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Pharmaceutical - Clinical Research Associate II (CRA II) Jobs - North West

Pharmaceutical - Clinical Research Associate II (CRA II) Jobs - North West (Job Ref: WR/JOBS/23033-9439)

Job Description :

Job Summary

Flame Health Pharmaceutical – Clinical Research Associate Job – North West:

We urgently require an experienced Clinical Research Associate (CRA) for our client, a global Pharmaceutical Organisation to be responsible for an International Phase III Pain Study, with sites in the North West. This excellent field based role is ideal for an experienced monitor with previous site management experience and will in return provide an excellent opportunity to work for a growing Pharmaceutical company.

Job Title

Clinical Research Associate II (CRA II)

Background

We are looking for candidates to perform trial initiation, monitoring and close out activities in Phase II-III clinical research, managing study site activities to ensure clinical data integrity in line with company and regulatory guidelines.

Key Responsibilities

 
• Performs clinical trial initiation, monitoring and close out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).
• Completes study start-up activities.
• Develops and implements innovative approaches for site selection, and pre-study activities to identify and evaluate potential investigators
• Completes site evaluation and reports to Lead CRA / Clinical Project Manager as appropriate
• Completes submission of documents to the Ethics Committees
• Collects, reviews and tracks regulatory documents when required
• Manage and track investigator grants with study sites when required
• Assists with the development of study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents
• Actively participates in the preparation and coordination of investigator meetings and attends when required.
• Completes pre-study visits with study site staff
• Provides status updates of pre-study and initiation activities to Lead CRA / Clinical Project Manager.
• Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomisation procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures
• Develops patient enrolment strategies with the clinical project team and study sites
• Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with the project plan
• Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials
• Manages study site activities and provides ongoing updates of site status to Lead CRA / Clinical Project Manager
• Maintains tracking records for assigned sites such as tracking of status and source document review per patient

Qualifications and Experience

• BS / BA or equivalent with proven clinical trial monitoring experience or experience as follows: Previously related health care or clinical research experience (e.g. study coordinator) and clinical trial monitoring experience.
• Previous practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company, or CRO preferred.
• Experience or education indicates a sound basic knowledge of medical and pharmaceutical terminology.

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary in the region from £25000.

Key Words

Clinical Research Associate, CRA, Senior Clinical Research Associate, SCRA, North West, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in the North West