS PROGRAM IS NOT ELIGIBLE FOR THE ISSUANCE OF STUDENT IMMIGRATION DOCUMENTS.

Applicants to the post-baccalaureate Certificate in Clinical Research must apply online

It is expected that students will complete the program within two years, taking three credits per semester, which also provides adequate time for course offerings which may not occur each semester. The certificate must be completed within three years. 

All post-baccalaureate Certificate in Clinical Research applicants must:

  • Submit a completed application and pay the application fee.
  • Have earned an undergraduate degree — preferably in a life science, a healthcare discipline, a social/behavioral science or mathematics/statistics — from a U.S. regionally accredited university or college (or its equivalent from a foreign institution based upon a four-year program) with a minimum cumulative 2.5 GPA.
  • Provide three letters of recommendation (at least one from a current or former employer).
  • Provide an official undergraduate transcript(s) from baccalaureate-conferring institution, including final cumulative GPA.
  • Submit a statement of intent, not to exceed 500 words, including:
    • Your career goals and how this certificate program would help you meet them
    • Prior work and life experiences related to your interest for this certificate program
    • Your preparedness to successfully complete the requirements of this certificate program
  • Submit a resume/curriculum vitae (CV) showing a minimum of one year of health-related work experience, as well as all relevant information and professional designations.
  • Provide current certificates of completion for the Collaborative Institutional Training Initiative modules in basic human subjects protection and good clinical practice (either social/behavioral clinical trials or biomedical clinical trials).
  • Provide documentation of health-related work experience. Signed/dated letter(s) on institutional letterhead documenting a minimum of one year health related work experience (e.g., clinical, clinical research, allied health, including laboratory sciences). If required experience spans multiple job positions, include letters from each employer (supervisor or human resources) documenting each position.

Additional Requirements

International students must also submit an official transcript evaluation from a recognized foreign educational credentials evaluation service accredited by the National Association of Credential Evaluation Services or the American Association of Collegiate Registrars and Admissions Officers.

Non-native English speakers must also provide evidence of proficiency in English with one of the following:

  • A test of English as a Foreign Language with a minimum composite score of 100 for the internet-based test or 600 for the paper-based score
  • An International English Language Testing System minimum score of 6.5 on the academic exam

Apply Now

Application Information and Deadlines:

  • Rolling admission 
  • Applications for fall enrollment are due August 1.
  • Applications for spring enrollment are due December 11.
  • Semester-based enrollment number is limited.
  • Applicants are considered on an individual basis.
  • Acceptance is based upon application date, application completeness (all required elements), accuracy, and application review.

 

Program contacts:
Catherine Brown, CCRP, 1 (804) 628-6511crbrown@vcu.edu
Shirley Helm, M.S., CCRP, 1 (804) 628-2942shirley.helm@vcuhealth.org

 

Cite & Submit: UL1TR002649

Publications supported by the Wright Center must cite the CTSA Grant number (UL1TR002649) and comply with the NIH Public Access Policy. We rely on these citations as a critical performance measure when reporting annual productivity to the NIH.

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