Clinical Research Associate

🔥 23 minutes ago

🇺🇸 United States – Remote

💵 $80k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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Extremity Care

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

📦 Logistics

⚕️ Healthcare Insurance

Healthcare • Logistics • Healthcare Insurance

Extremity Care is a company focused on cell and tissue technologies that support the repair, reconstruction, replacement, or supplementation of the patient’s own tissue. They specialize in the compliant handling of allogeneic and xenograft tissue, providing logistical support for clinics throughout the ordering and shipping process. Their product offerings include placental and adipose tissue allografts, collagen-related products for wound care, and a range of other tissue management solutions to support healthcare professionals in managing both acute and chronic wounds.

📋 Description

• Oversee operational aspects of clinical trial conduct at investigational sites • Evaluate clinical trial resourcing for site qualification, initiation, monitoring, and site support • Work with multiple trial sites and studies across varying indications • Develop and maintain monitoring plans • Liaise with clinic and hospital investigators and trial staff • Oversee trial site setup and ensure appropriate trial materials are available • Oversee site activation processes • Develop and monitor metrics evaluating monitor and site performance • Review data for issues or inconsistencies in collection or monitoring • Track patient enrollment and recommend solutions to improve enrollment of qualified subjects • Support processing of data queries, deviations, and adverse events • Write monitoring visit reports • Develop and execute site close-out plans and activities • Ensure adherence to ICH-GCP, SOPs, IRB regulations, study protocols, FDA regulations, and ICH guidelines • Coordinate data management activities • Generate protocol and informed consent drafts for management review • Create literature reviews for new study indications • Assist with CRF development and investigator meetings • Create study status data tables and slide decks for upper management review • Create and maintain study site investigator binders • Maintain working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, relevant regulations, and organizational policies • Start responsibilities punctually, maintain consistent presence throughout shifts, and attend scheduled meetings • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree required, preferably in Clinical Research, Life Sciences or a related field • CRA certification such as CCRA or CCRP strongly preferred • 3 years of relevant experience in industry or experience working with Sponsor companies as a clinic coordinator required • Prior study supervision experience required • Favorable background investigation required • Valid Class “C” driver's license • In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology • Proficiency with Microsoft Office (Word, Excel, PowerPoint) • Strong organizational and problem-solving abilities with attention to detail • Effective verbal and written communication skills • Ability to work independently and collaboratively in a fast-paced environment • Ability to manage travel and multiple site relationships simultaneously • Flexibility to work outside normal business hours on weekdays or weekends with reasonable advance notice

🏖️ Benefits

• Remote work • Full-time employment • Up to 50% travel required for the role