Senior Clinical Research Associate – English fluent – Pharma – Vaud
My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior Clinical Research Associate has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study teams. You will work in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You may oversee regular CRA activities including contract CRAs.
Summary of responsibilities:
- Oversees clinical trial set up including site selection and set-up.
- Coordinates the overall interaction with clinical study sites and monitor CROs/site activities.
- Key contributor to site identification and site selection.
- 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.
- Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.
- Ability to manage a phase 1 or small phase 2 clinical trial.
- 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.
- In collaboration with the CPM, make recommendations for the appropriate outsourcing of any required functions (e.g. monitoring, laboratory services etc.) and participate in the preparation of the related documentation.
- Assist the CPM with the preparation of bid grids, budgets and significant study milestones.
- Establish country and/or site-specific recruitment targets with internal / External CRAs and CPM to meet timelines.
- In collaboration with line function manager and CPM, 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.
- Be responsible for and hold CROs accountable for contracted tasks relating to data monitoring and site quality.
- Track recruitment and take appropriate steps to ensure recruitment targets are met; ensure Clinical Project Manager is fully informed & collaborate with CPM to identify issues, trends, resolutions and/or corrective actions.
- Track, measure and report any deviations versus the planned timetable; identify the causes and provide solutions.
- Minimum of 5 years progressive relevant clinical experience in clinical operations including 3 years as Clinical Research Associate or equivalent with Pharma/Biotech and/or CRO.
- Drug/device combination and biologics experience preferred.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Excellent knowledge of relevant local regulations.
- Good understanding of the drug development process.
- Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
University degree, preferably in life sciences or equivalent qualification
Please send your CV to Jean de La Fournière: firstname.lastname@example.org