Contract - Senior Clinical Research Associate

CONTRACT - SENIOR CLINICAL RESEARCH ASSOCIATE

Position Summary:

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
• 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 2 - 4 years' clinical trial management experience, or advanced degree (MS) with at least 2 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
• Ability to travel up to 25%