Senior CRA - Phase I oncology trials - Hamburg/Berlin region

Senior CRA - Phase I Oncology Trials - Hamburg/Berlin Region

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Job Responsibilities

For one of our clients, a biopharmaceutical company, we are currently looking for a senior CRA. This role requires demonstrated proficiency in traditional on-site monitoring models, including full source data verification, investigational product accountability, and strict adherence to ICH/GCP and regulatory requirements.

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. 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 via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. 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.
• Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.

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
• Experience as CRA with a strong background in oncology clinical trials across all phases of development, including early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs
• Must demonstrate good computer skills and be able to embrace new technologies
• The ideal candidate will have hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer, and will be comfortable operating in fast-paced development environments where quality execution supports accelerated timelines and regulatory submissions. Prior exposure to investigational products involving Toll-Like Receptor (TLR) pathways, PARP1 inhibitors, or Werner helicase protein is desirable but not required.
• Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
• Multilingual capabilities, particularly fluency in English with French, German, and/or Flemish, are strongly preferred.
• Ability to manage required travel of up to 75% on a regular basis