Clinical Research Assistant or Clinical Research Coordinator - 247968

Benefits

Qualifications

• •Ability to lift up to 35 pounds, occasionally more
• •Must have a valid driver’s license and daily access to a car
• •Ideally, at least 1 years in Clinical Research
• •Solid understanding of clinical research methodologies
• •Strong leadership and team management capabilities
• •Effective collaboration with operational teams
• •Excellent verbal and written communication
• •Proficiency in Office 365 and other relevant software
• •Experience drafting and reviewing Standard Operating Procedures
• •Strong problem-solving, risk assessment, and analytical skills
• •Demonstrated process improvement experience
• •Effective negotiation and conflict resolution skills
• •Ability to multitask, prioritize tasks, and remain flexible
• •Independent thinker able to influence and drive decisions when needed
• •11 more items(s)

Responsibilities

• •Coordinate and manage complex activities throughout the start-up, conduct, and close-out phases of clinical pharmaceutical and device research studies
• •Ensure timely, accurate, and objective data collection in compliance with companies Research SOPs, federal regulations, GCP, ICH guidelines, IRB requirements, and specific sponsor protocols
• •All work should align with company Research’s Core Values, Mission Statement, and Employee Manual
• •Thoroughly understand assigned protocols and ensure all patient visits and procedures are completed as specified
• •Accurately document patient assessments, observations, test results, and other study-related data following federal regulations and protocol requirements
• •Obtain informed consent from patients in compliance with federal regulations, GCP, and IRB requirements
• •Strategically recruit eligible study subjects to meet enrollment targets within sponsor timelines while upholding ethical and regulatory standards
• •Complete required training promptly
• •Schedule and conduct patient visits in line with protocol timelines
• •Maintain complete and precise source documentation for all study activities
• •Accurately complete and submit case report forms (CRFs/eCRFs) and sponsor worksheets
• •Safeguard the confidentiality of patient and study information in accordance with HIPAA, confidentiality agreements, and company policies
• •Promptly report adverse events to the supervisor and/or Principal Investigator/Sub-Investigator as appropriate
• •Notify the sponsor of Serious Adverse Events (SAEs) within 24 hours of awareness and inform the supervisor and Principal Investigator/Sub-Investigator
• •Manage and track study materials (e.g., study drug, CRFs, lab supplies) to ensure availability throughout the study
• •Maintain consistent communication and document interactions with the Team Lead I, Team Manager, Principal Investigator, Sub-Investigators, and other research staff
• •Participate in required training, conferences, and investigator meetings to remain current with evolving federal regulations and company policies
• •Continuously seek educational opportunities to deepen knowledge of clinical research processes and regulations
• •Perform study-related tasks efficiently and cost-effectively, always adhering to company policies
• •Follow safety procedures in all activities
• •Represent company Research professionally and courteously in all interactions—verbally, in writing, and in appearance—with patients, staff, sponsors, and external partners
• •Carry out additional duties as assigned by management
• •Primarily office-based work environment
• •Exposure to human bodily fluids and lab processing
• •Direct patient care responsibilities
• •Daily use of computers
• •Occasional evening and weekend work
• •24 more items(s)