Senior Clinical Research Associate

This is a fully remote position, open to applicants in France.

📋 Description

• Function as an integral member of a Project Team in an operational capacity.

• Initiate, oversee on-site and remote activities, and conclude clinical study sites.

• Monitor clinical trials in accordance with company and sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) guidelines, and regulatory mandates.

• Conduct monitoring activities to evaluate subject safety, data integrity, and overall quality.

• Confirm adherence to informed consent processes and protocol compliance.

• Review both electronic and paper Case Report Forms (CRFs) and subject source documents.

• Ensure appropriate management and accountability of Investigational Products.

• Prepare Monitoring Visit Reports, document findings along with corrective and preventive actions, update tracking systems, and escalate any issues.

• Communicate identified issues and necessary action items to study sites.

• Submit site documents to the electronic Trial Master File (eTMF) or paper Trial Master File (TMF) and verify the maintenance of the Investigator Site File.

• Engage in audit and inspection preparation and follow-up activities.

• Order, ship, and reconcile clinical investigative supplies as needed.

• Maintain accurate site-level information in Clinical Trial Management Systems (CTMS) and project systems.

• Devote efforts to a single global pharmaceutical or biotechnology sponsor.

⛳️ Requirements

• Bachelor’s degree, preferably in life sciences or nursing, or an equivalent qualification.

• A minimum of 3 years of experience in oncology monitoring.

• At least 1 year of experience in Phase I/II oncology studies.

• Strong knowledge of GCP/ICH standards.

• Proficiency in English.

• Capability to thrive in a fast-paced environment with shifting priorities.

• Ability to work autonomously as well as collaboratively within a matrix organization.

• Excellent written and verbal communication skills.

• Strong organizational abilities.

• Proficient in technology with solid software and computer skills.

• Attributes such as self-awareness, determination, flexibility, proactivity, a collaborative mindset, an analytical approach, and keen attention to detail.

• Willingness and ability to travel up to 60-80% of the time.

🏝️ Benefits

• Opportunities for both personal and professional advancement.

• A fulfilling work environment.

• Team culture focused on collaboration.

• Commitment to quality within the workplace culture.

• Chance to positively impact patients' lives.

• Flexible solutions for clinical development and strategic resourcing.