Senior Clinical Research Associate

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

📋 Description

• Execute independent site monitoring tasks for clinical trials.

• Offer oversight, leadership, and guidance to CRA teams regarding scope, SOPs, timelines, budgets, compliance, and quality.

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

• Ensure prompt investigator site visits and facilitate cross-functional issue resolution.

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

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

• Generate precise monitoring visit reports detailing site issues, resolutions, protocol deviations, study progress, and enrollment.

• Confirm the integrity of source documents and CRF data.

• Execute quality control of eTMF/TMF documents and ensure investigational product accountability.

• Review regulatory binders and maintain communication with study sites regarding protocol and GCP compliance.

• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.

• Address data discrepancies with in-house CRAs, CTC, and data management.

• Identify site challenges, devise problem-solving strategies, and assist in audit preparation.

• Mentor CRAs and support CRA onboarding and training initiatives.

• Collaborate in the development and upkeep of the CTMS.

• Manage conflicting priorities and undertake additional assigned responsibilities.

⛳️ Requirements

• At least 4 years of clinical monitoring experience within the pharmaceutical, biotechnology, or CRO sectors.

• Ability to independently manage monitoring activities.

• Willingness to travel across Germany and Austria.

• Oncology experience is essential.

• Proficient command of the local language, both written and verbal, in the region where monitoring is conducted.

• Competent in English.

• Degree in a scientific health discipline.

• Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy.

• Familiarity with clinical research, ICH GCP, local regulations, regulatory, and ethical requirements.

• Strong computer skills, including proficiency in clinical trial management systems, clinical trial databases, and electronic data capture.

• Excellent organizational, analytical, negotiation, leadership, meeting management, and cross-functional team abilities.

• Capability to travel, manage stress, prioritize tasks, organize time, and resolve issues.

• Professional, reliable, disciplined, detail-oriented, and focused on quality.

• Outstanding communication and interpersonal skills.

• Ability to build and maintain positive relationships with sponsors, sites, and project team members.

🏝️ Benefits

• Flexible remote work arrangement.

• Standard employment contract.

• Opportunity for referrals.