Description
Join a forward-thinking team where Risk-Based Monitoring is at the heart of how the team works. As a Clinical Research Associate (CRA), you'll collaborate with sites, data-driven insights, and focus on activities that truly impact study quality, patient safety, and success of the trial.
Responsibilities:
- Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Conducts Source Document Review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- Applies query resolution techniques remotely and on-site, and provides guidance to site staff as necessary.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- Supports 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.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Qualifications:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Previous monitoring experience in Germany, preferably in oncology.
- Experience in risk-based monitoring is a plus.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Fluency in German and English.
- Location in north-east Germany.
- Ability to manage required travel of up to 75% on a regular basis.