Publié dans: Autres dans Pologne | Posté: |
Hobson Prior are currently seeking for a looking for an CRA Site Management to join a leading pharmaceutical organisation. This role will be on a permanent basis and will be located in Warsaw.
Please note that to be considered for this role you must have the right to work in this location.
Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Complies with relevant training requirements.
Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team, as required.
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial.
Drive study compliance by executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site is equipped to carry out the trial with adequate site study supplies and clinical drug supplies. This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
Ensures quality data is provided by the site and queries resolved within expected timelines.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations and archiving retention requirements, including storage in a secure area at all times.
Focuses on Investigator engagement through timely follow up with sites. Completes follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders. Follows the corresponding Monitoring Guidelines for each assigned trial.
Any other assigned duties.Key Skills:
Strong IT skills in appropriate software and company systems.
Willingness to travel with overnight stay away from home according to business needs.
Proficient in speaking and writing in English and the country language where services will be provided. Effective communication skills, oral and written.Requirements:
BA/BS degree/Degree in a health or science related field or equivalent industry experience.
2 years of clinical trial monitoring experience or equivalent industry experience and completion of a monitoring training course.
3 to 5+ years of clinical trial monitoring experience.
Specific therapeutic area experience depending on the services need.
Strong working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy