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Academic Programs

Drexel University College of Medicine

Master’s/Certificate Programs in Clinical Research Organization and Management

On-Line

Start Date: Rolling admissions for fall, spring, and summer semesters

Length of Course/Program: 36 credits for MS; 15 credits for Certificate of Study; 9 credits for Quantitative Principles of Clinical Research

Course Description: Drexel’s Clinical Research Organization and Management program (CROM) was created to meet the educational and professional needs of individuals employed or conducting investigations in the complex and highly regulated field of therapeutic product investigation. No residency requirement or on-site classes are mandated. Courses are conducted in such a manner as to maximize the opportunities for learning, both from student to student as well as from a highly experienced faculty, comprising outstanding teachers - researchers, administrators, lawyers, and scientists from academia and industry.

Program Goals: The Clinical Research Organization and Management Program (CROM) Master’s program at Drexel University College of Medicine focuses on formal training in research administration and development, with emphasis on pharmaceuticals, biologics, and medical devices. This program allows students to earn the experience and knowledge necessary to conduct investigations in the increasingly complex and highly regulated clinical field, and introduces students to timely and contemporary industry-related issues. The Clinical Research for Health Professionals (CRHP) Master’s program is designed for those pursuing careers as independent investigators. The curriculum is 5 online courses plus 7 courses devoted to an independent research project. The Certificate of Study program offers an optional professional credential to students who successfully complete five graduate-level courses. The Quantitative Principles certificate consists of three courses – epidemiology, biostatistics, and scientific writing.

Who would benefit from enrolling: These programs are designed to meet the professional needs of individuals employed or conducting investigations in the field. The programs are conducted through a highly interactive eLearning system and are fully accessible to working professionals including study coordinators, study monitors, data managers, project managers, physicians, physician assistants, nurses, and others working in the field. It is also an excellent program for students with a strong science, mathematical or managerial background looking to enter the clinical research field.

Eligibility/Admissions Criteria: Bachelor’s degree from an accredited college or university, or its equivalent from another country. Please see the drexel.com web site for complete admissions information.

Fees: Tuition is $1,005 per credit; discounts on tuition may be available.

Application Deadline: July 10 for Fall; December 5 for Spring; April 11 for Summer

Web address: http://drexel.com/cr

University of Southern California

USC Regulatory Science Programs - MS in Regulatory Science

Los Angeles (onsite & distance learning)

Start Date: Fall, Spring, & Summer terms

Length of Course/Program: Depends on full-time or part-time enrollment

Program Goals: MS in Regulatory Science

Who would benefit from enrolling: Individuals already working in the regulatory science industry and those interested in entering a career in regulatory affairs, drug development and related industries – working at either at a clinical site, government agency or medical products company

Eligibility Criteria: Undergraduate Degree with 3.0 GPA and GRE

Fees: Tuition per unit

Priority Application Deadline: February 1 for Fall, June 1 for Spring, October 1 for Summer

Final Application Deadline: June 1 for Fall, October 1 for Spring, February 1 for Summer

What does this entail? The MS degrees are intensive, interdisciplinary programs designed to produce graduates whose backgrounds in biological, pharmaceutical and biomedical sciences are enhanced by the knowledge and skills needed to manage regulated biomedical products.

For more information:

Contact Name: Laura Sturza, Program Specialist

Address: 1540 Alcazar Street, CHP-140, Los Angeles, CA 90089

Phone: (323) 442-3102

E-Mail: regsci@usc.edu

University of Southern California

USC Regulatory Science Programs - MS in Management of Drug Development

Los Angeles (onsite & distance learning)

Start Date: Fall, Spring, & Summer terms

Length of Course/Program: Depends on full-time or part-time enrollment

Program Goals: MS in Management of Drug Development

Who would benefit from enrolling: Individuals already working in the regulatory science industry and those interested in entering a career in regulatory affairs, drug development and related industries – working at either at a clinical site, government agency or medical products company

Eligibility Criteria: Undergraduate Degree with 3.0 GPA and GRE

Fees: Tuition per unit

Priority Application Deadline: February 1 for Fall, June 1 for Spring, October 1 for Summer

Final Application Deadline: June 1 for Fall, October 1 for Spring, February 1 for Summer

What does this entail? The MS degrees are intensive, interdisciplinary programs designed to produce graduates whose backgrounds in biological, pharmaceutical and biomedical sciences are enhanced by the knowledge and skills needed to manage regulated biomedical products.

