• Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints
• Conduct informed consent, maintain privacy, and apply principles of human subject protections at all stages in drug and device development. Describe how historical events with regards to subject protection informed changes in the code of federal regulations and other regulatory documents.
• Plan and implement trial related activities in accordance with regulatory and legislative guidances to ensure safety, efficacy and quality in a clinical trial
• Apply Good Clinical Practice with regards to study conduct and management, safety profile management, and the control and handling of investigational products to national and global trials.
• Construct appropriate communications as they pertain to IRB application, FDA and global regulatory agencies, budget negotiations, and other filing opportunities.
• Explain and interpret the flow of study data through electronic data capture programs, and participate in data correction and queries.
• Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research

• Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization safety management, as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints;
• Utilize the principles of pharmacoepidemiology, pharmacogenomics and other drug safety science to analyze potential safety issues and understand the patient population and the risks in the drug development process
• Summarize the specific drug safety function and processes in line with regulatory and legislative framework that ensures safety and quality though the various phases that must be followed in order for the regulatory authority to approve the marketing authorization for a medical product
• Implement drug safety and pharmacovigilance operations as it relates to US and EMA rules, regulations and initiatives governing both safety reporting (ICSR and aggregate reports) and processing data from clinical trials, and post-marketing environments including CIOMS and ICH guidelines.
• Develop and maintain Pharmacovigilance System Master Files, Safety Management Plans and Safety Data Exchange Agreements across clinical study programs and post marketing activities.
• Identify the data sources, data capture, data assessment (seriousness; labeledness/expectedness and causality), data management practices, database tools and MedDRA dictionary for narrative preparation and analysis of clinical and post-marketing safety data
• Perform risk identification (signal detection) and characterize identified risks, potential risks based on signal analysis to develop a risk management plan
• Analyze data obtained from the different Risk Management Tools such as RMPS and REMS
• Identify and implement the practice of leadership and project management through the role of key drug safety professionals with the drug safety function associated with the conduct of clinical research, product strategy and responding to regulatory authority inquiries.
• Discuss the various elements of communication for a cohesive quality management system including effectively preparing and conducting audits and inspections across the site and sponsor, health authorities and contract research organizations as well as within the site through the understanding of multidisciplinary teamwork skills necessary for collecting and querying safety data in a clinical trial

• Design a clinical and translational stu dy incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
• Apply an understanding of the history of ethical and cultural issues, informed consent, inclusion and exclusion criteria in regard to human subject protection and privacy as well as safety as it relates to the drug development process.
• Implement regulatory and legislative guidances and regulations that ensure safety, efficacy and quality for regulatory authority approval for the marketing authorization for a medical product.
• Identify red flags indicating ADRs may be present.
• Conduct consenting processes across a variety of research participants.
• Identify and explain the specific procedural, financial and regulatory documentation including IRBS, clinical trial agreements, and regulatory inspections of site personnel related to the conduct of a clinical trial.
• Describe how data sets the stage as a critical role in a clinical trial including electronic data capture, the importance of information technology in data collection, capture, management, and queries.
• Identify and implement the project management that are associated with the conduct of clinical research and project strategy
• Develop a patient recruitment plan

It is a 36-credit curriculum which offers a broad and well-rounded foundation for the clinical research professional to assist with clinical drug and device studies. The program offers three areas of specialization:  Clinical Research Management; Drug Safety and Pharmacovigilance; and Academic Clinical Research

This program educates individuals to become Clinical Research Professionals who possess a thorough understanding of drug development.

The CRM program will prepare you to work in various settings, including private practice; cooperative research groups; public and private academic institutions; pharmaceutical, device, and biotechnology companies; Clinical Research Organizations (CROs); Site Management Organizations (SMOs); independent research and development organizations; and organizations otherwise involved in the management of clinical trials.

• Bachelor’s degree or higher with a minimum GPA of 3.0
• Two letters of recommendation.
• Application including a 300-400-word statement acknowledging your short-term and long-term career goals
• Official transcript from highest degree attained
• Resume indicating employment and educational background
• Credential evaluation if attended a university outside the US
• TOEFL exam for individuals who have a foreign degree from countries where English is not the official language

You may apply online through the MS application.

We recommend you contact the program director prior to starting the application process at CRMProgram@shp.rutgers.edu.

Overall, the CRM program is considered hybrid, however, the Clinical Research Management (CRM) and CRM-Drug Safety and Pharmacovigilance tracks are didactic courses taught predominately on-line and asynchronously. The Capstone project (field mentorship) has the option to be remote or in-person. The Academic Clinical Research Management courses are predominately taught online. Two courses require in-person attendance at a clinical research site.

Our tuition is credit based at a rate of $1009 for NJ residents and $1050 for non-NJ residents. There is an initial general service administrative fee of
$50. In addition, the school fees are a program fee, technology fee, and distance/hybrid program fee.  For ACRM track, there is also a criminal
background check application fee.

For Tuition and Fees, please see the Graduate Tuition and Fees table.
(Scroll down to RBHS Tuition and Fee Rates and click on School of Health Professions)

Yes, it is available for Master’s Degree student. Contact the Rutgers Student Financial Aid Office at 973-972-4376 or click here.  

Yes, scholarships are available for master’s degree Students. Contact the Rutgers Student Financial Aid Office or call 973-972-4376 or Rutgers SHP scholarships can be found here. 

A small scholarship (Award of Excellence) is available for a select number of students attending the full-time Academic Clinical Research Management track.

Our didactic courses are supported through a learning management system.  Courses require ongoing participation and interaction with the instructor and other students in the class in a synchronous and asynchronous manner.

This active participation is achieved in many different ways depending on the course.  In general these courses require readings from a textbook, journal articles, or visits to websites.  Online discussions (Discussion Forums) with the instructor and students assist in the interpretation, synthesis, and analysis of the readings, while the written assignments are generally structured to assist in applying the information to one’s practice.  Our courses include video clips, lecture handouts, and video-streaming.  Emphasis is placed on developing a conceptual framework supported by the evidence in the literature.

Our program can help in your preparation for the ACRP or SOCRA certification. Our educational program helps decrease the amount of hours required of verifiable work experience to be eligible to sit for some of the certification exams.

In general, participation in each course entails approximately 10-12 hours of work per week.  This includes time spent reviewing lecture content, participation in discussions, written assignments and assigned readings.  Time spent writing papers and/or studying and taking exams are included in this estimate.

No. Even though this program is considered hybrid, there are no on-campus classroom courses. The majority of the courses are remote. The few courses that require/may have face-to-face time are at the field mentorship location. Therefore, this program is not able to provide any student Visa or (Green Card) support/sponsorship.