Sponsor-dedicated CRA I (mix with Project Assistant) - Warsaw, hybrid role

Updated: Yesterday

Location: POL-Warsaw-Hybrid

Job ID:25101936

Description

Sponsor-dedicated CRA I (mix with Project Assistant) - Warsaw, hybrid role

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

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment to evaluate site performance and provides recommendations to the project team; communicates/escalates serious issues and develops action plans with guidance. Maintains knowledge of ICH/GCP Guidelines, applicable regulations, and company SOPs/processes.
• Verifies informed consent processes and documentation; protects subject confidentiality. Assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations, pharmacovigilance issues).
• For CMP/SMP: assesses site processes; conducts source document review; verifies accuracy and completeness of data in CRFs; applies remote and on-site query resolution; supports data capture and ensures compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and storage/security reviews. Verifies IP dispensing and administration per protocol; manages labeling, import/export and release/return in accordance with GCP/local regulations.
• Routinely reviews Investigator Site File (ISF) for accuracy and completeness; reconciles with Trial Master File (TMF). Ensures archiving of essential documents per local guidelines and regulations.
• Documents activities via letters, reports, logs, and other required project documents; supports subject recruitment and retention; enters data into tracking systems to monitor observations and action items.
• Understands project scope, budgets, and timelines; manages site-level activity and communication to meet objectives. Adapts to changing priorities with oversight from Lead CRA.
• May act as primary liaison with site personnel or with other CRAs/CMA; ensures training and compliance of site staff with applicable requirements.
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and attends clinical training as required.
• Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
• For Real World Late Phase, the CRA I uses the business card title Site Management Associate I with responsibilities including: site support across the study lifecycle, knowledge of local requirements for real-world late-phase designs, chart abstraction, data collection, and collaboration with Sponsor affiliates and local 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 regulatory requirements
• Strong computer skills and ability to adapt to new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
• US ONLY: As part of employment, you may be deployed to Sites requiring personal information for facility access. Compliance with the Site requests is a condition of employment; failure to provide information may affect entry.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The Company will determine what constitutes an equivalent qualification. This description does not create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations when appropriate.

Summary

Roles within Clinical Monitoring/CRA involve monitoring data and processes to ensure trial integrity, including remote monitoring, data analytics, and risk-based monitoring. Collaboration with site teams to improve quality monitoring and support trial success. Entry to developing individual contributor, capable of directing small projects and teams.

Syneos Health is an Equal Opportunity Employer. If your past experience doesn’t align perfectly, we encourage you to apply anyway and join our Talent Network to stay connected to opportunities.

Syneos Health (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We support a diverse, equitable and inclusive culture.

Phone: 919 876 9300

Fax: 919 876 9360

Toll-Free: 866 462 7373

Contact: jobs@syneoshealth.com