Sr. CRA
Sr. CRAs support as assistant CTMs. A good background would be experience as a lead or principal CRA which is just above Sr. CRA. We’re looking for Lead CRAs.
Monitoring: review of monitor reports, has written monitoring plans, knows what to capture; able to do co-visits as needed
Vendors: understand contracts; familiar with what has been established and can manage against expectations; offer input during vendor selection; understand how vendor management plays in to it all; keep all on track
Site and country feasibility studies; questionnaires
Develop clinical slides to present to vendors, CRA team; able to review CRO slide deck
Position Summary:
The Senior Clinical Research Associate (Sr. CRA) is a critical position within the clinical team. In close collaboration with the Clinical Trial Manager, Clinical Operations & Regulatory Affairs leadership, the Sr. CRA will work to manage and monitor clinical trial sites and will function as the Sr. CRA for clinical trials. The Sr. CRA will partner with Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget.
Assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
Essential Duties and Responsibilities:
- Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) to accurately coordinate clinical study activities
- Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
- Accurately update and maintain clinical systems within project timelines
- Provide regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Participate in developing study plans and system set-up; participate in preparation and 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
- Oversight of vendor management activities and deliverables
- Work on study feasibility assessments and selection of countries and sites for study conduct
- Create and conduct training sessions including investigator meetings and team trainings
- Provide oversight and direction to study team members, including vendors, for study deliverables
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP’s
Qualifications:
- BA/BS degree with at least 6 - 8 years of relevant monitoring and vendor oversight experience, or advanced degree (MS) with at least 4 years clinical trial management experience
- Must have strong knowledge of ICH/GCP guidelines
- Must have 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
- Proven project management skills and study leadership ability required
- Must have excellent interpersonal, written and verbal communication skills, and administrative skills
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
- Ability to “roll up your sleeves” and individually contribute results to a research and development effort