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Senior Clinical Research Associate - Northern England - FSP

Parexel International

Uxbridge

On-site

GBP 80,000 - 100,000

Full time

9 days ago

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An established industry player is seeking a Senior Clinical Research Associate to oversee clinical sites across the UK. This role emphasizes the importance of patient well-being, requiring a professional who can effectively monitor and manage clinical trials while ensuring compliance with regulatory guidelines. The ideal candidate will possess a strong background in pharmaceutical or biotech environments, particularly in oncology and hematology trials. This position offers an exciting opportunity to collaborate with investigative sites and contribute to the success of clinical studies. If you are passionate about making a difference in patient care, this role is for you.

At least 3 years of pharmaceutical/biotech experience required.
Prior monitoring experience and oncology/hematology trial experience essential.

Field monitoring and management of clinical sites.
Act as liaison between in-house team, vendors, and clinical sites.
Perform Site Initiation Visits and Interim Monitoring Visits.

Pharmaceutical/Biotech Experience

Oncology/Hematology Clinical Trial Experience

Monitoring Experience

Knowledge of CFR and GCP/ICH Guidelines

Communication Skills

BA/BS or equivalent

Relevant Experience and Training

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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