|My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their clinical team in Switzerland, Vaud Canton.
Due to this growth my client is looking for an experienced CRA to join them in Lausanne area.
•Oversees clinical trial set up including site selection and set-up.
•Coordinates the overall interaction with clinical study sites and monitors CROs/site activities.
•Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.
•Manages site closure activities of assigned sites with CRO.
•Ensures quality and compliance with relevant regulatory standards according to procedural documents, international guidelines such as ICH and GCP as well as relevant local regulations.
•Identifies and qualifies clinical sites to ensure quality investigative sites.
•Review protocol for operational feasibility and organize feasibility studies to ensure appropriate country selection.
•Lead and coordinate the selection of investigators and ensure that the appropriate selection process has been utilized.
•Establish country and/or site-specific recruitment targets with internal / External CRAs and CPM to meet timelines.
•Participate in CRO and other third party vendor selection; assist with the review of proposals and attend bid defenses as required.
•Development and/ or review of assigned study documentation (e.g. Protocol, ICF, Monitoring Plan, eCRFs).
•Coordinate and/or organize technical training at investigator meetings, CRO/CRA training meetings.
•Ensure that all regulatory approvals have been obtained before initiation visits are conducted & that the appropriate documentation is available.
•Ensure that appropriate documentation is available to the investigators in a timely manner.
•Ensure that clinical trial supplies are made available to investigators along with any other materials required by the protocol.
•Participate in the set-up & user testing (UAT) of any systems used during a study e.g. eCRF/EDC, IRT, central laboratory portals etc. This includes review of relevant vendor documentation (system specifications, validation etc.).
•Manage, track and document CRO CRA activities by reviewing monitoring reports, tracking on-site visit frequency, organization of on site quality control visits as appropriate.
•University degree, preferably in life sciences or equivalent qualification.
•Minimum of 3 years progressive relevant clinical experience in clinical operations as Clinical Research Associate with Pharma/Biotech and/or CRO.
•Good knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
•Good knowledge of relevant local regulations.
•Basic understanding of the drug development process.
•Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
•Fluent in English