Graduate Certificate Programs in Clinical Research Management

The Foundations of Clinical Research (FCR) program is rooted in the belief that clinical research training is critical to professional development in health care. Clinical research training not only creates potential independent investigators, but also enables clinicians to advance their careers through a greater understanding of research evidence.

Designed to provide learners with the foundational knowledge and skill sets required to produce high-quality clinical research, our program will lay the fundamental groundwork in epidemiology and biostatistics required for a multifaceted career in clinical research.

The overarching goal of the Foundations of Clinical Research program is to equip the next generation of researchers with the skill sets essential to evaluating evidence, understanding biostatistics, and beginning their clinical research careers. Our aim is to ensure that learners develop a strong foundation in the design, implementation, analysis and interpretation of clinical research studies.

Applying Clinical Research Skills to Glean New Insights from Existing Data Sets.

After completing this program, learners will be able to:.

Develop a research question and formulate a testable hypothesis.

Design and begin to implement a clinical research study.

Cultivate the skills required to present a clinical research study.

Critically evaluate the research findings in medical literature.

Evaluate the ethical principles relevant to clinical research.

Teamwork, Training, and Fully Funded Research Through GCSRT.

During the program, our innovative active learning approach emphasizes the traditional tutorial system with weekly live video tutorials, seminars and symposia anchored by 3 live intense weekend online workshops.

Upon fulfilling the FCR program requirements, you will receive a Certificate of Completion. You also will become an Associate Member of the Harvard Medical School and Harvard University Alumni Associations and will be invited to attend FCR program alumni events throughout the year.

The Foundations of Clinical Research program provides the essential skill sets and fundamental knowledge required to begin or expand your clinical research career. Our scholars build a strong foundation in the fundamentals of clinical research, putting them on the pathway to take advanced courses that hone these skills.

Courses in the Clinical Trials Management and Regulatory Compliance certificate use real-world clinical trials to reinforce your foundational knowledge and accelerate your career in clinical research. They will teach you to:.

Understand the entire clinical trials process from the perspective of both the clinical study site and the sponsor or monitor.

Consider and maintain regulatory compliance practices and the ethical standards of clinical research.

Initiate clinical research studies, apply monitoring methods, and write documents and reports.

The program consists of six core requirements with a flexible sequential course progression.

Students can complete the certificate in as little as nine months to three years.

Class sizes range from ten to twenty students per course.

All online courses begin on a Monday with a full week of self-study activities in Canvas, our learning management system.

When registering for a course, Online self-paced refers to the course beginning and end dates, Online fixed dates refer to synchronous sessions.

Core courses allow students to build the skills and knowledge to initiate clinical research studies, apply monitoring methods, and write documents and reports, while understanding and abiding by FDA regulations and International Conference on Harmonization (ICH) guidelines. Each of the six core courses is required to complete the certificate program.

This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines.

This course provides an of the drug development and clinical trials processes.

The purpose of clinical and pharmaceutical research and development.

Phase I-IV clinical trials and an introduction to the special problems of each phase.

This course introduces basic statistical concepts, such as hypothesis testing, the meaning of P value, and power determination. Other concepts with particular relevance to clinical research design and monitoring-such as the importance of randomization and randomization procedures, stratification, crossover designs, non-randomized concurrent control studies, and the use of historical controls-will also be introduced.

This course covers the process of coordinating and managing a clinical study from the perspective of the study site. The course will focus on the operational, interpersonal, and data-management aspects of the process.

The purpose of this course is to introduce you to the process and procedures of monitoring a clinical trial as a clinical research associate working for a pharmaceutical or device manufacturer (known as the sponsor).

The course is focused on trials conducted under U.S. FDA applications (INDs and IDEs).

This course focuses on advanced strategic, operational, and project management topics in clinical research with an emphasis on increasing efficiency and quality at all levels of the process.

Developing, negotiating, and managing comprehensive clinical trials budgets.

Enroll in the Clinical Trials Management and Regulatory Compliance certificate program at UChicago.

Non-Credit Certificate Program in Clinical Trials Management and.

Global Clinical Research: The Process from Start to Finish.

Master of Science in Threat and Response Management.

The graduate certificate in Clinical Research offers students a solid framework from which to understand clinical research. Understanding clinical trial design, drug development, and regulatory requirements will allow them to manage many facets of the clinical research endeavor, whether developing and implementing clinical research protocols or overseeing GCP, compliance and financial matters at an individual or multi-site level.

Find out Northwestern Clinical Research Certificate.

After successful completion of the Clinical Research certificate, students will be able to:.

