Clinical Research Associate

Greiner•Monroe, NC

3d•Onsite

About The Position

This role involves monitoring external and internal clinical performance evaluations and internal clinical trials, including development studies and post-marketing complaints/observations. The Clinical Research Associate will be responsible for preparing and reviewing study documents, conducting site visits, communicating with various stakeholders, maintaining trial master files, training study team members, supporting trial submissions, ensuring data accuracy, and performing trial site feasibilities.

Requirements

University degree in biology, medicine, pharmacy or an equivalent combination of education, training and work experience in clinical trials
At least 2 years of experience as a clinical research associate/ clinical monitor in a CRO/medical device or pharmaceutical company
Good knowledge of current industry practices related to the conduct of clinical trials (ICH-GCP, ISO14155, ISO 20916)
Good knowledge of MDR and IVDR, as well as good understanding of GDPR
Ability to work independently and reliably in a fast-paced and changing environment
Excellent communication skills are a must
Travelling required
Driving license

Nice To Haves

Experience with FDA, ISO regulations and CLSI guidelines an advantage

Responsibilities

Monitoring of external and internal clinical performance evaluations and internal clinical trials (development studies, post-marketing complaints/observations)
Preparation of relevant documents for clinical trials according to project requirements and internal processes
Preparation of study documents (e.g. templates/protocols)
Review of study documents (e.g. templates/protocols)
Performance of site initiations, on-site monitoring, monitoring GBO-lab, remote monitoring and close-out visits
Communication with investigators, opinion leaders, consultants, CRO, suppliers
Filing of documents, TMF maintenance
Training of study team members in accordance with protocol specific requirements and (local) regulations
Support the (international) trials submission to authorities and ethics committees
Ensuring the accuracy, validity and completeness of study data
Trial sites feasibilities