Senior Clinical Research Associate – CRO Contract

🔥 0 minutes ago

🦀 Maryland – Remote

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💵 $0 - $110 / hour

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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Evolution Research Group

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Independently manage and monitor site activities for assigned clinical studies • Conduct site qualification, site initiation, interim monitoring, and close-out visits • Perform site evaluation visits and assess investigator-site capability • Conduct study initiation activities, review protocols and regulatory issues, and train site personnel • Maintain audit-ready Investigator Site Files and ensure timely document upload to the Trial Master File • Communicate directly with investigational sites regarding visit planning, query resolution, action items, and site management • Document clinical-trial-material accountability, stability, and storage conditions • Perform investigational product inventory and coordinate return or destruction of unused materials • Serve as primary site contact and coordinate correspondence and timely clinical-data transmission • Perform study close-out visits, investigational-product reconciliation, site-file reconciliation, query resolution through database lock, and outstanding-action resolution • Complete internal and study-related training within required timelines • Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports • Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable • Follow safety practices while traveling and visiting clinical research sites

🎯 Requirements

• Bachelor's degree or equivalent experience in life science/healthcare • At least 5 years of field experience working within clinical research as a CRA • Mastery of the CRA II Job Responsibilities • Valid Driver's License • Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency • Ability and willingness to travel up to 100% of the time, both domestically by land and air • Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process • Proficiency in using electronic CRF platforms and processes • Excellent interpersonal, organizational, and attention-to-detail skills • Ability to work independently, manage multiple tasks, and meet multiple deadlines • Proficient computer skills and working knowledge of email, document, spreadsheet, and presentation software • Ability to submit invoices and expense reports in accordance with Finance Department requirements • Ability to follow safety, environmental, infection control, and protective-equipment guidelines • Ability to lift and/or carry up to 10 pounds

🏖️ Benefits

• Contractor is responsible for their own insurance • Home office environment available • Travel-related work opportunities

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