Utilize regulatory, risk management and quality systems to assure compliant clinical research environments.

Interpret regulatory requirements and apply them to various roles in clinical research.

Complete the following four courses to earn the certificate:.

CLIN RES 400 Essentials of Initiating Clinical Research.

CLIN RES 403 Clinical Research Design and Methodology.

Review curriculum details while you consider applying to this program. Current students should refer to thecurriculum requirementsin place at time of entry into the program.

The Clinical Research Course Schedule page provides you with detailed information on the program offerings.

A variety of factors are considered when your application is reviewed. Background and experience vary from student to student. For a complete list of requirements, see the Graduate Certificate Admission page.

Tuition costs can vary for each of our programs.

The Graduate Certificate Registration Information page outlines important dates and deadlines as well as the process for adding and dropping courses.

The Advanced Certificate in Clinical Research Management is designed primarily for experienced professionals who already hold an advanced degree in a related health care field or in business, and who need a targeted cluster of courses in clinical research management for career enhancement. Candidates for the advanced certificate aspire toward leadership positions in academic research centers or related private sector organizations, such as the pharmaceutical industry.

Qualified students with University College authorization may take up to six units of Clinical Research Management graduate-level course work on a non-degree basis. application located on our Apply page.

International students are only eligible to apply for non-degree study as a Graduate Student-At-Large if they already hold a visa that permits part-time study. International students holding a B-2 or F-2 visa are only permitted to register for courses that are recreational or avocational. program or any of our advanced certificate programs at this time.

Prospective students are urged to discuss admission and tentative course schedules, including prerequisite courses, with the program coordinator.

Applicants should have a baccalaureate degree from an accredited institution and a minimum overall grade point average of 3.0.

International students interested in the certificate programs must hold a visa that permits part-time study (including F-2 and J-2 visas). Students holding F-1 visas are not eligible for these programs. Students holding a B-2 visa may be eligible if the coursework is recreational or avocational in nature.

The online application is available on our Apply page. Applications are ready for review when all fields on the application form are completed and the required documents have been received.

Non-United States course work transcript verificationIf the transcript you submit for consideration is from a college or university outside the United States, a course by course transcript evaluation is also required. Evaluations will be accepted from World Education Services (WES), Spantran or another member institution of the National Association of Credential Evaluation Services (NACES). For Spantran evaluations, you must use this form.

All international students are required to submit TOEFL iBT or IELTS scores at the time of application. The TOEFL iBT and IELTS may be waived for applicants who, immediately prior to their application for admission, have done both of the following:.

This policy applies to all international students, even those who have earned a degree from a United States college or university.

Letters can be submitted through the online application or mailed by the recommender.

At University College, students can take courses without applying to a degree program. If you are interested in taking a class to get to know University College, to fulfill credits, for professional development, or to follow a passion, the non-degree option is for you.

Courses taken toward the Certificate in Clinical Research Management also may count toward the Master of Science in Clinical Research Management.

All courses must be completed with a minimum overall GPA of 3.0.

RELATED PROGRAMSBachelor Of Science In Clinical Research ManagementMaster Of Science In Clinical Research ManagementCertificate In Clinical Research Management.

The Graduate Certificate in Clinical Research Design and Management (a blended program that allows online participation) provides an ideal training platform for those interested in research at a clinical site or in a medical products company.

The Graduate Certificate in Clinical Research Design and Management program is designed to provide the students with a sound understanding of the organization and conduct of clinical trials. They will be able to explain and compare the types of testing that will be required to introduce a new drug or device onto market, and describe the relationship of statistical design and hypothesis development to the validity of the trial and the formulation of claims.

Well-structured and managed clinical trials are an important cornerstone in the development of medical products. The development and execution of such trials requires a knowledge of scientific principles and statistical methods, complemented by a solid grounding in bioethical principles underlying the protection of human research subjects.

Clinical Research Management provides a learning environment in which students will analyze the current policies and guidelines under which clinical projects are organized and regulated. Designed to strengthen the statistical, research and project management skills of clinical researchers and their associated clinical team members, students will also explore the trends in policy development relating to human research.

Our accredited graduate certificates develop specialists for high-demand areas within the broader field of regulatory and quality science. Programs are structured so working professionals can take one or two courses per term.

Earn your Graduate Certificate in Clinical Research Design and Management online. Request information.

The USC Graduate Certificate in Clinical Research Design and Management requires satisfactory completion of 12 units beyond the baccalaureate degree.

Typically, courses offered by the Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission, a course plan will be developed to fit your needs.

Your career in clinical research design and management starts here. Request information today.

