Clinical Research Scientist III, Protocol Design
Overview
You will own clinical study protocol design and execution at the Director level for NexInfo Solutions. You will shape study concept sheets, protocols, and amendments that drive Phase I-IV trials. You will collaborate with cross-functional teams to ensure scientific integrity and operational feasibility. This role stands out for its hands-on involvement in CRF and Data Management Manual development under senior guidance.
What You'll Do8
- 1Design and write study concept sheets and protocols for clinical trials.
- 2Lead protocol review discussions on scientific and procedural aspects of study design.
- 3Draft protocols, amendments, and sections of study manuals and Investigator meeting notebooks.
- 4Contribute to the design of CRFs, Data Management Manuals, and data capture tools.
- 5Collaborate with biostatistics, clinical operations, and regulatory affairs to align protocol objectives.
- 6Ensure protocol compliance with ICH-GCP and regulatory standards.
- 7Present protocol designs to internal stakeholders and external investigators.
- 8Revise protocols based on scientific, operational, and regulatory feedback.
Requirements8
- 17+ years in clinical research with 3+ years in oncology or rare disease.
- 2Bachelor's degree in life sciences or related field (advanced degree preferred).
- 3In-depth knowledge of clinical trial design and ICH-GCP guidelines.
- 4Experience developing protocols, amendments, and study manuals.
- 5Proficiency in EDC systems and CTMS.
- 6Strong analytical and problem-solving skills in complex trial scenarios.
- 7Excellent written and verbal communication for cross-functional teams.
- 8Ability to work onsite in New York City.
Salary Insight
$208 - $229k per year
Location
Required Skills
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