Clinical Research Specialist

작업 내용

Location: Belgium - Office based
Schedule: Full Time, 12 month Fixed Term Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it’s the best of both worlds….

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Research Specialist to join one of our clients, one of the most innovative pharmaceutical company in the world.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:
On behalf of the Medical Device Group, the Clinical Research Specialist is responsible, to support the CRA Resource Manager - by coordinating and tracking of monitoring and site management work performed by the monitoring resources.

Main Job Tasks and Responsibilities:

• Support CRA Resource Leader in resource planning and allocation of functionally sourced staff and contractors
• Assist in tracking of CRA workload and deliverables
• Support 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
• Assist 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
• 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
• 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

Education and Experience:

• 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 4 years of monitoring experience (medical device and pharma a plus, CRO monitoring experience - a plus)

Specific Role Requirements and Skills:

• Solid knowledge of monitoring and site management processes
• Knowledge of current clinical regulations, standards and good clinical practices
• Written and verbal communications skills
• Good presentation skills and effectively influencing of others

The Benefits of Working for TalentSource in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About CROMSOURCE
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Specialist, Medical Devices, Pharmaceutical, Pharma, Temporary, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated

Durata contratto: 12 mesi

Job Types: Full-time, Contract

Schedule:

• Monday to Friday

Education:

• Bachelor’s (Required)

Experience:

• Clinical Research Specialist: 4 years (Required)