Senior Clinical Trial Manager managing global Phase 3 clinical trials for oncology at Verastem Oncology. Overseeing vendor management, budget adherence, and regulatory compliance throughout the project lifecycle.
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Hybrid Clinical Research Coordinator II – Movement Disorders and Stroke Research Programs
Posted last week
About the role
- Clinical Research Coordinator II coordinating research visits and participant eligibility for movement disorders and stroke studies. Involves regulatory compliance and data management.
Responsibilities
- Scheduling of research participants for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
- Schedules and participates in monitoring and auditing activities.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.
- May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
- Coordinates training and education of other personnel.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- Maintains accurate source documents related to all research procedures.
Requirements
- High School Diploma/GED, required.
- Bachelor's degree in a Science, Sociology, or related field, preferred.
- ACRP/SOCRA certification is preferred.
- 2 years of clinical research related experience, required.
Benefits
- Not specified.
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