Clinical Research Associate

Job not on LinkedIn

🔥 36 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $80k / year

⏰ Full Time

🟡 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 to ensure data integrity, regulatory compliance, and adherence to GCP guidelines • Evaluate clinical trial resourcing requirements for site qualification, initiation, monitoring, and site support • Work with multiple trial sites and studies across varying indications simultaneously • Develop and maintain monitoring plans for assigned clinical trials • Liaise with clinic and hospital investigators and staff throughout study conduct • Oversee trial site setup and ensure sites have appropriate trial materials • Oversee site activation processes • Develop and monitor metrics for monitor and site performance; evaluate causes and mitigate study risk • Review data to identify issues or inconsistencies in collection or monitoring • Track patient enrollment and recommend solutions to increase appropriate enrollment • Support processing of data queries, deviations, adverse events, and related items • Write monitoring visit reports • Develop and execute trial 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 from study start to end • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree required, preferably in Clinical Research, Life Sciences or a related field • 3 years of relevant experience in industry or has worked with Sponsor companies as a clinic coordinator required • Prior study supervision experience required • Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred • Clearance of favorable background investigation required • Valid Class “C” drivers license • In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology • Strong organizational and problem-solving abilities with an eye for detail • Proficiency with Microsoft Office (Word, Excel, PowerPoint) • Effective verbal and written communication skills • Ability to work both independently and collaboratively in a fast-paced environment • Capacity to manage travel and multiple site relationships simultaneously • Working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, relevant regulations/standards, and internal organizational policies and SOPs • Ability to start job responsibilities punctually, maintain consistent presence throughout the entire shift, and attend scheduled meetings and appointments • Flexibility to work outside normal business hours on weekdays or weekends with reasonable advance notice • Must be able to manage travel and multiple site relationships simultaneously

🏖️ Benefits

• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary