CRA Germany - Berlin/Leipzig/Dresden

Syneos Health; Deutschland; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Syneos Health in Germany seeks an experienced Clinical Research Associate to join our team across Berlin, Leipzig and Dresden. You will perform site qualification, initiation, interim monitoring and close-out visits, ensuring regulatory and ICH-GCP compliance.

You will verify informed consent, protect patient confidentiality, assess safety and data integrity, and support ISF/TMF reconciliation, data query resolution and IP handling.

Qualifikationen

• Experience as a Clinical Research Associate with site monitoring responsibilities.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• Ability to work with cross-functional teams and manage documentation.

Aufgaben

• Performs site qualification, initiation, interim monitoring and close-out visits.
• Ensures regulatory compliance and ICH-GCP adherence; communicates issues to project team and develops action plans.
• Verifies informed consent and protects patient confidentiality; assesses safety and data integrity.
• Reconciles Investigator Site File (ISF) with Trial Master File (TMF); manages source data review and queries.
• Documents activities via letters, reports and logs; supports subject recruitment and data tracking.
• Understands project scope, budgets and timelines; adapts to changing priorities.

Jobbeschreibung

CRA Germany - Berlin/Leipzig/Dresden

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

For one of our clients we are currently looking for an experienced CRA to join the team in the Northeastern region.

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