Clinical Trial Assistant
Job description
As a Clinical Trial Assistant (CTA) you hold an essential position within a clinical operations team. You are responsible for supporting clinical drug research by working closely with Clinical Research Associates and Clinical Project Managers. You are involved in study start-up, administration and filing of essential documents.
Responsibilities
- Support during the feasibility process (e.g. preparation and follow-up of Confidentiality Agreements, retrieve completed Feasibility Assessments, complete feasibility tracker)
- Coordinate translations of study documents
- Assist in preparation of submission package to ECs/HA
- Prepare documents for Site Initiation Visits (creation of site specific documents)
- Set-up and distribution of Investigator Site Files
- Set-up of study tracking tools
- Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File to support readiness for audits and inspections
- Logistic management of non-study drug related supplies/services
- Support in local study process, presentations, mailing to sites, newsletters and correspondence
- Assistance in preparation, support during conduct of audits and inspections
- Support and follow-up of local team meetings and local investigator meetings (e.g. attendee list, agenda, meeting materials, writing of minutes)
- Set-up of (e)TMF files and in-house filing of TMF documents in the appropriate files according to the SOP and ICH-GCP and other local guidelines
- Support ongoing use of CTMS by maintaining and tracking relevant activities.
Profile
- Minimum of a Bachelor’s Degree is required
- Previous clinical research experience a plus
- Requires previous administrative support experience for at least 1 year
- Knowledge of Good Clinical Practices (GCP)
- Belgian residence required, since this vacancy is office based
Demonstrated competencies/skills in the following areas are required:
- Awareness and understanding of cultural differences as well as regional operational differences
- Excellent written and verbal English communication skills, preferably also good knowledge of Dutch/French
- Interpersonal, decision-making and issue resolution skills
- Effective planning and organization skills
- Computer skills (Microsoft office – Excel, Word and Power Point)
- Attention to detail
- Excellent follow through
Our offer
- An attractive salary in line with your experience and skills
- Fringe benefits including a company car, meal allowance, medical insurance, pension plan and a care plan
- A supporting environment
- Respect for the life-work balance
- Career planning
- A focus on professional and personal growth through training and coaching
- Room for personal engagement to help shape our company's future
Location
Brussels & Flanders
Contact person
Evelien Van Eecke
Evelien
Van Eecke
Clinical Talent Specialist
Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.
+32 476 98 62 94
evelien.vaneecke@fern-valley.com