Senior Clinical Research Associate

Job not on LinkedIn

🔥 11 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 23%

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Humaneva Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💊 Pharmaceuticals

🤝 B2B

💰 $50M Private Equity Round - Humaneva on 2024-09

Healthcare • Pharmaceuticals • B2B

Humaneva Group is a clinical-research-focused organization that integrates patient care, scientific innovation, and data-driven approaches to provide reliable clinical research data to the medical community. The Group comprises three interrelated companies: a research site network, a contract research organization (CRO), and a technology platform that together create a connected data stream between patients, investigators, research centers, and data standards. Humaneva emphasizes integration of clinical operations with technology and appears to support therapeutic areas such as oncology, according to its site navigation.

📋 Description

• Perform monitoring and site management activities for Phase I-IV clinical research projects at assigned investigative/physician sites • Serve as the primary liaison for project site personnel throughout the study lifecycle, from site identification through close-out • Support site identification and site start-up • Perform site evaluation, site initiation, interim monitoring, and close-out assessments on-site or remotely • Perform telephone assessments and central monitoring remotely • Ensure regulatory, ICH-GCP, and protocol compliance • Verify informed consent processes are adequately performed and documented • Assess patient safety and clinical data integrity risks, including protocol deviations and pharmacovigilance issues • Assess site processes and facilities and conduct Source Document Review and Source Document Verification • Apply query resolution techniques, perform investigational product accountability, and review the Investigator Site File and Trial Master File reconciliation • Support subject/patient recruitment, retention, and awareness strategies • Enter data into tracking systems and track observations, status, and action items through resolution • Review study and site data listings, visualizations, analytical dashboards, and reports to identify trends, risks, suspected scientific misconduct, and systematic errors • Collect essential documents and compile document packages for site activation

🎯 Requirements

• Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience • Minimum of 5 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses • At least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies • Oncology trial monitoring experience required • Demonstrated knowledge of oncology therapeutic area and early phase research design • Demonstrated proficient computer skills and ability to embrace new technologies • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Ability to travel domestically and meet with sites within their institutions

🏖️ Benefits

• Employee position • Remote work arrangement • On-site or remote monitoring activities • Domestic travel opportunities/requirements

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