Description
Conduct clinical research and trials to understand disease and improve human health, leading protocol design, ethical oversight, data analysis, and dissemination while ensuring compliance with GCP and regulatory standards.
- • Design and lead clinical studies and trials to evaluate disease mechanisms, prevention, diagnostics, and treatments.
- • Ensure compliance with GCP, ICH, FDA, and institutional policies throughout the study lifecycle.
- • Recruit, screen, consent, and retain participants, ensuring ethical conduct and privacy.
- • Assess safety, efficacy, pharmacokinetics, and patient outcomes of investigational drugs, biologics, or devices.
- • Monitor, document, and report adverse events and protocol deviations in a timely manner.
- • Train investigators, coordinators, and clinical staff on study protocols, SOPs, and data capture.
- • Oversee collection, processing, shipping, and analysis of clinical specimens per protocol.
- • Develop and refine protocols, including eligibility criteria, dosing, endpoints, randomization, and blinding.
- • Collaborate with sponsors, IRBs, DSMBs, regulators, and clinicians to design, execute, and monitor studies.
- • Use EDC, ePRO, EMR queries, and imaging or lab systems to capture, manage, and verify data.
- • Perform statistical analysis in partnership with biostatisticians and interpret results.
- • Prepare and submit IRB/IEC documents, informed consent forms, and regulatory filings.
- • Present findings and write manuscripts, abstracts, and reports for scientific and public audiences.
- • Write research grant proposals and contribute to budgets and timelines.
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Healthcare & Human Services
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026