Senior Clinical Research Associate

Kapadi, a Humaneva Group company, is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. As we continue to grow, we are looking for a highly-motivated Senior Clinical Research Associateto help us deliver new, life-changing therapies for the cancer patients who need them.

As aSenior CRA, 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.

Knowledge, skills and abilities:

• 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.