ProClinical are seeking an individual to fill the role of Senior CRA, based in New Jersey. The successful candidate will support clinical trial management with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting.
- Assist in managing and or leading the day-to-day operations of assigned studies.
- Participate in and may facilitate cross-functional study teams.
- Liaise with other functional areas to accurately coordinate clinical study activities.
- Coordinate clinical study timelines with Project management to meet critical milestones.
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports.
- Provide regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders.
- Participate in developing study plans and system setup. Ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
- Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
- Create and conduct training sessions including investigator meetings and team trainings.
- Provide oversight and direction to study team members for study deliverables.
- Assist with oversight of CRO and help prepare metrics and updates for management.
- Manage and files documents within electronic and/or paper Trial Master File.
- Assist in review of study documents for accuracy and completeness
- Perform or oversee CRO pre-site selection and site initiation, as well as interim, close-out, and monitoring visits.
- Review and manage monitoring visit reports.
Skills And Qualifications
- BS in relevant scientific discipline required and 4+ years of clinical trials (Phase 2/3) experience in the pharmaceutical or biotechnology industry.
- Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Strong experience in management of CROs and other vendors.
- Experience in ophthalmology clinical development strongly preferred.
- Proven project management skills and study leadership ability required.
- Excellent written, verbal, and interpersonal communication skills.
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 call Matt Tong at (+1) 646-878-6308 or upload your resume 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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