CRA Germany or Austria - single-client

Updated: Yesterday
Location: DEU-Remote
Job ID:

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.

Why Syneos Health

WORK HERE MATTERS EVERYWHERE

• 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 continuously build the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures and perspectives, we create a place where everyone feels they belong.

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.
• 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.
• 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, and verifies issues or risks associated with blinded or randomized information related to IP.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciles contents of the ISF with the Trial Master File (TMF), and 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, and 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, ensuring all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions.

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.
• Previous monitoring experience in Germany.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Fluency in both German and English.
• Ability to manage required travel for monitoring visits.

Equal 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, please contact us at

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