Turning data into evidence
Study Coordinator (Onsite Freiburg im Breisgau, Germany, 50% – 100%)
P95 finds, collects, analyses and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines.
Our vision is to be the world’s favourite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use. We are continuously looking for nice, enthusiastic, and smart people.
P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.
As a member of the site study team, the Study Coordinator liaises between the Principal Investigator, Sub-Investigators, other team members and study participants. The study coordinator works collaboratively with the study sponsors.
The responsibilities for the Study Coordinator include, but are not limited to, the following:
The Study Coordinator works with the site Principal Investigator in the following aspects of study planning:
· Completing site feasibility assessment, including questionnaires and participating in pre-selection visits conducted by Sponsor/ Research Organization
· Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, Site source documentation, case report forms (CRFs) and enrollment logs.
· Preparing ethics application and responding to questions.
· Liaising with the Principal Investigator and Sponsor regarding the management, monitoring of the study.
The Study Coordinator works with the site Principal Investigator in the following aspects of study conduct:
· Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
· Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
· Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms , CVs, etc.).
· Support the Site Principal Investigator with participant screening and recruitment activities, completing any related documentation and communicating updates and results to the study sponsor
· Support the Site Principal Investigator in maintaining compliance with the study approved protocol and conditions of ethics approval
· Collecting study data and entering data into the Case Report Form or study database in a timely manner and in accordance with the study-specific procedure
· Conducting study in accordance with national guidelines and jurisdictional health study policy and procedures
· Maintaining essential documents in the Study Investigator Site File (ISF), making records available for review and providing the necessary copies to the study sponsor
· Responding promptly to reporting and monitoring standards, including adverse events and incidents
· Assistance with notifications and submissions to the Ethical Committee.
The ideal candidate will
· have a Bachelor or Master degree, preferably in science/life sciences,
· have a good understanding of health research projects,
· have a minimum of 2 years experience as a study nurse or clinical research coordinator, ideally within an international context,
· have proficiency in MS Office
· be able to think analytically and have good communication skills,
· be inquisitive and wanting to contribute to the development of an innovative company, and
You must also have these skills
· You are fluent in spoken and written German and English, if you are knowledgeable in other languages, this is an asset.
· You are a team player
· You have a flexible approach to work.
· You are a self-starter, well organised and with attention to detail while keeping a “getting the job done” mentality.
· You are focused on delivering high-quality results on time.
· You are sensitive to cross-cultural differences.
· You have excellent collaboration skills with internal and external stakeholders
What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 100+ staff including epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries.
Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations.
We offer you a part-time position, based onsite in Freiburg im Breisgau, Germany. Travel may be required but will not exceed 25%.
For more information, contact firstname.lastname@example.org
Do you want to join us?
Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, please send your application to email@example.com. Please note that if you do not send your CV to that email address, your CV will not be taken into account.
The call will remain open until the position is filled. Only candidates shortlisted for an interview will be contacted. Your CV is important, but we are specifically looking for the right people for our team. Please write to us about why you would like to join us and how you see yourself contributing to P95.
To apply for this job email your details to firstname.lastname@example.org