CAS Clinical Research II (Clinical Trial Planning and Conduct) Certificate of Advanced Studies
This program is designed to prepare professionals for leadership and strategic roles across diverse clinical research environments, including academia, pharmaceutical and biotech industries, medical device companies, clinical research organizations (CROs), and regulatory authorities.
Advanced Program: Clinical Research Management, Leadership & Innovation
Participants will:
- Develop advanced project management skills tailored to clinical trial planning and execution.
- Explore efficiency strategies and innovative technologies, including the application of Artificial Intelligence (AI) in trial design, patient targeting, and data analysis.
- Gain a deep understanding of the ethical challenges involved in research with human participants.
- Navigate complex international regulatory and legal frameworks in clinical research.
- Strengthen communication and conflict resolution skills essential for leading interdisciplinary teams.
- Learn to apply AI tools specifically within the context of clinical research to improve trial efficiency, data quality, and patient outcomes.
This continuing education program has been designed to meet the needs of experienced clinical research professionals from industry and academia (study/trial coordinators, study /trial managers, study physicians, clinical trial/research associates, clinical monitors, study nurses, etc.), as well as experienced members of ethics committees or regulatory agencies. It provides an opportunity for advancing experience, knowledge and skills and for professional networking in the environment of clinical trial practice and management.
Students interested in a higher level of postgraduate education in this field may consider completion of the program Diploma of Advanced Studies (DAS) Clinical Trial Practice and Management. The DAS program requires successful completion of the CAS Clinical Research I or an equivalent training program from other universities, successful completion of the CAS Clinical Research II, composition of a diploma thesis and passing of an oral final exam
| Course language: | English |
| Duration: | approx. 12 months |
| Next Start: | November 2, 2026 |
| Workload and ECTS: | 120 contact hours (plus additional assignments, pre-readings and online parts), 11 ECTS |
Classroom training dates 2026/2027
- Modul 1, Ethical and Legal Aspects of Clinical Trials: November 4-5, 2026
- Modul 2, Clinical Study Project Management: February, 26–28, 2025
- Modul 3, Advanced Clinical Trial Management: June, 25–27, 2025
- Modul 4, Communication, Collaboration and Partnerships in Clinical Research, September 25–26, 2025
This program consists of four modules. Each module includes:
- Online Training for self-paced learning and individual study.
- Classroom Sessions featuring practical exercises, case studies, and group discussions.
- Assessment through multiple-choice tests to verify acquired competencies.
- Homework Assignments designed to deepen understanding and apply concepts in real-world scenarios.
- Workshadowing 5-days, allowing participants to observe clinical research professionals in practice and reflect on their experience in a written report.
Classroom Training
- Modul 1, Ethical and Legal Aspects of Clinical Trials, 2 days
- Modul 2, Clinical Study Project Management, 3 days
- Modul 3, Advanced Clinical Trial Management, 3 days
- Modul 4, Communication, Collaboration and Partnerships in Clinical Research, 2 days
Online training material will be available approximately one month prior the respective classroom training.
Course certificates will be issued after successful completion of the online module tests, submission of all homework assignments and submission of the work-shadowing report.
This course is open for everyone who already has experience in clinical research and aims to expand their expertise in trial management, leadership, and innovation.
It is especially appropriate for people working in any area of clinical research either in academia or in industry (study nurses, study coordinators, clinical research associates, study physicians, assistant physicians, etc.)
The admission requirements are:
- Completion of the CAS Clinical Research I, the CAS Study Nurse / Coordinator, oran equivalent course from another University.
- Very good command of oral and written English
In exceptional cases, candidates who can demonstrate an adequate professional background and professional qualifications may also be admitted to the degree programme.
Minimum 15 and maximum 40 participants.
Fee CHF 7,000
Reduced course fee DKF research group members (for details see *)
*) The Department of Clinical Research (DKF) offers training grants for members of DKF research groups which result in a reduced fee of CHF 5,500. The reduction will be applied when registering for the program. Please note, that training grants can only be offered to DKF clinical research group members, who are working at the group leaders’ local study center
Fees include course materials, provisions during coffee/tea breaks and overhead fees. The course fee will be collected in two equal tranches approximately 6 months apart.
Cancellation and withdrawal
Cancellations made prior to the closing date for enrolment will not be subject to any charge. If a cancellation is made after the closing date for enrolment, the full applicable fee will be charged. Course fees already paid will not be refunded. Should participants withdraw from the program or discontinue participation, no discount from the course fee will be granted and any share of the course fee will not be refunded.
Director of Studies:
- Dr. Andrea Kiemen
Teaching staff:
- The multidisciplinary teaching faculty consists of national and international experts in clinical research ethics, regulatory sciences and the different fields of operational clinical research.
Mareike Gräter
Training and Education
Department Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel
mareike.graeter@clutterusb.ch
Tel. +41 61 556 59 76
Please register here.
The next course cycle will start in November 2026. If you are interested to participate, please register here and you will be informed about all news and the opening of registration of the next course cycle.
Registration will be open in early summer 2026. Registration deadline is September 3rd, 2026.
Medical Faculty of the University of Basel
For PhD Students: To add this course to your academic record, please create a Learning Contract on MOnA, before the start day of the course and follow the instructions of your respective faculty. Please note, that 3 ECTS can be obtained.
Universitätsspital Basel Hebelstrasse 10, 4031 Basel
Hörsaal 6 (ZG), Markgräflerhof (beim Blutspendezentrum)