Senior Clinical Research Associate – Contractor

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Perform feasibility studies for potential sites • Conduct pre-study, study initiation, interim monitoring, and site close-out visits • Function as Lead CRA for global studies and coordinate CRAs • Develop Clinical Monitoring Plans • Review site visit trip reports • Mentor and guide less experienced CRAs and site staff • Design study-specific tools and templates • Participate in study team, investigator, and bid defense meetings • Create and conduct training for study team members and colleagues • Work with Project Management to evaluate deliverables and study milestones • Compile regulatory and ethical submission documentation • Coordinate shipment and receipt of study materials • Document site visit findings in written reports • Provide input into protocol and CRF design • Assess, monitor, and train site staff on protocol adherence • Review safety information and informed consent • Conduct source document verification • Review CRFs and assist with data query resolution • Assist with Investigator Site File maintenance • Maintain regular communication with study sites • Update site-related documentation for filing in the Trial Master File • Ensure site compliance with investigational product receipt, accountability, and return or destruction • Conduct accompanied site visits for CRA assessment or training • Complete final site close-out visits and reports • Perform other assigned duties

🎯 Requirements

• MD, Pharmacist, or equivalent pharmacy degree with at least 3 years of Clinical Research Associate experience; OR • Four-year college curriculum in medical, biological, physical, health, pharmacy, or related science with at least 5 years of Clinical Research Associate experience; OR • Two-year college curriculum or equivalent education/training, with at least 7 years of Clinical Research Associate experience • Nursing degree or equivalent life science degree preferred for the two-year curriculum route • Willingness to travel • Valid current passport • Driving license • Fluent in the local languages of the countries under responsibility • Proficient spoken and written English • Excellent oral and written communication skills • Excellent planning, organizational, and time-management skills • Excellent interpersonal skills • Initiative and problem-solving skills • Ability to lead and motivate an assigned team, if applicable • Ability to contribute experience and input to process initiatives related to monitoring and site management • Extensive understanding of clinical research principles and processes • Thorough understanding of FDA and/or EU directives and regulations, ICH Guidelines, and local regulatory requirements • Thorough understanding of two to three therapeutic areas sufficient to function as Lead CRA • Thorough understanding of standard operating procedures • Proficiency in Microsoft Office • Proficiency with IxRS and EDC systems

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible, hands-on leadership • Equal employment opportunities • Exceptional employee experiences • Opportunities for mentoring and professional development through guidance and training activities