Senior Clinical Research Associate

Kapadi; Germany (OH); Hybrid; USD 80,598 - 103,626; Full time

Job summary

Kapadi is seeking a Senior Clinical Research Associate to lead monitoring and site management for Phase I–IV oncology trials in Germany, on-site or remotely. You will serve as the primary liaison across the study lifecycle, ensure GCP compliance, and support site activation and data integrity.

The role requires a Bachelor’s in Life Sciences or equivalent, 5+ years in clinical R&D, and oncology monitoring experience. Travel within Germany is expected in a CRO environment.

Qualifications

• Bachelor’s Degree 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 CRO.
• Oncology trial monitoring experience required.

Responsibilities

• 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.

Skills

Oncology

GCP/ICH knowledge

Clinical R&D

Site monitoring

Data review

Communication with sites

Travel willingness

Education

Bachelor’s Degree in Life Sciences/Medicine/Pharmacy/Nursing

Tools

ISF/TMF review

Job description

Kapadi 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 Associate in Germany to help us deliver new, life-changing therapies for the cancer patients who need them.

As a Senior 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.