All courses offered by the Regulatory and Quality Sciences can be taken online or in-person. Created for working professionals who wish to further their education but cannot travel to traditional classrooms, online students participate in the same classes as students who attend onsite. Lectures can be viewed in real time or at another time.

See program information site for additional information.

Additional financial aid may be available through the program.

Implementation Science and Community Health Outcomes, Graduate Professional Certificate.

Students who are interested in solving problems in community health, health services, or health policy, may want to supplement their training with the Certificate in Implementation Science and Community Health Outcomes.

Current research investments reflect an emphasis on research that looks for ways to translate what has been learned in controlled settings into positive outcomes in clinical practice and community health. This research requires the ability to:.

Form and manage research partnerships with communities and organizations .

The Certificate in Implementation Science and Community Health Outcomes focuses on the development of these skills.

The certificate addresses a well-documented gap in what should be a continuum between basic health and medical research discoveries and the application of those discoveries in clinical and public health practice. To bridge this gap new discoveries must move beyond efficacy studies to research that tests effectiveness in real-world settings, exploring factors that facilitate or impede positive health outcomes. This research requires engagement among community members, organizations, clinicians and researchers as partners in the research process and draws on a distinct set of skills. This certificate focuses on the development of skills to engage successfully in clinical and community health outcomes research.

Whether a student enrolls in the graduate professional certificate or capstone certificate program will depend on their educational goals. (Course requirements are the same for all.).

Graduate Professional Certificate Prerequisites and Application and Enrollment Procedures.

Graduate and professional students from any discipline are eligible to apply for enrollment in the graduate professional certificate program. To be considered for admission, complete the following application procedures.

See the Graduate School policy on Dissertator Status.

Translational and Outcomes Research in Health and Health Care.

Select one course from each of the following areas:1.

Qualitative Methods Relevant to Implementation Science and Community Outcomes Research.

Research Methods and Research Design in Cultural Anthropology.

Qualitative Research Methods in Education: Field Methods I.

Field Research Designs Methodologies in Educational Administratn.

At least one of the courses must be from outside the student major.

Resources to support clinical, translational and outcomes research.

Video lectures on topics relevant to translational and outcomes research (After you open this page, scroll to the bottom.).

Develop a research question a health concern of an actual community.

Heidi Brown, MD, MS Medicine and Public Health.

Maureen Smith, M.D., MPH, Ph.D. Medicine and Public Health.

Eva Vivian, PharmD, MS, Ph.D. Pharmacy.

Jennifer Weiss, MD, MS Medicine and Public Health.

Douglas Wiegmann, Ph.D., College of Engineering, Industrial and Systems Engineering.

Institute for Clinical and Translational ResearchSchool of Medicine and Public Healthictr.wisc.edu.

Graduate Medical SciencesProgramsClinical ResearchHybrid Graduate Certificate Program in Clinical Research.

Clinical research is the fastest-growing discipline in the burgeoning medical device and pharmaceutical industries. Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success. The Boston University Hybrid Graduate Certificate in Clinical Research, designed and offered by the Boston University School of Medicine, is an opportunity for clinical researchers, health professionals, and those interested in clinical research to gain a critical understanding of the scientific fundamentals of human research. Courses in the curriculum provide an in-depth look at a number of the key elements in clinical investigation, including: trial design and conduct, clinical research regulations, good clinical practices of research, and the critical evaluation of clinical research in the medical literature. The program can be completed in one year, across two semesters. We accept applications for both September and January start dates.

Demonstrate the ability to design a clinical research protocol.

Demonstrate the ability to read and critique the clinical research literature.

Demonstrate the ability to interpret and apply the research regulations and practices that guide good clinical practice in clinical research.

Upon completion, students will have developed essential skills and understanding involving the elements and importance of good clinical research design, implementation, and practices.

Apply a portion of the credits earned toward a Master of Science in Clinical Research (MSCR).

Qualify to sit for the Association of Clinical Research Professionals (ACRP) Clinical Research Coordinator exam.

The Hybrid Certificate program in clinical research consists of four courses:.

GMS CI 675 Designing Clinical Research Studies (fall, 4 cr)or SPH BS 722 Design and Conduct of Clinical Trials (fall and spring, 4 cr).

GMS CI 660 OL Good Clinical Practices in Clinical Research (fall, 4 cr).

GMS CI 790 Seminar in Clinical Investigation (spring, 2 cr).

Dual MS in Medical Sciences and Clinical Research.

Note that this information may change at any time. Read the full terms of use.

A graduate certificate in clinical research from Case Western Reserve University School of Medicine can get you there.

