Clinical Trial Assistant
The Clinical Trial Assistant (CTA) works within the Clinical Operations team and is responsible for adequate administrative, logistic and operational support to clinical trials from start-up until completion, within defined time lines and in accordance with ICH-GCP and/or other ethical and regulatory requirements and procedural documents.
The CTA works in collaboration with the trial team members on one or several and clinical trials. The role includes the role of Local TMF Record Specialist (LTRS).
In addition, a CTA can have an additional role and/or can take an expert role/task (e.g Payment Manager).
The CTA is accountable for providing logistic support for clinical trials by:
- Preparation, support and attendance of meetings e.g kick-off meetings, trial team meeting, investigator meeting and follow-up on assigned action items.
- Support and assist the team with operational aspects of the trial
- Support in translation/back translation of trial documents
- Support in entering data for keeping the clinical trial management system up-to-date on country level, site level and trial level.
- Support in clinical trial payment process
- Support in correspondence and presentations
Essential records preparation and filing, including:
- Create and finalize country and site-specific List of Expected Records (LoER)
- Participate as appropriate in Trial Oversight Meetings and present TMF topics
- When the final trial-specific LoER is available, create the country and site-specific LoER in collaboration with the trial team.
- Finalize and communicate the final trial-specific LoER to CT Manager
- Update the trial-specific LoER if a main trial event is planned/occurs that has an effect on trial records (e.g. local CTP amendment)
CTA is accountable to maintain Trial Master File throughout trial
- Process and file records in TMF (country and site level)
- Collect, file or ensure availability of the final versions of records as defined in the electronic TMF (eTMF) Universe (all systems that hold TMF relevant records during or after the trial) on an ongoing basis during the conduct of the trial. Records can be in paper or electronic format.
- Perform quality checks for the records and resolve any discrepancies prior to filing.
- Process country and site level records according to whether they are expected or unexpected as per trial specific LoER.
- File expected country and site level records in TMF
- In case of unexpected country or site level records update the LoER.
- Closely collaborate with the TRS in order to provide feedback on the status, quality and completeness of the TMF during the entire life cycle of the trial.
CTA is accountable for Close out Trial Master File:
- Provide country and site-specific exceptions to TRS for creation of final list of exceptions.
- Inform the Clinical Trial Manager about identified exceptions on country and site level and provide final list when all records are received.
- Provide confirmation that archiving pre-requisites have been met for country and site level records.
- Provide inspection readiness related support.
- Minimum of a Bachelor’s Degree is required
- Previous clinical research experience is required (1-2 years)
- Knowledge of Good Clinical Practices (GCP)
- Belgian residence is required, since this position is office based in Belgium.
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
- Good knowledge of Dutch and 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
- An attractive salary in line with your experience and skills.
- Fringe benefits including a 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.
Evelien Van Eecke