Clinical Coordinator - Anderlecht, België - Pfizer

Pfizer

Geverifieerd bedrijf

Anderlecht, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health.

We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people.

We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

The Pfizer Clinical Research Unit (PCRU) in Brussels (Anderlecht) is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 studies).

Working at the PCRU means that you will contribute to the development of medicines and vaccines that bring real benefit to patients.

You will be an actor in the challenges that the world is facing, in full compliance with quality and safety standards.

Visit PCRU page:

The Clinical Coordinator is a member of the Pfizer Clinical Research Unit which is a global organization with Clinical Research Units in New Haven in the USA and Brussels in Belgium.

On each site the Clinical Coordinator's team is composed of 5 members: 1 Clinical Coordinator Manager and 4 Clinical Coordinators.

The current position is for the Brussels site.

The Clinical Coordinator develops and sustains the operational excellence and quality delivery by managing the operations of clinical part of the studies from study set-up until last contact with participants, the study specific training delivery for the clinical staff and the monitoring of clinical data daily in accordance with scientific, medical and ethical principles and with regulatory requirements guidelines.

Upon enrollment of participants, the Clinical Coordinator is responsible for contacts with participants to ensure the successful execution of the study protocol, any safety assessment required by the principal investigator and ensures good communication.

The Clinical Coordinator provides inputs to and actively participates in internal and external projects.

Main responsibilities- Reviews, interprets, and provides input on study protocol, IP manual (Investigational Product Manual) and DAI (Dosage Administration Instructions), if available, for an optimal clinical study execution.

Provides feasibility assessments on the ability to perform protocol requirements and procedures/ may review ICD ( Informed Consent Document)- Ensures electronic data capture system set-up is built in accordance with field feasibility for clinical staff and protocol requirements- Decides on study specific requirements needed to meet the study objectives & endpoints as specific material ordering- Creation, validation and management of specific procedures and guidance related to specific assessments and/or specific dosing as infusions, injections, - As core contributor provides leadership, supervision, and implementation of study specific trainings to clinical staff upon protocols requirements; occasionally liaise with Pharmacist and Laboratory Project Coordinator for specific procedures required aiming for collaborative training- Performs regular Data Quality Reviews for meeting deadlines and achieving audit-readiness- Communicates with participants and updates required data capture until LSLV

About you- Minimum of a bachelor's degree in Nursing- Minimum of 3 years of relevant work experience in pharmaceutical or medical research (Prior experience in Phase 1 or exploratory research is advantageous), preferably in Training/ Project coordination and/or a quality-oriented position- English (B2) and Dutch and/or French (C1)- Experience indelivering professional trainings & other scientific educational presentationsTraining and project coordination capabilities to meet/exceed deliverab- Computer proficiency including Microsoft Office literacy (Word, Excel, Powerpoint )- Self-driven with high degree of ethics and integrity, performing activities in accordance to Good Clinical Practices (GCP) & other regulatory standards

What do we offer?

Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions.

As a Pfizer colleague, you'll have the opportunity to maximize the impact of medicines for patients in a variety of ways.

In short, you make a real difference.

Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Dutch organization.

There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.

A culture where you can be yourself We are a large, international organization with people from all over the world.

At Pfizer everyone should be able to be