CRA II​/Sr CRA Berlin or Hamburg

Position

CRA II/Sr CRA – Berlin or Hamburg

• Perform site qualification, site initiation, interim monitoring, site management, and close‑out visits (on‑site or remotely) to ensure regulatory, ICH‑GCP, Good Pharmacoepidemiology Practice (GPP), and protocol compliance.
• Use judgment and experience to evaluate overall site and site staff performance, provide recommendations for site‐specific actions, and immediately communicate or escalade serious issues to the project team while developing action plans.
• Maintain a working knowledge of ICH/GCP guidelines, other applicable guidance and regulations, and company SOPs/processes.
• Verify that informed consent procedures have been adequately performed and documented for each subject or patient as required.
• Demonstrate diligence in protecting the confidentiality of each subject or patient.
• Assess factors that may affect subject or patient safety and clinical data integrity at investigator sites, including protocol deviations/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan, assess site processes.
• Conduct source document reviews of appropriate site source documents and medical records.
• Verify that required clinical data entered in the case report form (CRF) is accurate and complete through review of site source documents and medical records.
• Apply query resolution techniques remotely and on‑site, provide guidance to site staff as necessary, and drive query resolution to closure within agreed timelines.
• Utilize available hardware and software to support effective conduct of clinical study data review and capture.
• Verify site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation, and review storage and security.
• Verify IP dispensation and administration to subjects or patients according to protocol.
• Verify issues or risks associated with blinded or randomized information related to IP.
• Apply knowledge of GCP, local regulations, and organizational procedures to ensure IP is appropriately relabelled, imported, and released or returned.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Reconcile contents of the ISF with the Trial Master File (TMF).
• Ensure investigators and physicians are aware of the requirement to archive essential documents per local guidelines and regulations.
• Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and the Clinical Monitoring Plan/Site Management Plan.
• Support subject or patient recruitment, retention, and awareness strategies.
• Enter data into tracking systems to monitor observations, ongoing status, and assigned action items toward resolution.
• Understand project scope, budgets, and timelines for own and others’ activities in the clinical team; manage site‑level activities and communication to ensure objectives, deliverables, and timelines are met.
• Adapt quickly to changing priorities to achieve goals and targets.
• May act as primary liaison with project site personnel or collaborate with the Central Monitoring Associate.
• Ensure all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
• Prepare for and attend investigator meetings and/or sponsor face‑to‑face meetings.
• Participate, and may with supervision, lead global clinical monitoring/project staff meetings (including sponsor representation as applicable) and attend clinical training sessions per project requirements.
• Provide guidance at the site and project level toward audit readiness standards and support preparation for audit and required follow‑up actions.
• May provide training or mentorship to junior CRAs.
• May perform training and sign‑off visits for junior CRA staff, as assigned.
• May be mentored and assigned clinical operations lead tasks under the supervision of an experienced Clinical Operations Lead (COL) or operational line manager.

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical…