CRA

Upsilon Global; Deutschland; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Upsilon Global are supporting the growth of an established Global CRO with a strong scientific focus and an expanding clinical research portfolio across Europe. This is an exciting opportunity for an experienced Senior Clinical Research Associate to join a growing clinical operations team on a permanent basis, contributing to the successful delivery of clinical studies across Germany and internationally.

The primary requirements are strong clinical research experience, a thorough understanding

Qualifikationen

• Minimum of 2 years' experience as a Clinical Research Associate.
• Strong knowledge of ICH-GCP and clinical trial regulations.
• Experience conducting monitoring visits across multiple clinical trial sites.
• Experience with interventional clinical trials and investigational medicinal products.
• Ability to travel regularly within Germany.

Aufgaben

• Conduct Site Selection Visits, Site Initiation Visits, Monitoring Visits and Close-Out Visits.
• Monitor clinical trial sites in accordance with the study protocol, sponsor requirements, ICH-GCP and applicable regulations.
• Conduct Source Data Verification (SDV) and Source Data Review (SDR) to ensure data quality and accuracy.
• Review informed consent documentation and ensure patient safety and subject protection are maintained.
• Identify, document and follow up on protocol deviations, site issues and other study-related risks.
• Support investigators and site staff with study-related questions and provide guidance on protocol requirements.
• Maintain effective communication with investigators, study coordinators, sponsors and internal study teams.
• Prepare accurate, high-quality monitoring reports within required timelines.
• Ensure essential regulatory and study documentation is complete, accurate and inspection ready.
• Contribute to risk-based monitoring activities and overall study quality oversight.
• Support study start-up, recruitment, study maintenance and close-out activities.
• Participate in investigator meetings, study team meetings and relevant training activities.
• Monitor site performance and ensure study activities are completed in accordance with agreed timelines.
• Support the resolution of queries and ensure timely follow-up of outstanding actions.
• Ensure appropriate storage, accountability and reconciliation of investigational medicinal products and study materials.
• Review the completeness of CRFs, Investigator Site Files and other essential study documentation.
• Support regulatory submissions and approvals in collaboration with study start-up and site teams.
• Assist with the resolution of audit findings and implementation of corrective actions where required.
• Ensure adverse events and serious adverse events are appropriately documented and followed up.
• Support the reconciliation and close-out of study materials, documentation and site activities at the end of a trial.

Kenntnisse

ICH-GCP

Site Monitoring

SDV/SDR

Regulatory Compliance

Stakeholder Management

Ausbildung

Bachelor's or Master's degree in Life Sciences

Tools

Veeva

Medidata RAVE

Oracle

MS Projects

Jobbeschreibung

Upsilon Global are supporting the growth of an established Global CRO with a strong scientific focus and an expanding clinical research portfolio across Europe.

The organisation delivers high-quality clinical trials across a range of therapeutic areas, combining scientific expertise with strong operational delivery and close collaboration across international study teams.

This is an exciting opportunity for an experienced Senior Clinical Research Associate to join a growing clinical operations team on a permanent basis, contributing to the successful delivery of clinical studies across Germany and internationally.

The primary requirements are strong clinical research experience, a thorough understanding of ICH-GCP, excellent organisational skills, and the ability to build effective relationships with investigators and site teams.

The portfolio spans a range of therapeutic areas, with experience across areas such as CNS, cardio-metabolic, renal, rare diseases, infectious diseases and vaccines being beneficial.

This is a fantastic opportunity for a SCRA looking to join an international clinical research organisation where they can take ownership of their work, collaborate with experienced study teams, and continue developing their career within a growing environment.

• Start Date: November
• Contract Type: Permanent
• Company Type: Global CRO
• Location: Germany
• Language Requirements: German and English
• Travel: Regular travel within Germany, with occasional international travel

Key Responsibilities:

• Conduct Site Selection Visits, Site Initiation Visits, Monitoring Visits and Close-Out Visits.
• Monitor clinical trial sites in accordance with the study protocol, sponsor requirements, ICH-GCP and applicable regulations.
• Conduct Source Data Verification (SDV) and Source Data Review (SDR) to ensure data quality and accuracy.
• Review informed consent documentation and ensure patient safety and subject protection are maintained.
• Identify, document and follow up on protocol deviations, site issues and other study-related risks.
• Support investigators and site staff with study-related questions and provide guidance on protocol requirements.
• Maintain effective communication with investigators, study coordinators, sponsors and internal study teams.
• Prepare accurate, high-quality monitoring reports within required timelines.
• Ensure essential regulatory and study documentation is complete, accurate and inspection ready.
• Contribute to risk-based monitoring activities and overall study quality oversight.
• Support study start-up, recruitment, study maintenance and close-out activities.
• Participate in investigator meetings, study team meetings and relevant training activities.
• Monitor site performance and ensure study activities are completed in accordance with agreed timelines.
• Support the resolution of queries and ensure timely follow-up of outstanding actions.
• Ensure appropriate storage, accountability and reconciliation of investigational medicinal products and study materials.
• Review the completeness of CRFs, Investigator Site Files and other essential study documentation.
• Support regulatory submissions and approvals in collaboration with study start-up and site teams.
• Assist with the resolution of audit findings and implementation of corrective actions where required.
• Ensure adverse events and serious adverse events are appropriately documented and followed up.
• Support the reconciliation and close-out of study materials, documentation and site activities at the end of a trial.

Requirements:

• Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, Biomedical Sciences or a related discipline.
• Minimum of 2 years' experience working as a Clinical Research Associate within clinical trials.
• Strong knowledge of ICH-GCP, clinical trial regulations and monitoring practices.
• Experience conducting independent monitoring visits across multiple clinical trial sites.
• Experience with interventional clinical trials and investigational medicinal products.
• Strong understanding of clinical trial processes from study start-up through to close-out.
• Excellent organisational skills and the ability to manage multiple priorities effectively.
• Strong problem-solving ability and a proactive approach to identifying and resolving issues.
• High attention to detail and a consistent focus on quality.
• Ability to work independently while contributing effectively within an international study team.
• Additional Skills
• Fluency in German and English, both written and spoken.
• Currently residing in Germany.
• Willingness and ability to travel regularly within Germany and occasionally internationally.
• Strong verbal and written communication skills.
• Excellent interpersonal and relationship-building skills.
• Flexible and adaptable approach to working in a dynamic clinical research environment.
• Strong client-focused mindset and commitment to delivering high-quality work within agreed timelines.
• Proficiency in Microsoft Office and the ability to learn and work effectively with clinical research systems and software.
• Ability to collaborate effectively with colleagues and stakeholders across different countries and cultures.
• Excellent verbal and written communication skills.
• Good understanding of applicable guidelines governing clinical trials.
• Proficient in clinical data management tools (Veeva, Oracle, Medidata RAVE), Microsoft Office (Word, Excel, PowerPoint), and MS Projects.
• Ability to manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate as per timelines.
• Ability to contribute to developing clinical protocols, informed consent forms, and case report forms.
• Problem-solving skills with the ability to identify, assess and resolve site performance, quality, or compliance problems.
• Exceptional interpersonal skills to develop strong site relationships through all trial phases.

Why This Opportunity?

• This is an opportunity to join an international clinical research organisation with a broad therapeutic portfolio and the stability of a permanent position. You will work alongside experienced clinical research professionals, take ownership of your sites and studies, and have the opportunity to build your experience across a diverse range of clinical trials.