Clinical Research Associate, Germany

This is a fully remote position, open to applicants in Germany.

📋 Description

• Conducts site qualification, initiation, interim monitoring, site management activities, and close-out visits (either on-site or remotely) ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and specific protocols.

• Utilizes judgment and experience to assess the overall performance of sites and site staff, providing recommendations for site-specific actions; promptly communicates/escalates serious issues to the project team and collaborates to develop action plans.

• Maintains an up-to-date understanding of ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company standard operating procedures (SOPs) and processes.

• Confirms that the process for obtaining informed consent has been properly executed and documented for each subject/patient, as necessary.

• Shows diligence in safeguarding the confidentiality of all subjects/patients.

• Evaluates factors that could impact the safety of subjects/patients and the integrity of clinical data at investigator/physician sites, such as protocol deviations/violations and pharmacovigilance concerns.

• Performs Source Document Review of relevant site source documents and medical records.

• Ensures that the clinical data recorded in the case report form (CRF) is accurate and complete.

• Employs query resolution techniques both remotely and on-site, offering guidance to site staff as needed, and drives query resolution to completion within agreed timelines.

• Confirms site adherence to electronic data capture requirements.

• Ensures that investigator/physician sites understand the necessity of archiving essential documents according to local guidelines and regulations.

• Aids in strategies for subject/patient recruitment, retention, and awareness.

• Must be capable of quickly adapting to changing priorities to meet goals/targets, with oversight from the Lead CRA.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field or a combination of education, training, and experience equivalent.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Experience in Real World Late Phase is advantageous.

• Must exhibit strong computer skills and be open to embracing new technologies.

• Exceptional communication, presentation, and interpersonal skills.

• Proficiency in German.

• Preferred location is North/Mid/West Germany.

• Ability to manage required travel of up to 75% regularly.

🏝️ Benefits

• We are committed to cultivating our employees through career development and progression;

• supportive and engaged line management;

• technical and therapeutic area training;

• peer recognition and total rewards program.

• We are dedicated to fostering an inclusive culture where you can truly be yourself.