Senior Clinical Research Associate

KlinEra Global Services; Deutschland; On-site; EUR 65,000 - 95,000; Full time

Job summary

KlinEra Global Services seeks an experienced Senior Clinical Research Associate (CRA) with a strong oncology focus to support monitoring activities across Germany. You will ensure adherence to ICH-GCP, EU regulations, and local German requirements, while safeguarding patient safety and data integrity.

The role includes site initiation visits, SDV/SDR, patient recruitment oversight, safety reporting, and collaboration with investigators and cross-functional teams.

Qualifications

• Bachelor's degree or higher in Life Sciences, Pharmacy, Nursing, or a related discipline.
• Minimum 5 years of clinical research monitoring experience, preferably as a CRA.
• Proven experience monitoring oncology clinical trials.
• Strong knowledge of ICH-GCP, clinical trial regulations, and risk-based monitoring principles.
• Fluent in German and proficient in English, both written and spoken.
• Must currently reside in Germany and be eligible to work in Germany.
• Experience with EDC systems, electronic Trial Master File (eTMF) platforms, and clinical trial management systems (CTMS).
• Excellent communication, organizational, problem-solving, and site management skills.
• Ability to work independently and manage multiple clinical trial sites.

Responsibilities

• Conduct site selection, initiation, monitoring and close-out visits for oncology trials.
• Monitor sites for protocol and regulatory compliance (ICH-GCP, EU CTR, German requirements).
• Perform SDV, SDR, and review essential trial documentation.
• Oversee patient recruitment, informed consent, eligibility verification, and protocol adherence.
• Review AEs/SAEs and safety reporting with investigators and study teams.
• Identify and follow up on protocol deviations and data discrepancies.
• Maintain monitoring visit reports and trial documentation within timelines.
• Collaborate with investigators, site staff, CTMs, and cross-functional teams.
• Support site readiness, inspections, and resolution of findings.
• Travel across Germany to trial sites as required.

Skills

Oncology monitoring

Site management

EDC systems

eTMF platforms

CTMS

German & English fluency

Communication skills

Education

Bachelor's degree in Life Sciences/related

Tools

EDC systems

eTMF platforms

CTMS

Job description

Location: Germany (Candidates must be based in Germany)

Position Type: Full-Time / Contract

Therapeutic Area: Oncology

Language Requirements: Fluent German and English

Position Overview

KlinEra Global Services is seeking an experienced Senior Clinical Research Associate (CRA) with a strong background in oncology clinical trials to support clinical trial monitoring activities across Germany. The successful candidate will ensure compliance with the clinical trial protocol, ICH-GCP guidelines, applicable EU regulations, and local regulatory requirements while maintaining high standards of patient safety, data integrity, and site quality.

Key Responsibilities

• Conduct site selection, site initiation, interim monitoring, and close-out visits for oncology clinical trials.
• Monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP, applicable EU Clinical Trials Regulation, and relevant German requirements.
• Perform source data verification (SDV), source data review (SDR), and review of essential study documentation.
• Oversee patient recruitment, informed consent, eligibility verification, and protocol compliance.
• Review adverse events (AEs), serious adverse events (SAEs), and safety reporting documentation in collaboration with investigators and study teams.
• Identify, document, and follow up on protocol deviations, data discrepancies, and site compliance issues.
• Maintain accurate monitoring visit reports, follow-up letters, and trial documentation within the applicable timelines.
• Collaborate with investigators, site staff, Clinical Trial Managers, and cross-functional study teams.
• Support site readiness, inspection preparedness, and resolution of monitoring findings.
• Travel to clinical trial sites across Germany as required.

Required Qualifications and Experience

• Bachelor's degree or higher in Life Sciences, Pharmacy, Nursing, or a related discipline.
• Minimum 5 years of clinical research monitoring experience, preferably as a CRA.
• Proven experience monitoring oncology clinical trials.
• Strong knowledge of ICH-GCP, clinical trial regulations, and risk-based monitoring principles.
• Fluent in German and proficient in English, both written and spoken.
• Must currently reside in Germany and be eligible to work in Germany.
• Experience with EDC systems, electronic Trial Master File (eTMF) platforms, and clinical trial management systems (CTMS).
• Excellent communication, organizational, problem-solving, and site management skills.
• Ability to work independently and manage multiple clinical trial sites.

Preferred Qualifications

• Experience with Phase I to Phase III oncology studies.
• Familiarity with EU Clinical Trials Information System (CTIS) and applicable German ethics committee and regulatory processes.
• Experience with complex oncology protocols, including investigational medicinal products and safety oversight.
• Previous experience working with international CROs or pharmaceutical sponsors.

What We Offer

• Opportunity to contribute to oncology clinical trials with an international clinical research organization.
• Collaboration with experienced clinical operations and global study teams.
• Professional engagement in a dynamic, quality-focused clinical research environment.