Oncology Clinical Research Coordinator (Contract / Onsite / Munich)

POSITION SUMMARY

Experienced Clinical Research Coordinator (CRC) needed for an onsite Phase 2/3 oncology study in Munich, Germany. Responsibilities focus on EDC data entry, query resolution, Investigator Site File (ISF) maintenance, and monitoring preparation.

Position Type: Part-time contract assignment; engagement structure subject to confirmation under German law

Study Oversight: Principal Investigator (PI) or authorized site designee

Duration: 12 weeks following site onboarding and authorization

Hours: 20 hours per week on site (240 total planned hours)

Location: Onsite at one clinical research site in Munich, Germany

KEY RESPONSIBILITIES

• Enter study data accurately and promptly into authorized electronic data capture (EDC) systems from approved source records.
• Review electronic case report forms (eCRFs) for completeness, accuracy, and consistency with source documentation.
• Identify missing or inconsistent data and seek clarification from authorized site personnel; escalate matters requiring clinical judgment.
• Review and resolve assigned EDC queries within study timelines in coordination with site staff and monitors.
• Maintain Investigator Site File (ISF) documents, including filing, version control, and completeness checks.
• Assist with study documentation and monitoring preparation within the agreed scope.
• Support monitor follow-up on outstanding EDC and ISF items.
• Refer clinical decisions, informed consent, and other investigator-reserved activities to authorized site personnel.
• Complete required GCP, protocol, and system training; follow site procedures and authorized access requirements.

REQUIREMENTS

• At least two years of CRC or clinical trial data coordination experience, including oncology trials.
• Experience with EDC entry, query resolution, and ISF documentation.
• Experience with Medidata Rave or comparable EDC systems preferred.
• Current GCP training and willingness to complete study-specific training.
• Fluent German and sufficient professional English for study documentation, EDC queries, and training.
• Strong organizational, communication, and prioritization skills; availability for 20 onsite hours weekly.
• Currently operating as an independent professional or registered business in Germany, with appropriate authorization and documentation.
• Previous freelance CRC or clinical research data support experience with German hospitals or research sites preferred.
• Previous DRV Statusfeststellungsbescheid confirming self-employment for comparable services advantageous, if available.
• Established independent practice, with the ability to provide services to other clients, subject to confidentiality and conflicts of interest.
• Ability to independently organize assigned work within agreed protocol deadlines, site procedures, and onsite access requirements.
• Ability to meet applicable site credentialing and onboarding requirements.
• Ability to identify and disclose relevant conflicts of interest or employment restrictions.
• Willingness to complete required RapidTrials and site onboarding.

CONFIDENTIALITY, DATA PRIVACY AND CLINICAL RESEARCH COMPLIANCE

Protect participant confidentiality and handle study data only through authorized site and study systems, in accordance with GDPR, applicable German data-protection requirements, ICH GCP, and site procedures. Do not send identifiable participant information to RapidTrials or store it in personal email, devices, or unapproved systems. Report suspected privacy or security incidents promptly through approved site channels