Senior Clinical Research Associate, Contractor

November 27

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AIXIAL GROUP

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Biotechnology • Pharmaceuticals • Healthcare Insurance

AIXIAL GROUP is a leading Clinical Research Organization (CRO) committed to delivering efficient clinical trials. They offer full-service clinical trials, functional service provision, and consulting support for clinical development. Their areas of expertise include oncology, radiopharmaceuticals, cell and gene therapy, rare diseases, and real-world evidence. AIXIAL GROUP focuses on applying advanced technology for clinical data management and offers solutions from the early phase to phase II/III CRO services, including decentralized trials. They cater to the needs of biotech and pharma companies worldwide, offering expertise in specialized therapeutic areas to ensure successful clinical trials.

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Responsible for site management and monitoring activities associated with clinical studies • May be assigned to monitor a specific study or studies, co-monitor with other CRAs or provide other support to Clinical Operations • Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements, and appropriate SOPs • Confirm investigator adherence to ICH GCP, local regulatory requirements, and to the protocol procedures • Adhere to the project plans, as applicable, for assigned studies • Complete and submit timely site visit reports per the monitoring plan/SOPs • Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting • Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff • Discuss, review, and document patient recruitment strategies with assigned sites • Work with Global Project Leader (GPM), and/or Clinical Team Lead (CTL) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan • Support assigned sites with vendor issues as they arise • Provide any additional training as identified throughout the study to site staff as needed • Assist in the development of study-related trackers and monitoring tools as requested • Review, in conjunction with Clinical and/or Data Managers, the quality and integrity of the clinical data through source data review and verification • Liaise with Data Management during all stages of a study to assist with query resolution as required • Assist the GPM and/or CTL with updating study metrics and compiling status reports • Participate in department initiatives to enhance Clinical Operations

🎯 Requirements

• Bachelor’s (or equivalent) degree in science, medical health, or related discipline or equivalent relevant experience • Fluent English is required • A minimum of five years of clinical monitoring experience in the Pharmaceutical/CRO industry • Good clinical and therapeutic knowledge with understanding of medical and pharmaceutical industry terminology • Strong knowledge of ICH-GCP guidelines and applicable regulations • Excellent oral and written communication skills • Medical professional with experience in clinical research (desirable) • Experience in different therapeutical areas (desirable) • Proactive problem-solving skills (desirable) • Interpersonal and organizational skills with strong attention to detail (desirable) • Excellent computer skills (desirable) • Skills in working with Microsoft Office products, particularly Word, Excel, PowerPoint (desirable)

🏖️ Benefits

• Remote work • Flexible work arrangements