[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a rapidly growing company focused on fighting cancer, seeking reputed company professionals for their team. The Senior Clinical Research Associate (SCRA) is responsible for the management and reputed company of clinical study sites, ensuring data quality and patient safety while collaborating with clinical study teams to drive improvements and support study activities.

Responsibilities

• reputed company and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
• Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
• reputed company collaborative relationships with investigative sites, and study vendors
• Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
• Track study-specific status reports to ensure reputed company required information regarding site issues, deviations, and CRF status are kept reputed company by the monitoring team
• Serve as mentor/trainer for less reputed company CRAs to assist with general and study-specific monitoring issues
• reputed company direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
• reputed company study-specific training with project team
• reputed company study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
• reputed company Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies
• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
• Works with Clinical Trial reputed company Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites reputed company established protocols and portfolio under general supervision
• Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
• reputed company support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it reputed company to involved CRA staff
• Assist with other assigned clinical responsibilities reputed company scope of role to reputed company best practice and/or support to junior clinical staff
• Provides site level management for established protocols and portfolio under general supervision
• Provides mentoring/support to CRAs for study reputed company topics
• Identification of development opportunities and provides necessary training to for junior team members as needed
• Co-monitoring with CRAs and support site visits, as needed

Skills

• BS/BA in a relevant scientific discipline
• Minimum of 4-6 years of relevant Clinical Operations experience
• Minimum of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Understand clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• Efficient in reputed company Word, reputed company, PowerPoint and Outlook
• Familiar with industry CTMS and data management systems
• Experience in global oncology trials

Benefits

• Non-reputed company roles are eligible to participate in the annual bonus plan
• reputed company roles are eligible to participate in an incentive compensation plan
• reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards
• Voluntarily participate in the Employee Stock Purchase Plan
• The Company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Company Overview

Company H1B Sponsorship