A leading global contract research organisation is seeking to recruit a CRA II/Senior CRA to their Belgian team on a home-based capacity. The company provides comprehensive, integrated drug development, laboratory, and lifecycle management services, working with partners across pharmaceutical, biotechnology, medical device, academic, and government organizations. This is an exciting opportunity to work with a company that has offices in 48 countries and more than 20,000 professionals worldwide, with a commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Job Responsibilities:
- Monitor investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
- Assess investigational product through physical inventory and records review.
- Document observations in reports and letters in a timely manner using approved business writing standards.
- Escalate observed deficiencies and issues to clinical management expeditiously, present potential solutions and follow all issues through to resolution.
- Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conduct monitoring tasks in accordance with the approved monitoring plan.
- Participate in investigator meetings as necessary.
- Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
- Perform trial close out and retrieval of trial materials.
- Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
- Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Respond to company, client and federal regulatory requirements/audits.
- Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner.
- Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Skills and Requirements:
- Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution. In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
- Valid Driver's License where applicable.
- Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job (comparable to one year) or completion of PPD Drug Development Fellowship.
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs.
- 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 with computer skills, such as MS Office.
To Apply:
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 Reem Iskandarani at +44 203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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