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gcp edc phlebotomy ctms iata📋 Description
- Coordinate studies from start-up to close-out (feasibility, site selection, recruitment).
- Primary liaison with central IRBs; manage submissions, renewals, amendments, queries.
- Independently manage all trial phases; ensure GCP and SOP compliance.
- Recruit, screen, consent, and enroll participants per protocol.
- Perform phlebotomy and handle specimens per IATA standards.
- Maintain regulatory and study docs (CRFs, EDC, source documents) and report deviations.
🎯 Requirements
- Strong communication, organizational, problem-solving skills.
- Proficient in phlebotomy including venipuncture and processing.
- Ability to work independently and manage multiple trials.
- Knowledge of clinical research processes, FDA regulations, and IRB compliance.
- Bachelor's degree in Life Science or healthcare field; 3+ years clinical research.
- GCP and IATA certifications; CTMS/EDC experience; IRB familiarity.
🎁 Benefits
- Opportunity to advance inclusive clinical research.
- Collaborative, patient-centered team delivering virtual-first trials.
- Growth within an established startup with experienced mentors.
- Diversity and inclusion commitment.
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