Experienced CRA Germany - client dedicated

Syneos Health; Deutschland; On-site; EUR 55,000 - 75,000; Full time

Job summary

Syneos Health, Inc. in Germany seeks an Experienced CRA to monitor sites for client-dedicated trials. You will perform site qualification, initiation, interim monitoring and close-out visits (on-site or remote), ensuring regulatory, ICH-GCP and GPP compliance.

Responsibilities include confirmed consent verification, safeguarding confidentiality, and assessing subject safety and data integrity. You will conduct source document review, CRF verification, IP inventory, labeling and IP release per

Qualifications

• Experience with site qualification, initiation, monitoring and close-out visits.
• Knowledge of ICH-GCP guidelines and local regulations.
• Ability to verify informed consent and protect confidentiality.
• Experience with Source Data Review and CRF data verification.
• Experience with IP inventory, labeling and reconciliation.
• ISF and TMF reconciliation experience.
• Ability to communicate/escalate issues to project team.

Responsibilities

• Performs site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent process and protects confidentiality; assesses subject safety and data integrity.
• Per CMP/SMP: assesses site processes; conducts Source Document Review; verifies CRF data; resolves queries; supports data capture.
• May perform IP inventory, reconciliation and reviews storage and security; ensures proper labelling/release of IP.
• Routinely reviews ISF for accuracy; reconciles with TMF; ensures archiving per guidelines.
• Documents activities via letters and logs; supports recruitment and tracking of observations.
• For assigned activities, understands project scope, budgets, and timelines; adapts to changing priorities.
• May act as liaison with site personnel or with Central Monitoring Associate.

Skills

Site monitoring

ICH-GCP knowledge

GPP knowledge

Data entry / eCRF

IP inventory management

Job description

Experienced CRA Germany - client dedicated

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job 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 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. 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.
• For assigned activities, understands project scope, budgets, and timelines; 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 study site personnel, or in collaboration with Central Monitoring Associate.