[Hiring] Senior Clinical Research Associate @Humaneva Group

Role Description

As a Senior Clinical Research Associate, you will:

• Perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely).
• Serve as the primary liaison for project site personnel throughout the study lifecycle from site identification through close out, including site identification and site start-up support.
• Perform site evaluation, site initiation, interim monitoring, and close-out assessments (performed on-site or remotely), telephone assessments and central monitoring (performed remotely), and site management, ensuring regulatory, ICH-GCP, and protocol compliance.
• Verify the process of obtaining informed consent has been adequately performed and documented for each patient as appropriate.
• Assess factors that might affect patient safety and clinical data integrity at a site such as protocol deviations and pharmacovigilance issues.
• In accordance with the CMP, assess site processes and facilities, conduct Source Document Review and Source Document Verification.
• Apply query resolution techniques remotely and on site, perform investigational product (IP) accountability, and review the Investigator Site File (ISF) and reconcile with the Trial Master File (TMF).
• Support subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Review study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.
• Collect essential documents from the site, review and compile essential document packages for site activation.

Qualifications

• 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.

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, including 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.