For more information:

Contact Name: Laura Sturza, Program Specialist

Address: 1540 Alcazar Street, CHP-140, Los Angeles, CA 90089

Phone: (323) 442-3102

E-Mail: regsci@usc.edu

University of Southern California

USC Regulatory Science Programs - Certificate Programs

Los Angeles (onsite & distance learning)

Start Date: Fall, Spring, & Summer terms

Length of Course/Program: Depends on full-time or part-time enrollment

Program Goals: Five Certificates including Clinical Research Design and Management; Food Safety, Patient Product Safety, Preclinical Drug Development, Regulatory and Clinical Affairs

Who would benefit from enrolling: Individuals already working in the regulatory science industry and those interested in entering a career in regulatory affairs, drug development and related industries – working at either at a clinical site, government agency or medical products company

Eligibility Criteria: Undergraduate Degree with 3.0 GPA

Fees: Tuition per unit

Priority Application Deadline: February 1 for Fall, June 1 for Spring, October 1 for Summer

Final Application Deadline: June 1 for Fall, October 1 for Spring, February 1 for Summer

What does this entail? The graduate certificates are each designed to strengthen skills and tools for those working in the sectors relevant to the certificate.

For more information:

Contact Name: Laura Sturza, Program Specialist

Address: 1540 Alcazar Street, CHP-140, Los Angeles, CA 90089

Phone: (323) 442-3102

E-Mail: regsci@usc.edu

Boston College

Essentials of Initiating Clinical Research

Chestnut Hill, MA

Start Date: March 8

Length of Course/Program: 5 Saturday Sessions, 9 am -3:30 pm

Course Description: Essentials of Initiating Clinical Research

Program Goals: Provide nurses and other professionals with a thorough understanding of the clinical research process, as well as to provide them with the information and tools necessary to assume the responsibilities of an entry-level Clinical Research Associate or Clinical Research Coordinator position. Summarize the clinical research and drug and medical device development processes and recognize basic research methods and their role in clinical research protocols. Describe roles and responsibilities of clinical research personnel and clinical trial service providers. Define the evolution and role of human subject protections and Good Clinical Practice (GCP). Summarize Institutional Review Board roles and responsibilities, informed consent processes, privacy issues, and HIPAA's influence on research. Describe best practices for initiating, conducting, and terminating clinical trials. Describe goals and strategies for subject recruitment and retention, study drug compliance and accountability, and study close-out procedures. Describe processes for monitoring safety, defining, and reporting unanticipated problems and adverse events. Describe quality assurance/improvement systems in clinical research. Describe the role of data management systems in clinical research. Recognize key components of budgeting, evaluating and negotiating contracts in clinical research.

Who would benefit from enrolling: Aspiring Clinical Research Coordinators and Clinical Research Associates - In-house or Field-based, College Students and New Graduates in a Scientific Field, Nurses, Current CRAs or CRCs with less than 6 months experience.

Program Accredidation: Continuing Education Credits

Eligibility/Admissions Criteria: None

Fees: $1899

Application Deadline: March 6

Web address: For application materials and instructions, go to: http://www.bc.edu/content/bc/schools/son/ce/clinical_research.html

San Jose State University

Master of Science in Medical Product Development & Management

San Jose, CA

Start Date: Fall Semesters Yearly - Classes start in August

Length of Course/Program: 35 units / 2 Year full-time; Part-time attendance allowed

Course Description: Managing the complex development of drugs, devices, diagnostics and biologics

Who would benefit from enrolling: Graduates of this program are employed in Clinical Trials Management, Clinical Data Management, Project Management, Regulatory Affairs, Drug Safety, Quality Systems Mgmt, and other positions in the biomedical product development field.

Program Accredidation: WASC

Career Services: Available for students through Program and SJSU Career Center

Eligibility/Admissions Criteria: http://www.medproddev.sjsu.edu/admission-requirements.html

Fees: http://www.sjsu.edu/pdp/programs/mpdm/

Application Deadline: April 1: International and May 31: Domestic Applicants

Web address: For application materials and instructions, go to: http://www.medproddev.sjsu.edu/how-to-apply.html

Contact Name: Tonja Green, Program Director

Address: SJSU / College of Science MZ 0099
One Washington Square San Jose, CA 95192-0099