Clinical Research Associate (Site Monitoring) - 21390

Clinical Research Associate (Site Monitoring)

Contract  |  Netherlands  |  Sponsor-dedicated, field-based
 

Location: Netherlands - resident, with travel to three trial sites

Sites: Two established adult surgical centers and one pediatric site in start-up

Engagement: Contract, field-based; ongoing with growing scope through 2027

Cadence: On-site monitoring visits approximately every 4-6 weeks per site, plus in-house site management between visits

Reports to: Sponsor's internal clinical monitoring team

Immediate priority: Support clean, inspection-ready data to Database Lock and EU regulatory submission

We are a U.S.-headquartered, clinical-stage pharmaceutical company developing a novel portfolio of imaging drugs for optical surgical navigation and targeted therapies for hard-to-treat cancers. Our lead imaging program is in a global, multi-site pivotal Phase 3 trial and is advancing toward EU regulatory submission. We work hand-in-hand with leading surgical and oncology centers to bring first-in-class technology into the operating room and improve patient outcomes.

This role exists to protect the quality and integrity of our clinical trial data at the Netherlands sites during a pivotal, time-critical stage of the program. In the immediate term, you will help ensure clean, complete, inspection-ready data as we drive toward Database Lock and EU regulatory submission. You will cover three NL sites: two established adult surgical centers that have supported the program for nearly three years, and a pediatric surgical site now in start-up.

The role is built to grow. As we transition monitoring and oversight in-house from our CRO, you will step in as the sponsor's responsible CRA for these sites, reporting directly to our internal clinical monitoring team rather than a CRO. Across 2026 and 2027 the scope expands through a new study phase, the pediatric surgical study, and an additional Phase 3 program - a stable, long-term engagement with genuine ownership of your sites.

Site Monitoring & Sponsor Oversight

• →Conduct on-site monitoring visits at the assigned NL sites on an approximately 4-6 week cadence (currently monthly at the adult sites), with in-house site management between visits.
• →Perform source data review and verification to confirm data quality, integrity, and protocol compliance.
• →Support intensive data cleaning and query resolution to meet Database Lock timelines for the pivotal study.
• →As monitoring transitions from the CRO, serve as the sponsor's responsible CRA for the assigned sites, reporting to the internal clinical monitoring team.

Site Start-Up & Close-Out

• →Support start-up and initiation of the pediatric surgical site, including site qualification, training, and readiness.
• →Assess site staff experience, GCP knowledge, and understanding of protocol requirements at qualification.
• →Manage close-out activities, including Investigational Product (IP) reconciliation, data review for database lock, and reconciliation of trial master and site files.

Trial Documentation & Data Management

• →Maintain accurate, current trial documentation, including the trial master file (TMF), site files, and correspondence with sites and authorities.
• →Keep study systems and trackers (EDC, CTMS, dashboards) current; drive timely, accurate data collection and query resolution.

Quality, Compliance & Inspection Readiness

• →Ensure ongoing compliance with ICH-GCP, SOPs, and applicable EU and NL regulatory requirements throughout the conduct of the trial.
• →Support inspection readiness, pre-inspection activities, and responses during site audits and regulatory inspections, in support of EU submission.

Communication & Transition

• →Serve as the sponsor's primary contact for assigned sites, providing ongoing training and study updates.
• →Coordinate a smooth handover of monitoring responsibilities from the CRO to the sponsor.
• →Facilitate clear communication among sites, sponsor, and vendors, and escalate issues promptly and appropriately.

• Bachelor's degree in a life-sciences or relevant scientific discipline (or at least 5 years of clinical research monitoring experience in lieu of a degree).
• Minimum 2 years of CRA experience including independent, multi-site monitoring (4+ years and sponsor-side experience strongly preferred - see below).
• Working knowledge of ICH-GCP (ICH-E6) and applicable clinical trial regulations and procedural documents.
• Hands-on experience with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).
• Current GCP certification.
• Resident in the Netherlands, with the ability to travel to all three sites for on-site visits.
• Proven ability to work autonomously, manage competing priorities, and protect data quality under aggressive timelines.
• Strong critical-thinking and root-cause analysis, with clear communication with medical and scientific site staff.

• Experience monitoring drug-device combination or imaging-agent trials; familiarity with ISO-14155. Imaging experience is a strong plus.
• 4+ years of monitoring experience; sponsor-dedicated or CRO-oversight background, and experience transitioning site oversight from a CRO to a sponsor.
• Pediatric clinical trial monitoring experience.
• Dutch language proficiency, including reading medical source documents (a portion of source records are in Dutch; the majority are in English).
• Familiarity with the EU Clinical Trials Regulation (CTR) / CTIS and Netherlands regulatory and ethics processes (CCMO / METC).
• Surgical or oncology trial experience; Phase 3 / pivotal trial experience.

You are a self-directed, experienced monitor who can own sites end to end and operate as the sponsor's responsible CRA without close oversight. You are energized by aggressive timelines, meticulous with source data, and calm under inspection-level scrutiny. You can step into an established, high-enrolling program, absorb its history quickly, and keep data clean under deadline pressure, while helping stand up a new pediatric site and managing a smooth handover from a CRO. You raise issues early, drive them to closure, and treat data integrity and patient safety as non-negotiable.