ProClinical is advertising a vacancy for a CRA with a leading biopharmaceutical development company. This Rare Disease Drug Development Company organization in-licenses novel compounds, develops them through the pre-clinical and clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
The CRA will work in a home-based capacity on a contract basis, and provide oversite and site qualification, along with expertise in regulatory practices. This is an exciting opportunity to work with a company that has contributed to developments in the oncological field.
- Overseeing the entire site management process for the life cycle of the trial sites, developing and maintaining trial documents, and logging and tracking of site performance metrics
- Ensuring site qualification (pre-study), initiation, monitoring and study closeout visits are conducted in accordance with federal regulations, Good Clinical Practices, ICH Guidelines, Standard Operating Procedures, and business processes.
- Monitoring activities of assigned sites and acting as primary liaison for all clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager.
- Ensuring appropriate CRA visit scheduling per protocol and monitoring plan, with reporting on monitoring activity to include status report, co-monitoring (qualification) visits, and trip report metrics.
- Collaborating with the relevant staff to develop any Corrective and Preventative Action Plan (CAPA).
- Ensuring that the CAPA is delivered and issues escalated to the CPM
- Assisting sites, internal staff, and other clinical staff with the preparation for GCP audits, including file review according to the clinical project plan.
- Reviewing and entering all protocol deviations in collaboration with the all relevant staff.
- Developing and maintaining a country recruitment/retention strategy in collaboration with the Clinical Project Manager (CPM); Identifying potential risks to the enrolment targets based on feasibility and recruitment updates in collaboration with the CPM.
- Attending, participating, and presenting at Investigator meetings as needed
- Supporting the relevant staff in communicating and resolving issues and obtaining follow-up information
Skills and Requirements:
- Approximately seven years of experience in running clinical trials, ideally pharmaceutical, biotechnology or CRO and/or a healthcare setting. Of these, three to four years must have been directly related to the management of site performance in accordance with clinical trial execution.
- Demonstrable and extensive Oncological experience.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at + 44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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