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Clinical Trial Management (MS)


Mission Statement

The goal of the Master's program in Clinical Trial Management at York College is to provide students with specialization in clinical trial management. Students who complete the program will be qualified to hold jobs as clinical research professionals, opening the door to industry jobs as clinical investigators, researchers, administrators, consultants, data managers, quality assurance managers, regulatory affairs managers, and educators in clinical trial management.

The Program has Three Primary Objectives:

  1. To expand the students' knowledge of scientific concepts, research design, and analysis of clinical trials

  2. To solidify students' understanding of specialized and general clinical trial regulations

  3. To ensure that students establish strong academic and practical skills of clinical trial operations

Student Learning Outcomes

By the time of graduation, students who complete the Master's Program in Clinical Trial Management should:

  1. Possess the ability to communicate ideas and data in writing, including of scientific concepts and research design of clinical trials (CTM 501, CTM 503, CTM 505, CTM 506, CTM 508, CTM 509, CTM 510, CTM 511, PHS 503, PHS 504, PHS 514).

  2. Become proficient with data management and informatics, associated with clinical trials (CTM 501, CTM 507, CTM 508, CTM 511, CTM 513, CTM 516).

  3. Demonstrate leadership and professionalism (CTM 501, CTM 503, CTM 505, CTM 508, CTM 510, CTM 516).

  4. Understand ethical and participant safety considerations associated with clinical trials (CTM 501, CTM 502, CTM 505, CTM 509, CTM 508, CTM 509, CTM 512, CTM 516, PHS 515).

Program Description

Students in this 18-month graduate program complete a total of 36 credits towards the degree, of which 30 credits are from the common Core Courses and 6 credits from the Elective Courses. Students are able to choose elective courses based on their career goals, such as: Clinical Epidemiology, Global Regulatory Affairs and Medical Writing.

Full time students will be expected to take 12 credits per semester. Courses in regulatory science and marketing strategies related to clinical trials will be offered online during the regular academic terms and the summer and winter sessions as needed. Whenever possible, classes will be offered in the evening, weekend or on single days per week for the benefit of individuals working in the pharmaceutical and biotech industry in the New York metropolitan area.

Clinical Trial Management (MS)

36 credits

Core Courses

30 Credits

CTM501

Introduction to Clinical Research and Clinical Trial Terminology

3

CTM502

Foundations of Regulatory Affairs in a Global Environment

3

CTM503

Clinical Trial Project Management

3

PHS504

Advanced Biostatistics

3

CTM505

Ethical Consideration for Clinical Research

3

CTM506

Clinical Trial Implementation

3

CTM507

Introduction to Medical Writing--Document preparation

3

CTM508

Clinical Trial Data Management

3

CTM509

Drug Safety and Pharmacovigilance

3

CTM510

Clinical Trial Management Capstone Project

3

Elective Courses

6 Credits

CTM511

Clinical Epidemiology

3

CTM512

Global Regulatory Affairs

3

CTM513

Medical Writing: Document Submission

3

CTM514

Medical Writing: Investigational Applications for Drugs, Biologics and Medical Devices

3

CTM515

Medical Writing: Drugs, Biologics and Medical Devices License Applications

3

CTM516

Clinical Trial Quality and Compliance

3

CTM517

SAS Programing

3

PHS503

Advanced Pharmacology

3

PHS514

Advanced Toxicology

3

PHS515

International Regulatory Affairs

3

Admission Requirements

Admission to the Clinical Trial Management (MS) Program will be the responsibility of the program Graduate Admissions Faculty Committee and requirements will be consistent with the general CUNY graduate program application policy:

Applicants to the program are expected to have:

  1. A B.A./B.S. degree or equivalent in any natural science, nursing or related discipline

  2. A minimum cumulative GPA of 3.0 in major science courses (biology, math, biochemistry, chemistry, physics and related subjects) from an accredited college or university

  3. Three letters of recommendation

  4. Demonstrated proficiency in fundamental scientific areas such as calculus, biology, and chemistry. Deficiencies in curricular background may be addressed by requiring appropriate undergraduate courses as determined by the program. Students may need to meet additional course requirements depending on their background, such as undergraduate level Biochemistry, Chemistry or Pharmaceutical Science courses.

Application Process

  1. Submit an application via the online portal

  2. Register your recommenders in our online application system, so they are able to submit their letters electronically.

  3. Mail official transcripts and evaluation reports (if required) to:

CUNY York College
Admissions Office, AC-1B07
94-20 Guy R. Brewer Blvd.
Jamaica, NY 11451

Selection Process

York College Office of Admissions will gather and screen the applications for minimum requirements, initial processing and GPA calculation. Admissions decisions will be made by the Graduate Advisory Committee of the department. In some cases, applicants may be invited for an on-site interview.

The Admission Committee, consisting of the director of the program and faculty members, will review completed applications, which will be evaluated on:

  1. Previous academic performance

  2. The quality of the personal statement including conceptual and writing abilities, understanding of the clinical trial process, and relevance of past training

  3. References

  4. An interview with the Admissions Committee, if required

Student Activities and Internships

Students enrolled in the proposed program will have the opportunity to participate in many enrichment and research activities. These include: a) campus presentations and seminars by students and faculty, b) CUNY-wide presentations and conferences, and c) regional and national conferences and seminars.