Clinical Research Associate (CRA) - Oncology (Remote)

Scorpion Therapeutics; Deutschland; Hybrid; EUR 85.000 - 120.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Long-term incentive

Medical/dental/vision

401(k)

Paid holidays/vacation

Zusammenfassung

Scorpion Therapeutics seeks a seasoned Clinical Research Monitor to oversee protocol and site performance, acting as the primary site contact across all study phases. You will expand the clinical research territory by developing new sites and serve as an SME for monitoring processes, ensuring data integrity and patient safety.

The role requires strong regulatory knowledge, excellent communication, and 5+ years of healthcare experience with 2+ years direct site management in bio/pharma/CRO.

Qualifikationen

• Fluent in local languages and English with excellent communication.
• Strong GCP/ICH and country clinical research law knowledge.
• Proven site management/monitoring skills and independent judgment.
• Associate or Bachelor degree with healthcare/clinical experience

Aufgaben

• Oversee protocol and site performance under CRA-Manager oversight.
• Act as primary site contact across all study phases.
• Develop clinical research territory by finding new sites.
• Serve as SME for monitoring processes and systems.
• Manage site relationships per ICH-GCP and SOPs.
• Conduct remote/on-site monitoring for data integrity and safety.
• Perform visits and complete accurate reports timely.
• Collect and review regulatory documentation for start-up/maintenance.
• Communicate with investigators about protocol conduct and recruitment.
• Identify quality issues and escalate with stakeholders.
• Maintain CTMS/eTMF documentation; support audits and co-monitoring.

Kenntnisse

Site monitoring

GCP/ICH

Clinical research

Regulatory compliance

CTMS/eTMF

Data documentation

Ausbildung

Associate degree

Bachelor's degree

Tools

CTMS

eTMF

Jobbeschreibung

Candidate must reside in: Alabama, Georgia, Colorado, Massachusetts, Michigan, Maryland, Pennsylvania.

Responsibilities

• Ensure protocol and site performance/compliance under CRA-Manager oversight (ICH-GCP, country regulations, internal policies, quality standards, adverse event reporting).
• Act as primary site contact/site manager across all study phases.
• Develop/expand clinical research territory by finding and developing new sites.
• Serve as SME for monitoring processes/systems in internal meetings.
• Manage site relationships; perform site management/monitoring per ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
• Conduct remote/on-site monitoring to ensure data integrity and subject rights/safety/well-being.
• Conduct validation/initiation/monitoring/close-out visits; complete accurate visit and contact reports timely.
• Collect/review/monitor regulatory documentation for start-up/maintenance/close-out.
• Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections.
• Identify/resolve quality/compliance issues and elevate as needed; partner with internal/external stakeholders (IRB/IECs, regulators, vendors).
• Maintain documentation in CTMS/eTMF; support/lead audits/inspections and co-monitoring.

Requirements/Qualifications

• Fluent in local languages and English (verbal/written); excellent communication.
• Strong clinical research and GCP/ICH and country clinical research law knowledge; good documentation practices.
• Proven site management/monitoring skills and independent judgment; strong IT skills.
• Associate’s degree/certificate (or equivalent) + 5+ years relevant healthcare experience with 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years.

Travel

65%–75% (about 2–3 days/week); current driver’s license required.

Benefits (if applicable)

• annual bonus and long-term incentive; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.