Job Title: Senior Clinical Research Associate - SCRA - Oxfordshire
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Vacancy details
Vacancy description:
Job Code:
J293788
Job Title:
Senior Clinical Research Associate - SCRA - Oxfordshire
Job Category:
Clinical Research
Contract:
Permanent
Discipline:
CRA, Clinical Study Coordinator, Clinical Study Admin, Clinical Trial Administrator
We are currently seeking an experienced (Senior) Clinical Research Associate who is looking to progress their career and develop more skills. If you are looking for an opportunity to move forward then this is the right opportunity for you! In addition to their very competitve salary, they offer a fantastic benefits package with relocation assistance where appropriate!
Position Summary
Requires minimal direction to assist the Associate Director or Manager in areas of study and project planning and implementation including protocol and case report form preparation, study site evaluation and selection, study initiation, routine study monitoring, study closure and preparation of final study reports and IND annual reports. This position requires a strong knowledge of GCP and/or ICH guidelines, regulatory requirements and quality assurance procedures. In addition this position will assist with establishing and monitoring study progress and updating study timelines. This position requires minimal direction from more senior clinical research personnel to determine methods and procedures on new assignments and to complete project deliverables. This position is responsible for mentoring to Clinical Research Associates I and Clinical Research Assistants.
Job Requirements and Qualifications
Typically requires a BSc in a relevant scientific discipline or equivalent qualification in life sciences, nurses or paramedical discipline plus a minimum of 3-5 years of relevant clinical experience or life science environment in the pharmaceutical industry or equivalent. This position may require 30-50% travel.
Key Roles and Responsibilities
Drafts and provides guidance on the development and amendment of relevant documents including protocols, informed consents, case report forms (CRF), CRF instructions, monitoring plans, abstracts, presentations, manuscripts, clinical study reports, Investigator’s Brochures. Interacts with Investigators in protocol development, presentations and publications. Provides operational support to assist with the management of safety reporting for UK/EU clinical trials.
Independently performs pre-study site visits (PSSV) and selection of sites, site monitoring (initiation and closeouts) visits, source data clarification/resolution of data discrepancies and review of regulatory documents/files. Provides mentorship and guidance to junior team members of the team and may manage outside vendors and external contract clinical research associates (CRA).
Interfaces with senior clinical operations associates to plan, implement and manage overall study deliverables and to ensure adequate cross-functional communication. Responsible for management of the clinical study within the scope of the projected budget.
Prepares interim and final clinical study reports. Prepares clinical responses to quality assurance (QA) data audits.
Coordinates and/or participates in a leadership role in Investigator Meetings, clinical team meetings and ongoing training to internal team and external team (including study coordinators, investigators, vendors regarding OSIP processes).
Assists in contract research organization (CRO)/Vendor/Contract CRA selection and responsible for CRO/Vendor/Contract CRA management.
May participate in project team meetings.
Keywords: Senior Clinical Research Associate SCRA Oxfordshire Permanent
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