Clinical Study Coordinator / Study Nurse for Investigator Initiated Trials - Translational Pharmacology Group (m/f/d)

At the University of Bielefeld you will receive a unique opportunity to contribute to the construction of a new working group and thus to the design of a modern human medicine faculty. The Institute of the Faculty of Medicine and the University Hospital OWL of the University of Bielefeld, which was commissioned in the course of construction, was accepted for the winter semester 2021/22. The interdisciplinary working group 'Translational Pharmacology' moves at the interface between theoretical basic research and clinical, patient-oriented research. Our scientific focus is on researching individualized drug therapies for chronic diseases, especially in cardiovascular diseases and inflammatory pain. We want to develop a better understanding of how drugs and therapies work at the molecular level – or do not work. To this end, we investigate mechanisms of variability of drug effects and side effects by means of laboratory experiments and in carefully conducted, primarily science-driven clinical trials on small groups of test subjects or subjects. Patients. You take over the clinical study coordination as a Study Nurse. The job is offered as a full-time job and, if desired, an occupation in part-time can also take place. The following position is to be placed in the OWL Faculty of Medicine: (m/w/d) / Study Nurse (m/w/d) für Investigator Initiated Trials - AG Translationale Pharmakologie Reference number: Tech26019 Start: next possible Full time Remuneration depending on qualification and task transfer up to E10 TV-L fixed-term

Establishment and regulatory management of a study ambulance (25 %) Working with Investigator Initiated Trials in a multidisciplinary team organisational management of the regulatory affairs of the working group including licensing procedures of clinical trials, audits, authorities inspections and monitoring visas Responsibility for study cost calculations and billing (in cooperation with the deanate administration) Aid for third-party funding

content cooperation in the development of study protocols incl. Instructions by scientists, doctors and technical staff in the protocol development and implementation of clinical studies according to international standards, laws and regulations (35 %)

Coordination and implementation of clinical trials (in particular Investigator Initiated Trials) in close cooperation with a multidisciplinary team (30 %) recruitment and support of study professionals Collection of individual parameters to patients (e.g. vital signs, EKG, questionnaires) Extraction, processing and collaboration in laboratory analyses of biological materials and samples Shipping of biological materials and samples documentation and management of study-relevant data; Handling clinical studies Information systems Working with data analysis and the development of publications and research applications

Participation in teaching and training on ''clinical translational research' (5 %)

further administrative activities (5 %) Processing of general correspondence Ordering and procurement of laboratory equipment and materials

We expect completed, relevant university studies (e.g. Bachelor) in Biology, Biochemistry, Molecular Medicine, Human Biology, Pharmacy, Animal or Human Medicine, Health Sciences or comparable suitable courses as an alternative: completed vocational training in a suitable health profession, e.g. as a health and nursing assistant, Med. specialist, Med. documentation assistant*in or comparable training Professional experience in conducting clinical studies independent, independent operation high sense of responsibility and reliability Communication skills, team skills Gender and diversity competence patient-oriented and friendly appearance safe language skills in German (in word and writing) safe knowledge of how to use MS Office Interest in internationally connected, scientific work

We wish certified qualification for the Study Nurse / Student Assistantin / Studies Coordinatorin certified training in Good Clinical Practice Experience in preparing approval procedures for clinical trials Qualification for venous blood withdrawal Computer knowledge (e.g. clinical studies documentation) English language skills in word and writing further language skills in word and writing Risk assessment (IATA)

Remuneration depending on qualification and task transfer up to E10 TV-L limited to 2 years (§ 14 para. 2 TzBfG) Full time internal and external training opportunities Variety of health, consulting and prevention offers Compatibility of family and occupation Possibility of a temporary implementation for employees of Bielefeld University fixed place of service (Bielefeld) without travel flexible working hours FlexWork: basic option for home office (catch depending on the specific task field) good transport connection Additional operational care (VBL) collegial cooperation open and pleasant working atmosphere exciting and varied activities modern working environment with digital processes diverse offers (Mensa, Cafeteria, Restaurants, Uni-Shop, ATMs, etc.)