Description:
Location: Belgium - Office based

Schedule: Full-time, Permanent

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 Trial Assistant to join one of our clients, one of the most innovative pharmaceutical companies 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 their client counterparts.

The Clinical Trial Assistant is responsible for processing, tracking, and filing study documents, and management of the Trial Master File (TMF) within the clinical projects. In addition, administratively support clinical study staff as required. Supports project managers within the assigned clinical studies.

Main Job Tasks and Responsibilities:

• Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
• Creation/distribution of regulatory binders & the wet-ink signed documents binder.
• Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File).
• Respond to problems and assist in implementing corrective and preventive actions.
• Assist in providing internal communication of important clinical data and events.
• Support ongoing use of Clinical Trial Master Service (CTMS) by maintaining and tracking relevant activities.
• Provide safety documentation to other functional groups in support of safety committee meetings as requested.
• May be asked to provide support for study supplies creation, ordering, and distribution to the sites e.g. print protocols, and burn DVDs.
• May be asked to assist with Device tracking and order if required and if applicable.
• Assistance with logistics for Investigator meetings/expert panel meetings
• Assistance with the distribution of newsletter (create a mailing list from Clinical Trial Master Service and routing for internal approval)
• Participates in process improvement activities related to the department.
• May provide other administrative support for the clinical study or departmental activities as needed and assigned by the supervisor or study leaders.
  

Education and Experience:

• A minimum of a Bachelor's Degree is required.
• Requires previous administrative support experience or equivalent, preferably within a Clinical Research environment.
• Clinical/medical background a plus.

Specific Role Requirements and Skills:

• Requires experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and PowerPoint).
• Demonstrated competencies in the following areas are required: Tracking, Written and verbal communications, Attention to details
• Organizational skills

Our Benefits of Working for TalentSource in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Dedicated Line Manager
• Regular face-to-face or phone meetings with the 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 acknowledgment that we received it. If you have the requirements we need, you will be invited for a 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.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, 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 all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is 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 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 Trial Specialist, Clinical Study Specialist, Clinical Study Assistant, Clinical Research Specialist, Project Specialist, Project Assistant, Clinical Specialist, Clinical Assistant, Clinical Trial Assistant, Clinical Trial Administrator, Administrator, Admin, TMF, CTMS, CTA, Clinical Trials, Submissions, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Skills: Administrative Assistant, Clinical Trial Assistant, Clinical Trial Specialist, Project Assistant, clinical trials, CRO, Outsourcing, TMF Location: Belgium Share:

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