CRA II - multi-sponsor (north-east Germany)

CRA Germany – multi‑sponsor (north‑east Germany)

We are looking for an experienced Clinical Research Associate (CRA) to join our team in Germany.

The CRA will perform site qualification, initiation, monitoring, management, and close‑out activities, ensuring compliance with regulatory, ICH‑GCP, and company SOPs.

• Job Responsibilities
• Perform 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.

Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.

• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

Demonstrate diligence in protecting the confidentiality of each subject/patient.

Assess 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.

• Assess site processes and conduct Source Document Review of appropriate site source documents and medical records.

Verify required clinical data entered in the case report form (CRF) is accurate and complete.

Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

• May perform investigational product (IP) inventory, reconciliation and reviews of storage and security.

Verify the IP has been dispensed and administered to subjects/patients according to the protocol.

Verify issues or risks associated with blinded or randomized information related to IP.

• Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness.

Reconcile contents of the ISF with the Trial Master File (TMF).

Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with 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 Clinical Monitoring Plan/Site Management Plan.

Support subject/patient recruitment, retention and awareness strategies.

Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

• For assigned activities, understand project scope, budgets, and timelines; manage site‑level activities/communication to ensure project objectives, deliverables and timelines are met.

Adapt quickly to changing priorities to achieve goals/targets.

• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate, ensuring 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 in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements.

• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow‑up actions.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.

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
• At least two years of monitoring experience
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Fluency in German and English
• Preferably located in north‑east Germany and able to manage required travel of up to 75% on a regular basis; monitoring across the DACH region might be required
• Summary

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location.

This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols, utilizing data analytics and risk‑based monitoring techniques to identify potential issues and trends, and collaborating with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.

Additional

Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive.

The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract.

The Company is committed to compliance with applicable laws and equal opportunity employment.

The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations as appropriate.

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