Location: Germany - Frankfurt & Hamburg
Therapeutic Area: Oncology
Contract Type: Freelance / Independent Contractor
Commitment: Approximately 0.5–0.8 FTE
Number of Opportunities: 5
About the Opportunity
Join an established global clinical research organisation delivering innovative, high-quality clinical development solutions across a range of therapeutic areas. With strong expertise in Oncology and Haematology, the organisation supports clinical studies across solid and haematological cancers and is committed to advancing the development of innovative treatments for patients.
We are currently seeking experienced freelance Senior Clinical Research Associates to support oncology clinical trials across Germany. This is an excellent opportunity for independent CRAs looking for a flexible contract assignment with a commitment of approximately 0.5–0.8 FTE.
The Role
As a Senior CRA, you will take responsibility for the monitoring and oversight of clinical trial sites, ensuring studies are conducted in accordance with the protocol, ICH-GCP, applicable German and EU regulations, and sponsor requirements.
You will work independently while collaborating closely with investigative sites, sponsors, and cross-functional clinical teams to ensure high-quality study delivery.
Key Responsibilities
- Conduct Site Qualification, Site Initiation, Routine Monitoring and Close-Out Visits.
- Perform on-site and remote monitoring activities across assigned oncology studies.
- Ensure compliance with study protocols, ICH-GCP, applicable regulations and SOPs.
- Conduct source data verification and review clinical trial data for accuracy and completeness.
- Identify site issues and risks and ensure appropriate follow-up and resolution.
- Maintain strong relationships with investigators and site personnel.
- Prepare monitoring visit reports and follow up on outstanding site action items.
- Support site feasibility, selection and study start-up activities where required.
- Review and collect essential and regulatory documentation and ensure appropriate filing within the eTMF/TMF.
- Maintain study and site tracking tools.
- Support the management of clinical samples and laboratory activities where applicable.
- Escalate significant issues and risks to the appropriate study stakeholders.
- Collaborate with Clinical Operations, Regulatory Affairs, Data Management and other cross-functional teams.
- Support sponsor audits, quality activities and regulatory inspections when required.
- Provide guidance and support to junior CRAs where appropriate.
- Travel to investigative sites across Germany as required.
Required Experience & Qualifications
- Minimum of 5 years' clinical research experience, including substantial independent monitoring experience.
- Previous experience as a CRA or Senior CRA managing clinical trial sites independently.
- Oncology clinical trial experience is highly desirable.
- Experience within a CRO, pharmaceutical, biotechnology or medical device environment is preferred.
- Strong knowledge of ICH-GCP and EU clinical trial regulations, with familiarity with German regulatory requirements.
- Demonstrated experience conducting SIVs, IMVs/RMVs and COVs.
- Experience supporting studies from start-up through to close-out.
- Strong experience with site management, regulatory documentation and TMF/eTMF processes.
- Proficiency in clinical trial systems, including EDC, CTMS and eTMF platforms.
- Excellent communication, organisation and stakeholder-management skills.
- Ability to work independently and manage multiple priorities effectively.
- Willingness and ability to travel across Germany as required.
- Bachelor's degree in Life Sciences or a related scientific discipline preferred.
What We're Looking For
We are looking for proactive, experienced CRAs who are comfortable working independently in a freelance capacity and taking ownership of their assigned sites. You should be confident managing the full monitoring process while maintaining a strong focus on patient safety, data quality, protocol compliance and site relationships.