Senior Clinical Research Associate (Oncology Experience Preferred) - Paris Region, France (Remo[...]

Parexel; Paris; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading clinical research organization in Paris is seeking a Senior Clinical Research Associate. This role involves ensuring data integrity and compliance with regulatory standards while conducting monitoring activities, both remotely and on-site. Ideal candidates will have a strong background in clinical research, a commitment to patient well-being, and a Bachelor’s degree or equivalent experience.

Qualifications

• Proven experience in clinical research monitoring.
• Knowledge of ICH GCP and local regulatory requirements.
• Ability to perform on-site and remote monitoring.

Responsabilités

• Ensure data integrity and compliance with regulations.
• Conduct monitoring activities as per the Clinical Monitoring Plan.
• Collaborate with Site Manager for site readiness and inspections.

Connaissances

Networking

Relationship-building

Effective communication

Adaptability to new technologies

Proficiency in local language

Proficiency in English

Formation

Bachelor’s degree or RN in a related field

Description du poste

When our values align, there's no limit to what we can achieve.

Parexel is currently recruiting for a sponsor-dedicated Senior Clinical Research Associate based in the Paris region, France.

The Senior CRA will be responsible for ensuring data integrity, data quality, and compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will mostly be performed virtually to supplement on-site visits. The Site Monitor II will collaborate with the Site Manager to ensure site compliance with the protocol and readiness for inspections, and will coordinate with institutions and investigators at the local level.

Some specifics about this advertised role

Ensuring regulatory, ICH-GCP, and protocol compliance. Uses judgment and experience to evaluate overall site performance and provide recommendations; communicates significant issues to the project team and develops action plans. Maintains knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

Verifies that informed consent has been obtained and documented appropriately for each subject.

Protects subject confidentiality and assesses factors affecting subject safety and data integrity, such as protocol deviations and pharmacovigilance issues.

Conducts monitoring activities using on-site and remote methods as permitted by country regulations, per the Clinical Monitoring Plan (CMP) or SMP.

Performs source document review, verifies data accuracy in CRFs, and manages protocol deviations and follow-up actions.

Applies query resolution techniques remotely and on-site, guiding site staff to resolve queries within timelines.

May perform Investigational Product (IP) inventory, reconciliation, and storage reviews.

Verifies IP dispensing and administration, ensuring compliance with the protocol and proper handling of blinded or randomized information.

Ensures proper labeling, importation, release, and return of IP according to GCP, local regulations, and SOPs.

Documents activities via reports, logs, and communication records, ensuring all activities are managed by trained site personnel.

Enters data into tracking systems, manages site activities, and communicates to meet project objectives and timelines, adapting to changing priorities.

Reviews data entry timeliness, missing data, queries, and database lock timelines.

Reviews site signature sheets and delegation logs, and assesses training compliance for site staff.

Follows up on escalated adverse event reports and monitors site and external facilities for adequacy and expiry dates.

Ensures site logs are complete and up-to-date.

Collaborates with the primary Site Manager and participates in meetings and site visits.

Who are Parexel?

Parexel supports clinical studies across various therapeutic areas, partnering with a broad client base. We have contributed to trials for many top-selling drugs and niche developments vital to patient well-being.

You will be an integral part of our team.

What we are looking for in this role

We seek professionals committed to putting patient well-being first, working with heart.

Skills

Networking, relationship-building, effective communication, adaptability to new technologies, and proficiency in local language and English.

Education

Bachelor’s degree or RN in a related field, or equivalent experience.