Clinical Research Associate - Barcelona, España - Qiagen

Qiagen

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare.

We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.

Our most valuable asset are our employees - more than 6000 in over 35 locations around the world.

Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.

There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.

If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

The Clinical Research Associate (CRA) at QIAGEN is an important role within the Clinical Affairs team, serving as a primary contact between the company and study sites and coordinating all correspondence among internal and external study stakeholders.

Key responsibilities:

Where required, participate in the site selection process, perform site initiation and training, interim and close out activities with sites.
Where applicable, work with the study group to coordinate activities with the site in preparation for the initiation of studies including IEC submission, regulatory submissions, contracting and other necessary submissions for site activation.
Coordinate the company resources with sites for instrument setup and IQ/OQ, testing procedure training and test proficiency verification where applicable.
Responsible for forecasting sufficient supply of study materials (reagents, consumables, and files) according to site consumptions. Maintain documents and inventory accountability following company SOPs for all materials.
Ensure timely transmission of clinical data with sites by collecting CRFs or onsite data entry. Review the quality and integrity of the clinical data through onsite SDV and timely solving of data queries. Work with DM on database verifications, database lock and related reviewing process.
Work with CTA on electronic online maintenance of study binders (eTMF) ensuring integrity by timely upload/update/review/approval of documents following SOPs.
Review protocols, eCRFs, study manuals and other related documents, as requested by CSL or other study group members.
Where required, conduct site QC visit or sponsor audit on assigned study if performed by CRO or outsourced CRA, and report back to CSL for quality validity and suggestion of improvement and mitigation plans.

Position Requirements

Previous experience of working in Clinical Research or the Pharmaceutical Industry.
Knowledge of the Industry/Clinical trial process, drug development or medical devices.
Education in scientific or medical field; prior experience in clinical diagnostic or molecular biology research lab preferred.
Experience with diagnostic clinical trials; knowledge of ICH GCP and regulatory requirements for IVD's and working within a regulated environment.
Experience of audit situations.
Experience working and managing external study sites.
Ability to travel 2540% as required.

What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

Job Reference:
EMEA04200