Clinical Trial Management (MS)
The goal of the Master’s program in Clinical Trial Management at York College will be 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:
- To expand the students’ knowledge of scientific concepts, research design, and analysis of clinical trials
- To solidify students’ understanding of specialized and general clinical trial regulations
- To ensure that students establish strong academic and practical skills of clinical trial operations
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For more Information about the Clinical Trial Management (MS) program please contact Prof. Alexander Birk
Student Learning Outcomes
By the time of graduation, students who complete the Master’s Program in Clinical Trial Management should:
- 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).
- become proficient with data management and informatics, associated with clinical trials (CTM 501, CTM 507, CTM 508, CTM 511, CTM 513, CTM 516).
- demonstrate leadership and professionalism (CTM 501, CTM 503, CTM 505, CTM 508, CTM 510, CTM 516).
- understand ethical & 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).
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.
CTM501 Introduction to Clinical Research and Clinical Trial Terminology
CTM502 FDA Regulation and Code of Federal Regulations Applicable to Clinical Trials
CTM503 Clinical Pharmacology
PHS504 Advanced Biostatistics
CTM505 Ethical Consideration for Clinical Research
CTM506 Clinical Trial Implementation
CTM507 Introduction to Medical Writing
CTM508 Marketing Strategies Related to Clinical Trials
CTM509 Clinical Trial Management Capstone Project
CTM511 Clinical Epidemiology
CTM512 Global Regulatory Affairs
CTM513 Clinical Trial Data Management
CTM514 Medical Writing: Investigational Applications for Drugs, Biologics and Medical devices
CTM515 Medical Writing: Drugs, Biologics and Medical Devices License Applications
CTM516 Drug safety and Pharmacovigilance
PHS503 Advanced Pharmacology
PHS514 Advanced Toxicology
Admission to the M.S. in Clinical Trial Management 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 M.S. program are expected to have a B.A./B.S. degree or equivalent in any natural science, nursing or related discipline and 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. Applicants must have 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.
Applicants must complete an application to the program that includes a personal statement, describing career objectives and preparation for the program, official transcripts from previous academic work, and three letters of recommendation. International applicants, whose first language is not English, must demonstrate proficiency in English by providing official TOEFL scores
To fulfill graduate course prerequisites, undergraduate science students (Chemistry, Biology, Physics or others) who apply to the M.S. program in Clinical Trial and Management.
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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:
- Previous academic performance.
- The quality of the personal statement including conceptual and writing abilities, understanding of the clinical trial process, and relevance of past training.
- 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.