For one of our clients we are urgently looking for a Start up specialist.
The ClinOps Department will be involved in several new projects and needs the support of an additional Local Study Lead. The Local Study Lead (LSL) is responsible for the preparation of a clinical trial according to quality standards and timelines in their OPU, as well as cross-functional collaboration during conduct.
In preparation phase:
* Participate in team meetings initiated by CML or study team and provide information on the status of the study.
* Ensure that local adaptations to monitoring manual are made (if needed).
* Identify, select and manage vendors on local level
* Maintain Trial Master File (TMF) up to date.
* Ensure input is timely given for completeness of CTMS.
* Check and prepare on-site logistics e.g complete IRT shipping forms
* Collect essential documents for submission in collaboration with CRA, CTA officer and PM.
* Preparation of local Subject Information (SI)/Informed Consent Form (ICF) and other required trial documents for submission, TMF and Investigator Site Files (ISFs).
* Conduct and document Pre-trial contacts and support the site selection process
* Arrange supplies/materials/NIMP/equipment in collaboration with COL
* Provide site and trial information to COL for budget and contract negotiations.
In initiation phase:
* Ensure proper handover of trial to CRO-CRA
* Participate in the Trial Initiation visit at site together with the CRO-CRA and ensures that the site staff is trained in protocol and related documents and procedures.
* Ensure that all essential documents are available before initiation,
* Maintain TMF up to date on OPU and site level
* Ensure completeness of CTMS
In conduct phase:
* Support CTA officer with adaptation of documents for substantial amendment submission .
* Adjustment of local SI/ICF and other required trial documents for submission (substantial amendment) .
* Support audits and inspections on site level.
* Experienced CRAs or Start-up specialists (at least 2 years of experience)
* Experience in starting up clinical trials: from feasibility, site qualification, submission to initiation
* Experience in Oncology is an asset
* Language knowledge : Dutch,French,English
* Very good communication skills
* 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