Senior Clinical Research Associate

This is a fully remote position, open to applicants in Netherlands, +1 more country.

📋 Description

• Independently conduct site monitoring duties for clinical trials.

• Provide leadership, oversight, and guidance to Clinical Research Associate (CRA) teams.

• Ensure compliance with project scope, standard operating procedures (SOPs), timelines, budgets, protocols, Good Clinical Practice (GCP), and regulatory requirements.

• Review monitoring visit reports and carry out co-monitoring and evaluation visits.

• Ensure timely visits to investigator sites.

• Coordinate cross-functional resolutions for issues arising during clinical trial monitoring.

• Assist in the preparation of Monitoring Plans, training presentations, ethics documentation, and site contract negotiations.

• Provide monthly billing details to the finance department.

• Oversee study budgets and serve as the sponsor contact for standalone projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and onsite.

• Prepare detailed monitoring visit reports that address site issues, resolutions, protocol deviations, study progress, and enrollment status.

• Verify the integrity of source documents and Case Report Form (CRF) data.

• Conduct quality control checks of electronic Trial Master File (eTMF)/Trial Master File (TMF) documents and ensure accountability of investigational products.

• Review regulatory binders at the site level.

• Maintain contact with sites, evaluate patient accrual, and respond to requests from sponsors.

• Facilitate the reporting of adverse events and reconciliation of Serious Adverse Events (SAEs).

• Resolve data discrepancies in collaboration with in-house CRAs, Clinical Trial Coordinators (CTC), and data management teams.

• Identify site-related issues and formulate problem-solving strategies.

• Prepare study sites for audits.

• Mentor and train CRAs, including onboarding for new hires.

• Collaborate on the development and maintenance of Clinical Trial Management Systems (CTMS).

• Manage competing priorities and undertake additional assigned responsibilities.

⛳️ Requirements

• At least 3 years of experience in clinical monitoring within the pharmaceutical, biotechnology, or Contract Research Organization (CRO) industry.

• Capability to independently manage monitoring activities.

• Experience in oncology.

• Willingness to travel within Belgium and the Netherlands.

• Quality-oriented with a meticulous, thorough, and detail-focused approach.

• Strong organizational abilities and adeptness at multitasking in a dynamic environment.

• Proficiency in managing priorities, organizing time effectively, and resolving issues.

• Excellent analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills.

• Ability to travel and handle stress effectively.

• Professional, reliable, and self-disciplined.

• Proficient in addressing unstructured or ambiguous challenges.

• Strong command of the local language, both written and verbal, in the country where monitoring activities are conducted.

• Outstanding communication and interpersonal skills with a customer service focus.

• Proficient in computer skills, including familiarity with clinical trial management systems, clinical trial databases, and electronic data capture tools.

• Knowledgeable about clinical research, ICH GCP guidelines, and local regulations.

• Understanding of regulatory and ethical requirements.

• Ability to foster and maintain positive relationships with sponsors, site personnel, and project team members.

• Degree in a scientific health-related field.

• Adequate proficiency in English.

• Bachelor’s degree in Biology, Biotechnology, Life Sciences, Pharmacy, or a related scientific health discipline.

🏝️ Benefits

• Opportunity for remote work.

• Regular employment contract.