Senior Clinical Research Associate - Remote

1w1 week ago

Worldwide Clinical Trials

RO · Full-time · €45,000 – €65,000

About this role

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. We are Worldwide Clinical Trials, a global team of over 3,500+ experts, bright thinkers, dreamers and doers, changing the way the world experiences CROs. Our mission is to work with passion and purpose every day to improve lives.

As a Senior Clinical Research Associate, manage research activities at sites participating in predominantly registries and non-interventional/observational studies. Involved in all stages from site identification and start-up activities like collecting regulatory documents and negotiating contracts, to training sites, maintenance, and close-down. Conduct study initiation visits while ensuring compliance remotely with informed consent and safety events.

Work alongside brilliant minds across diverse therapeutic areas including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds is ingrained in our culture within a supportive, team-oriented environment. Receive extensive support through regulatory submissions, TMF management, and in-house CRAs for heavy site management needs.

Everyone plays an important role in making a world of difference for patients and caregivers. From hands-on, accessible leaders to cohesive teams, we enable professionals from all backgrounds to succeed. Join a diverse and inclusive environment that promotes collaboration, creativity, and thriving by being yourself.

Requirements

2+ years of experience as a Clinical Research Associate
Experience in Hematology, Oncology and Cardiometabolic (Obesity, T1D/T2D, GLP) is required
4-year university degree or RN/BSN in Nursing
Excellent interpersonal, oral, and written communication skills in English
Superior organizational skills with attention to details
Ability to work with little or no supervision
Proficiency in Microsoft Office, CTMS and EDC Systems

Responsibilities

Manage research activities at sites participating in Worldwide’s clinical research projects, predominantly registries and non-interventional/observational studies
Identify potential sites to participate in the research effort
Perform study start-up activities such as collecting appropriate regulatory documents and supporting negotiation of contracts and budgets
Train sites to collect data properly and report potential safety-related events
Manage site activities during study maintenance
Conduct study initiation visits (SIVs)
Close down research activities at sites once the study has concluded
Ensure compliance with obtaining informed consent, reporting safety-related events, and adhering to regulatory requirements remotely

Benefits

Work alongside brilliant minds across diverse therapeutic areas including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases
Extensive support through regulatory submissions, TMF management, and in-house CRAs
Diverse and inclusive environment promoting collaboration and creativity
Hands-on, accessible leaders and cohesive, supportive teams
Remote site management for most efforts