Clinical Research Associate (CRA) Germany

Syneos Health, Inc.; Germany (OH); On-site; USD 56,766 - 79,473; Full time

Job summary

Syneos Health, Inc. is seeking a Clinical Research Associate (CRA) in Germany, focusing on site qualification, monitoring, and management. The ideal candidate will have a Bachelor’s degree or relevant RN qualification, experience in clinical settings, and fluency in German.

This role allows remote work while ensuring compliance with Good Clinical Practice (GCP) regulations. Responsibilities include managing site activities and ensuring participant safety throughout clinical trials. A commitment to travel up to 75% is expected.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Experience in Real World Late Phase would be a plus.
• Fluency in German.

Responsibilities

• Perform site monitoring and management activities ensuring protocol compliance.
• Document activities via confirmation letters, reports, and communication logs.
• Act as primary liaison with project site personnel.

Skills

Good Clinical Practice/ICH Guidelines

Fluency in German

Excellent communication skills

Computer skills

Education

Bachelor's degree or RN in a related field

Job description

Clinical Research Associate (CRA) Germany

Updated: Yesterday
Location: DEU-Remote
Job ID:25109631

Clinical Research Associate (CRA) Germany

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 Pharmacoepidemiological Practices (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, with guidance, develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies that 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.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP):
• Assess site processes
• 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
• Utilize available hardware and software to support the effective conduct of the clinical project data review and capture
• Verify site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews of 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 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 and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals/targets.
• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). 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 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.
• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:
• Site support throughout the study lifecycle from site identification through close‑out
• Knowledge of local requirements for real world late phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff

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 in Real World Late Phase would be a plus
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Fluency in German
• Preferable location is North/Mid/West Germany
• Ability to manage required travel of up to 75% on a regular basis

Equal Employment Opportunity Statement:

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: [e-mail]. One of our staff members will work with you to provide alternate means to submit your application.