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Senior Clinical Research Associate - Northern England - FSP

Parexel

United Kingdom

On-site

GBP 60,000 - 80,000

6 days ago

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An established industry player is seeking a Senior Clinical Research Associate to join their dynamic team in northern England. This pivotal role involves field monitoring and management of clinical sites across the UK, ensuring compliance with regulatory standards and guidelines. You will collaborate closely with investigative sites, fostering strong relationships while overseeing all aspects of clinical trials, from initiation to closure. If you are passionate about patient well-being and have a background in clinical research, this opportunity offers a chance to make a meaningful impact in the pharmaceutical and biotech fields.

At least years of pharmaceutical/biotech experience required.
Prior monitoring experience is essential, especially in oncology/hematology.

Act as liaison between in-house team, vendors, and clinical sites.
Monitor and manage clinical sites in compliance with regulations.

Clinical Monitoring

Patient Care

Oncology Clinical Trials

Communication Skills

BA/BS or equivalent

RN or health care professional

Microsoft Office Products

CTMS

EDC

eTMF

Parexel are currently recruiting for a Senior Clinical Research Associate, based in northern England to cover UK sites.

In this role, the Senior Clinical Research Associate is responsible for field monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. This role may provide operational input to clinical study teams as directed.

Some specifics about this advertised role

Act as liaison between the in-house team, vendors, and multiple clinical sites.
Work collaboratively with investigative sites to develop strong, long-term, working relationships.
Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
Assist with start-up activities, including essential document review and collection as requested.
Perform Site Initiation Visits.
Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
Perform Interim Monitoring Visits for assigned studies.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

Here are a few requirements specific to this advertised role.

BA/BS, or equivalent, or relevant experience and training with at least years of pharmaceutical/biotech experience. RN or health care professional preferred.
Prior monitoring experience is required. Oncology/hematology clinical trial experience is essential.
FDA/EMA inspection experience is preferred.
Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.
Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).

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