Clinical Research Associate – FSP

Clinical Research Associate – FSP

Company: Parexel Location: Netherlands Work Model: Hybrid Contract: Permanent

At Parexel, we are united by a shared mission: to improve global health. Our work, from clinical trials to regulatory affairs and consulting, is driven by a deep commitment to making a difference in patients' lives. We approach our roles with empathy and a dedication to excellence.

About the Role

As a Clinical Research Associate (CRA) within our Functional Service Provider (FSP) model, you will play a crucial role in the successful execution of clinical studies. You will be responsible for ensuring that studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP guidelines, and applicable regulations.

Key Responsibilities

• Contribute to investigator selection and site initiation.
• Manage study start-up activities, including the collection, review, and submission of essential documents to ethics committees and regulatory authorities.
• Train, support, and advise investigators and site staff on study-related matters, including Risk-Based Quality Management (RbQM) principles.
• Ensure site staff are adequately trained, including ICH-GCP, and that sites are inspection-ready at all times.
• Participate in Local Study Team (LST) and National Investigator meetings.
• Initiate, monitor, and close study sites in compliance with client procedures.
• Monitor site progress, including patient recruitment, quality, and performance.
• Proactively identify and resolve study-related issues, escalating as necessary.
• Maintain and update clinical trial management systems (CTMS) and other relevant databases.
• Manage study supplies, including investigational product accountability and destruction.
• Conduct remote and onsite monitoring visits according to the Monitoring Plan.
• Perform Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV).
• Conduct Site Quality Risk Assessments and adapt monitoring intensity.
• Ensure timely resolution of data queries and maintain the quality of collected study data.
• Ensure accurate and timely reporting of Serious Adverse Events (SAEs).
• Prepare and finalize monitoring visit reports and follow-up letters.
• Escalate quality issues, data privacy breaches, or compliance concerns as required.
• Assist sites in maintaining their Investigator Site Files (ISF) and ensure timely uploading of essential documents into the electronic Trial Master File (eTMF).
• Collaborate with teams during audits and regulatory inspections.
• Provide feedback on research-related information relevant to the local market.
• Ensure compliance with company policies, ethical standards, and local legislation.

Requirements

Essential:

• Bachelor's degree in a related discipline, preferably in life sciences, or equivalent qualification.
• Excellent knowledge of ICH-GCP guidelines and basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Solid medical knowledge and the ability to learn therapeutic areas.
• Basic understanding of the drug development process.
• Good understanding of clinical study management, including monitoring, drug handling, and data management.
• Excellent attention to detail.
• Strong written and verbal communication skills.
• Effective collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license (may be adapted to local country needs).

Desirable:

• Experience working with remote collaborators.
• Ability to manage change effectively and embrace new processes.
• A proactive approach to identifying and implementing more efficient and effective trial delivery methods.
• Good analytical and problem-solving skills.
• Demonstrated ability to prioritize and manage multiple tasks with conflicting deadlines.
• Familiarity with risk-based monitoring and remote monitoring approaches.
• Good cultural awareness.
• Ability to leverage technology and computer skills effectively.
• Team-oriented and flexible with the ability to adapt to changing demands.

What We Offer

Join Parexel and become part of a team dedicated to advancing healthcare worldwide. We offer a dynamic work environment where your contributions are valued, and you will have opportunities for professional growth and development.