Our flexible, interdisciplinary program combines knowledge of biostatistics, epidemiology, and study design with training in ethical, legal and regulatory issues in patient-oriented research.

Offered in a part-time format, the certificate provides a foundational training in clinical research methods without the need to pursue a full Master of Science program in clinical research.

Earning this certificate will grant you the necessary tools to become a effective, efficient and ethical clinical investigator. With only 11 required credits, the program will take you around three to four semesters to complete, whether you pursue online or in-person options. Our curriculum includes courses such as Introduction to Clinical Research, Introduction to Epidemiology, Research Ethics and Regulation, Statistical Methods, and a CITI Basic course in Protection of Human Research Subjects.

After the completion of our program, you will achieve basic competency in the following areas:.

Sponsored by the National Institutes of Health, our KL2 grant program training provides professional development awards that allow for recently trained physicians to pursue mentored research in the disciplines of clinical and translational investigation.

At Case Western Reserve, this process is facilitated through our Clinical and Translational Science Collaborative, one of 60 academic health centers funded under this consortium nationwide to enhance the training of individuals interested in multidisciplinary clinical research. The CTSC coordinates resources relevant to clinical research at the university and our hospital affiliates, including Cleveland Clinic, MetroHealth Medical Center, University Hospitals Cleveland Medical Center, and the Louis Stokes Cleveland Veterans Medical Center.

Young woman wearing a hijab working in a research laboratory.

Discover the Population and Quantitative Health Sciences.

Official transcripts (for the admissions committee purposes, unofficial transcripts can be used to review your application if you are accepted, the School of Graduate Studies will require official transcripts) and.

A personal statement describing your reasons for seeking clinical research training.

The demand for well-prepared clinical researchers to fulfill roles in academic medical centers, private practice research, contract research organizations and biopharmaceutical companies is growing at an unprecedented rate. Now is the time to break into or expand your career opportunities in the biopharmaceutical and healthcare research industries.

Upon completion of this certificate program, students will be prepared to:.

Research, with a focus on clinical trials of drugs and devices.

Apply bioethical standards to medical development and innovations of complex clinical research studies conducted in the healthcare and biopharmaceutical environment.

Apply quality improvement, project or data management to support and monitor clinical research studies.

The Clinical Research Management certificate includes 12 credits of graduate coursework, is offered 100% online and asynchronously and is designed to be able to be completed in three semesters.

All courses in the Clinical Research Management certificate program are included in our existing Masters of Clinical Research program which allows students the opportunity to explore the content of the degree program prior to applying.

Admission to the certificate program will occur every semester.

Online program availability may vary by state.

The George Washington University online Clinical Research Administration (CRA) certification will prepare you to be a strategic leader who drives success for their health care and research organizations. The 18-credit-hour graduate certificate program will strengthen your career prospects while developing CRA management skills for diverse professional opportunities.

The program requires 18 total credits and can be finished in 18 months.

All credits can be transferred into the MSHS in Clinical Research Administration (CRA) program.

The curriculum for this graduate certificate program offers advanced CRA training to students and requires the completion of 15 credit hours in CRA and a 3-credit-hour elective.

Demonstrate a solid grasp of the clinical, regulatory, and business requirements in the planning and conduct of a clinical trial.

Integrate research design principles with scientific, medical, regulatory, and commercial requirements by creating clinical development plan sections to provide adequate benefit to risk assessments in the development of a new investigational product.

Evaluate the importance of assuring data integrity in a clinical trial and preparing various clinical regulatory documents through professional assignments such as quality checking a clinical study report.

Formulate strategies to address ethical and cultural considerations for effective and compliant domestic or international clinical trial conduct in relation to key areas such as human subjects protection, subject recruitment retention, data integrity, and risk assessment.

The online CRA graduate certificate program is ideal for working clinical research professionals, or those in a related field, who wish to increase their knowledge of drug development, clinical trial conduct, monitoring, and the business, ethical, and legal perspectives of the clinical research industry.

Designed to answer the growing need for clinical research jobs and focusing on strategic leadership in the real world, the online CRA certification program offers diversity when it comes to job outlook. The program will prepare you for some of the highest-level positions within clinical research organizations.

Graduates of this clinical research graduate certificate program are prepared to lead health care organizations in the following roles:.

The CRA graduate certificate program at GW consists of 18 credit hours. Please find the cost per credit hour and total estimated program costs here.

Note: Tuition rates are subject to change and additional fees may vary by program.

As you explore an online program at the George Washington University, our dedicated staff is here to support you.

Payscale (2022 January 26). Average Clinical Data Manager Salary.