Job Posting Covance is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries.
Due to our continuous growth, we are looking for experienced
Freelance Clinical Research Associates, across the UK
About the opportunity
We are seeking to engage with Freelance CRAs able to commit with us for a 6 months length contract.
You will be:
Responsible for all aspects of study site monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaise with vendors and other duties
Ensure the study staff has received the materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
Responsible for all aspects of site/registry management as prescribed in the project plans
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Education/Qualifications Typically required :
University/college degree (life science preferred), or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology). In lieu of the above, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered as well.
Thorough knowledge of and experience with monitoring procedures.
A valid driving license.
Experience Typically required :
Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
Experience at working at UK sites (1 year min.) is a must
Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process.
Good planning, organization and problem solving abilities.
Good communication and interpersonal skills.
Professionals able to commit at 0.8 FTE
Travel up to 60 % of the time, including overnight stays as necessary Education/Qualifications jd Experience jd