Senior Clinical Research Associate, Dermatology, Rheumatology

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🔥 0 minutes ago

🌵 Arizona, Kansas, +1 more states – Remote

🌵 Arizona – Remote 🌪️ Kansas – Remote 🎰 Nevada – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Monitor the progress of clinical studies at investigative sites or remotely • Ensure clinical trials are conducted, recorded, and reported according to protocols, SOPs, ICH-GCP, and applicable regulatory requirements • Conduct site qualification, initiation, monitoring, and close-out visits according to monitoring plans, SOPs, guidelines, and regulations • Participate in investigators’ meetings • Prepare site visit reports and follow-up letters to investigators • Build productive relationships with investigators and site staff to achieve study objectives and patient recruitment targets • Perform source data verification • Ensure adequate on-site study drug storage, dispensing, accountability, data collection, and regulatory document collection • Review and approve site visit reports as a Lead CRA • Track site visit and trip report metrics and escalate issues to project teams • Recommend solutions to identified issues and work with project managers on resolutions • Support development of annotated site visit reports, clinical monitoring plans, and monitoring tools • Support preparation and development of CRA training materials • Mentor CRAs • Conduct on-site quality control visits with CRAs

🎯 Requirements

• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience • At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry • Rheumatology exposure • Experience in dermatology • Good knowledge of ICH/GCP standards and applicable regulatory requirements • Strong verbal and written communication skills in English • Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines • Excellent judgement and problem-solving skills • Willingness to travel to research sites approximately 65% of the time • Excellent knowledge of Microsoft Office, including Word, Excel, and PowerPoint • Applicants must be legally authorized to work in the US regions

🏖️ Benefits

• Stimulating work environment • Attractive advancement opportunities • Recruitment interviews conducted via Teams and video conference • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request