Clinical Research Support Associate
Leeds
Contract until March 2023
£50.50 per hour (8 hour day, 37 hour week)
OVERALL RESPONSIBILITIES:
On behalf of the Medical Device Group, this associate is responsible, to support the CRA Resource Manager - by coordinating and tracking of monitoring and site management work performed by the monitoring resources.
POSITION DUTIES & RESPONSIBILITIES:
- Support CRA Resource Leader in resource planning and allocation of functionally sourced staff and contractors.
- Assist in tracking of CRA workload and deliverables.
- Supports efforts to ensure efficient use of functional resources to provide efficient and high quality deliverables.
- Provide guidance and advice to Clinical Research Associates on company procedures and regulatory authority requirements.
- Assists in coordination of training of Clinical Research Associates ensuring updates on specific requirements.
- May perform accompanied site visits to assess and ensure quality and efficiency of Clinical Research Associates.
- May perform site monitoring and associated activities as needed to support trial activities within the Medical Device Group.
- Support CRA Resource Manager in the maintenance of quality standards, especially in monitoring and site management activities, using functional sourced staff.
- May participate in project management meetings and provide an overview of monitoring resources quality and workload on a regular basis.
- Provide internal communication of important clinical data and events.
- Facilitate and manage study start-up as directed to ensure responsive and efficient process: site qualification, clinical trial agreements and budget negotiation, IRB/EC submissions and approvals, and site initiation/training
- Develop and maintain good working relationships and communication with investigational sites and vendors
- Participate in departmental initiatives aimed at improving process and efficiency, in particular for the improvement of local process.
- Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
- May be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed.
Functional and Technical Competencies:
Strong skills and demonstrated competencies in the following areas are required:
- Solid knowledge of monitoring and site management processes.
- Knowledge of current clinical regulations, standards and good clinical practices
- Written and Verbal Communications
- Good presentation skills and effectively influencing of others
Leadership Competencies:
- Partner and create strong relationships with key internal and external stakeholders, including EMEA CTM/CTLs across the CoE as well as the resource providers and vendors to create a strong and productive partnership;
- Through efficient use of resources, shape the way clinical monitoring is conducted and resources are utilized;
- Engage in transparent and constructive conversations-
- Ensure all sponsored studies have appropriately qualified site monitors and track their activities to ensure all deliverables are met on time and in compliance to SOPs and regulations
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Performs other related duties as required.
EDUCATION & EXPERIENCE REQUIREMENTS:
- Minimum Bachelors/University degree or equivalent required. 4-6 years of relevant experience (or equivalent) required; Master's with 3 years or. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Requires understanding and application of EMEA regulations and standards applied in clinical areas and medical devices/combination products.
- Clinical/medical background - a plus.
- Requires at least 2 years of monitoring experience (medical device and pharma a plus, CRO monitoring experience - a plus)
Due to the volume of applications, we regret that we can only respond to those meeting our above requirements.
