Assistent/Assistentin - klinische Studien

Media sources related to this profession include KKS Netzwerk - Koordinierungszentren für Klinische Studien, MMP Medizinische Monatsschrift für Pharmazeuten, Pharmakon, and PZ Pharmazeutische Zeitung.

A significant trend in this field is the production of customized medicines from 3-D printers. The first tablet produced via 3-D printing has already been approved in the USA, and researchers in Germany are also exploring methods and materials for the pharmaceutical industry. The main advantage lies in the personalization of medicines, where dosage and active ingredient combinations are adapted to patients, leading to the creation of so-called 'polypills'. This production process presents new challenges for pharmaceutical production specialists and those responsible for approval matters.

Assistants for clinical studies primarily work in offices, clinic, or institute rooms. They may also work from home or remotely if necessary.

Core competencies fundamentally required in this profession include drug dispensing, drug testing, office and administrative tasks, data protection, clinical trials (drugs), medical documentation, project assistance, and trial execution and evaluation. Further competencies that may be significant for practicing this profession include drug information, pharmaceutical law, international pharmaceutical standards (e.g., GLP, GMP), clinical research, patient care, pharmacology, quality management, legal knowledge (medical devices), and statistics. Additionally, the competence group 'Office communication, MS-Office' is among the relevant skills and knowledge.

Assistants for clinical studies predominantly work in offices at computers, utilizing databases and specialized software. Together with specialist doctors or scientists, they, for example, create examination forms, conduct studies, and evaluate data. They may also have contact with study participants, for instance, when dispensing medication. Participation in clinical studies requires a very careful and responsible working approach; errors by assistants in entering data into documentation forms can falsify study results. Knowledge of medical and pharmaceutical terminology, as well as proficient English skills, are indispensable. In the approval of medicines, various regulations, legal requirements, and data protection guidelines must be observed. Assistants are typically part of a project management team.

Example gross basic salary in the public service collective bargaining area (monthly): €3,418 to €3,891. Example gross basic salary in the commercial economy sector (monthly): €3,653 to €4,311. Sources: Collective Agreement for the Public Service of the States (TV-L), Collective Bargaining Collection of the Bavarian State Ministry for Family, Labor and Social Affairs. This information is for orientation purposes only and no claims can be derived from it.

This profession is typically found in the pharmaceutical industry, particularly in the production of pharmaceutical specialties and other pharmaceutical products, such as the evaluation of clinical tests within drug trials. It is also common in other research and development in natural sciences, engineering, agricultural sciences, and medicine, especially medical research. Employment is also possible in healthcare settings like university hospitals that conduct studies on the effectiveness of new medications.

Employers often expect candidates to have completed an Ausbildung (vocational training) in the healthcare sector.

Assistants for clinical studies find employment in pharmaceutical companies, at scientific institutes, and in clinics.

The common job title for this profession is Assistent/in - klinische Studien. It is also commonly known as Clinical Trial Assistant (CTA).

Employees in community and medical facilities born after 1970 must provide proof of their measles vaccination or immunity, in accordance with the Infection Protection Act.

Assistants for clinical studies support project teams in medical research with the preparation, execution, and documentation of clinical studies.

Job postings for this profession can be found on various job and applicant exchanges such as Fédération Hospitalière de France, hum-molgen, kliniken.de, md-stellenboerse, Medische Vacaturebank, Springer Medizin, and StaffSanté.fr.

Associations and organizations active in this field include the Professional Association for Health Services and Welfare (BGW), the German Research Foundation (DFG), the German Hospital Association (DKG) e.V., and the United Services Union (ver.di).

This profession typically involves screen work (e.g., maintaining study databases, preparing study-relevant documents, contributing to reports and publications), office work (in offices of pharmaceutical companies or scientific institutes), and teamwork (working with specialists and scientists). Adherence to various regulations and legal requirements for drug approval is essential.

Work materials include documents such as patient evaluation forms, status reports, form letters, documentation sheets, project documents, ethics applications, legal regulations, and data protection guidelines. Data management systems like study databases, medications such as study drugs, and office equipment including PCs, internet access, and telephones are also used.

Assistants for clinical studies perform organizational tasks in project management or clinical monitoring teams. They procure or create and prepare the necessary documents for investigations. They also prepare the investigations themselves. During the conduct of clinical studies, they manage project documents and compile materials for approvals by ethics committees or government authorities, for example. Furthermore, they dispense study medications, support study participants, and contribute to quality control in accordance with Good Clinical Practice (GCP) guidelines.

Access professions include Specialist for Media and Information Services specializing in Medical Documentation, Medical Documentation Assistant, and Pharmaceutical-Technical Assistant.

Continuing education for adaptation helps to keep professional knowledge up-to-date and adapt to new developments (e.g., in the fields of Medical Documentation, Database Programs, Pharmacy, Statistics).

Further professional and career opportunities open up through advanced training for career advancement (e.g., as a Pharmaceutical Representative) or an undergraduate degree (Studium) (e.g., in Nursing Management, -Science, or Pharmacy study programs). Under certain conditions, it is also possible to study without a general higher education entrance qualification. For more information: Access to higher education in the individual Bundesländer (federal states).

Taking on organizational tasks within a project management or clinical monitoring team; procuring and managing documents and data; creating or preparing patient evaluation forms, status reports, or serial letters; maintaining databases; controlling data, e.g., reviewing documentation forms; compiling documents, e.g., for obtaining approvals for clinical studies from ethics committees and government authorities; preparing investigations; controlling, dispensing, and documenting study medications; supporting study participants; participating in the quality control of clinical studies.

The following lists professions or activities that show similarities to the original profession. These professions represent a possible alternative for applicants. Furthermore, employers can consider personnel from these professions as alternatives for filling a position in the original profession. Some alternative professions only include partial activities of the original profession, while others require an induction period, which can vary in length in individual cases. The following immediate employment and staffing alternatives are available for the profession of Assistant for Clinical Studies: Job and staffing alternatives for the overall activity (usually short induction): Medical Documentalist, Medical Documentation Assistant, Study Nurse. In related professions: Secretary in Healthcare. A list of all possible degrees of relatedness can be found here: Explanations of the individual degrees of relatedness.