Related skills
gcp edc phlebotomy ctms fda📋 Description
- Coordinate and execute studies from start-up through close-out.
- Liaise with central IRBs; manage submissions, renewals, amendments.
- Independently manage all trial phases with GCP and SOP compliance.
- Recruit, screen, consent, and enroll participants per protocol.
- Perform phlebotomy and handle specimens per IATA standards.
- Maintain regulatory/docs: CRFs, EDC, source docs.
🎯 Requirements
- Strong communication, organizational, and problem-solving skills.
- Proficient in phlebotomy and specimen processing.
- Independently manage multiple clinical trials with GCP/IRB compliance.
- Bachelor’s in Life Science or healthcare field; 3+ years sponsor clinical research (Allergy/Immunology preferred).
- Current GCP and IATA certifications; CTMS/EDC experience.
- Central IRB submissions and regulatory binder creation.
🎁 Benefits
- Opportunity to re-envision inclusive clinical research.
- Work with a patient-centered, collaborative team delivering virtual-first clinical research at scale.
- Grow within an established startup with industry veterans and investors.
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