Clinical Research Associate
An international staffing and recruiting company is currently recruiting a Clinical Research Associate to join their office in Florida on a remote basis. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape.
- Managing CRA team under buyer supervision to ensure effective communication with sites (day to day, formal, and newsletters), proper documentation for all IRB submissions/amendments, proper tracking, control of investigational product internally at the site, and proper maintenance of site regulatory binders and Trial Master File (TMF).
- Fostering the growth and development of CRAs through FDA, ICH, and GCP training.
- Performing assessment monitoring visits, reviewing monitoring visit reports, and following up on documentation to assess training needs for clinical team & site staff, tracking of protocol deviations & adverse events, and creation and resolution of action items.
- Performing final review of data internally for trends.
- Creating and implementing CTMS mapping for all study and regulatory documents.
- Working with Clinical Study Managers and Clinical Operations management to monitor resource allocation of CRAs across multiple projects to balance workloads.
- Assisting reviews of departmental procedures and recommending policy changes as needed.
- Providing expertise in start-up, execution, and close-out for studies.
- Performing audits and co-monitoring visits to ensure appropriate trial oversight and conduct.
- Mentoring/facilitating successful team behavior.
- Partnering with Clinical Study Managers to ensure project deliverables are met.
- Accountable for performance and compliance of assigned Regional CRAs and their investigative sites.
- Engaging in CRA candidate interview & selection process.
- Ensuring compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards, and regulations.
Skills and Requirements:
- University degree in life sciences, or equivalent knowledge gained through work assignments.
- 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.
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 Mary Jacobs at +496994189029 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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