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 our clients procedural documents.
A CTA works in collaboration with trial team members on one or several and clinical trials.
CTA 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 on OPU, ROPU or trial level 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 an filing on OPU/ROPU/trial level 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 (R)OPU trial team.
- Finalize and communicate the final trial-specific LoER to CT Manager and 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)
- 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 CT. 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.
- Provide country and site-specific exceptions to TRS for creation of final list of exceptions.
- Inform the CT Manager about identified exceptions on country and site level and provide final list when all records are received.
- Provide confirm that archiving pre-requisites have been met for country and site level records to TRS
- In case trial activities are outsourced to a vendor, this includes all MIDI, OPU and site level documentation, working regionally as appointed MIDI CTA after trial initiation.
- Provide inspection readiness related support.
- Experienced CTAs (at least 2 years of experience)
- Able and willing to work both on regional and local level
- French speaking with at least basic knowledge of Dutch (or vice versa) and very good communication skills in English
- Able and willing to adapt easily to a changing environment (important!)
- Able to learn how to use different systems and databases quick via e-learning
- Pro-active, positive and eager-to-learn