Parexel is looking for a Senior Clinical Research Associate (Oncology Experience Preferred) to ensure data integrity, data quality, and compliance at the site level. In this role, you will conduct monitoring primarily virtually, with supplementary on-site visits, to ensure sites are protocol-compliant and prepared for inspection. We are a company driven by a shared goal to improve the world's health, doing our work with empathy and a commitment to putting patient well-being first.
What You'll Do
- Ensure regulatory, ICH-GCP, and protocol compliance at the site level.
- Evaluate site and site staff performance and provide recommendations for site-specific actions.
- Communicate and escalate significant issues to the project team and develop action plans.
- Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs.
- Verify the informed consent process has been adequately performed and documented for each subject.
- Assess factors affecting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
- Conduct monitoring activities via on-site and remote methods according to the Clinical Monitoring Plan.
- Perform source document review and verification of appropriate site source documents and medical records.
- Verify clinical data entered in the Case Report Form (CRF) is accurate and complete.
- Manage the reporting and follow-up of protocol deviations.
- Apply query resolution techniques remotely and on site, providing guidance to site staff.
- May perform Investigational Product (IP) inventory, reconciliation, and review storage and security.
- Verify IP has been dispensed and administered to subjects per protocol.
- Apply knowledge of GCP and local regulations to ensure IP is appropriately (re)labelled, imported, released, and returned.
- Manage reporting of identified issues and follow up to resolution.
- Document activities via follow-up letters, monitoring reports, communication logs, and other required documents.
- Ensure all activities are managed by appropriately delegated and trained site personnel.
- Enter data into tracking systems to track observations, status, and assigned action items to resolution.
- Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met.
- Review data entry timeliness, missing pages, outstanding data queries, and timelines for database locks.
- Review site signature sheet and delegation of duties log to confirm site staff documentation is appropriate and current.
- Conduct follow-up for escalated adverse event monitoring (AEM) report queries.
- Check that site and external facilities, equipment, and supplies remain adequate to conduct the trial.
- Check that site-specific logs are complete and up to date.
- Collaborate with the primary Site Manager, who acts as the primary liaison with site personnel.
- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings.
- Participate in global clinical monitoring and project staff meetings and attend clinic.
What We're Looking For
- Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training, and experience.
- Proficiency in the local language (French) is required.
- Advanced level or fluency in English is required.
- Demonstrated networking and relationship-building skills.
- Ability to communicate effectively and appropriately with internal and external stakeholders.
- Ability to adapt to changing technologies and processes.
- Excellent communication (verbal and written), presentation, and interpersonal skills.
- Proven ability to identify and build effective relationships with investigator site staff and other stakeholders.
Nice to Have
- Oncology experience.
Team & Environment
You will collaborate with a primary Site Manager who acts as the main liaison with site personnel.
Work Mode
This is a remote position based in the Paris Region, France.
Parexel is an equal opportunity employer.
